DePuy Synthes Maxillofacial Portfolio - MR Conditional

K183113 · Synthes (USA) Products, LLC · MQN · Mar 13, 2019 · Dental

Device Facts

Record IDK183113
Device NameDePuy Synthes Maxillofacial Portfolio - MR Conditional
ApplicantSynthes (USA) Products, LLC
Product CodeMQN · Dental
Decision DateMar 13, 2019
DecisionSESE
Submission TypeTraditional
Regulation21 CFR 872.4760
Device ClassClass 2
AttributesTherapeutic, Pediatric

Intended Use

The DePuy Synthes IMF Screws are intended to provide indirect stabilization of the maxilla and mandible following maxillofacial and mandibular trauma or reconstruction. The DePuy Synthes Titanium Multi-Vector is intended for use in mandbular bone lengthening for conditions such as mandibular hypoplasia or post-traumatic defects such as tumor resections, severe trauma, bone grafting defects, severe open mandible fractures where gradual bone distraction is required. Where bone loss is a result of the condition, bone transport can be performed as an alternative to free flaps or bone grafts. The DePuy Synthes Low Profile Neuro System - 3 mm Screws is intended for use in selective trauma of the midface and maxillofacial skeleton; maxillofacial surgery; reconstructive procedures; and selective orthognathic surgery of the maxilla and chin. The DePuy Synthes External Midface Distractor is intended for use in maxillofacial surgery, reconstructive procedures, and selective orthognathic surgery of the maxilla. Specifically, it is intended for distraction of the maxilla utilizing a LeFort I osteotomy and/or the midface utilizing a LeFort II or III osteotomy in adult and pediations where gradual bone distraction is required. The DePuy Synthes 1.0/1.2 mm Craniofacial Screws are intended for use as follows: General Indications: · Maxillofacial surgery. The DePuy Synthes Alveolar Distractor is intended for vertical bone lengthening of the alveolar ridge in the mandible and the maxilla where gradual bone distraction is required, including deficiency in bone height as a result of trauma, resorption after dental extraction, periodontal disease, tumor resection, and congenital deformity. The DePuy Synthes Craniomaxillofacial Distraction System (CMF Distraction System) is intended for use as a bone stabilizer and lengthening (and/or transport) device for correction of congenital deficiencies or post-traumatic defects of the mandibular body and ramus where gradual bone distraction is required. The DePuy Synthes CMF Distraction System is intended for single use only. The DePuy Synthes Pediatric CMF Distraction System is intended for use as a bone stabilizer and lengthening (and/or transport) device for correction of congenital deficiencies or post-traumatic defects of the mandibular body and ramus where gradual bone distraction is required in children under the age of 12 months. The DePuy Synthes Pediativ CMF Distraction System is intended for single use only. The DePuy Synthes Condylar Head Add-On System is intended for temporary reconstruction in patients undergoing ablative tumor surgery requiring the removal of the mandibular condyle. This device is not for permanent implantation, for patients with TMJ or traumatic injuries, or for treatment of temporomandibular joint disease (TMD). The DePuy Synthes Curvilinear Distraction System is intended for use as a bone stabilizer and lengthening (and/or transport) device for correction of congenital deficiencies or post-traumatic defects of the mandibular body and ramus where gradual bone distraction is required. This system is intended for use in either adults or pediatric patients over 1 year old. The DePuy Synthes Curvilinear Distraction System is intended for single use only. The DePuy Synthes Condylar Head Add-On System Intended for temporary reconstruction in patients undergoing ablative tumor surgery requiring the removal of the mandibular condyle. This device is not for permanent implantation. for patients with TMJ or traumatic injuries, or for treatment of temporomandibular joint disease (TMD). The DePuy Synthes Orthodontic Bone Anchor (OBA) System screw anchors are intended to be implanted intraorally and used as an anchor for orthodontic procedures in adolescents greater than age 12 and adults. The DePuy Synthes Orthodontic Bone Anchor (OBA) System plate anchors are intended to be implanted intraorally and used as an anchor for orthodontic procedures in adults. The DePuy Synthes Curvilinear Distraction System is intended for use as a bone stabilizer and lengthening (and/or transport) device. The DePuy Synthes Curvilinear Distraction System is indicated for correction of congenital deficiencies or posttraumatic defects of the mandibular body and ramus where gradual bone distraction is required. The 2.0 mm Curvilinear Distractor is intended for use in adult and pediatric patients more than 1 year old. The 1.3 mm Curvilinear Distractor is intended for use in pediatric patients 4 years of age and younger. The DePuy Synthes Curvilinear Distraction System is intended for single use only. The DePuy Synthes Mandible Distractor is intended to be used in the mandible for conditions such as mandibular deficiency or post-traumatic effects of the mandible, where gradual bone distraction is required. The DePuy Synthes SMF Stainless Steel Bone Screws are intended for maxillofacial and mandbular trauma and reconstruction. The longer screw lengths (24-38mm) are specifically intended for symphysial fractures, parasymphyseal fractures, and angle fractures where the lag screw technique is being followed. The lag screw technique involves overdrilling the near cortex, thus the screw glides through the near cortical and cancellous bone and purchases only into the far cancellous and cortical bone. The DePuy Synthes 1.5 mm/2.0 mm Orthognathic Maxillary Plates and Screws are generally intended for a variety of pan facial indications. Specifically, it is intended for selective trauma of the midface and maxillofacial skeleton; maxillofacial surgery; reconstructive procedures; and selective orthognathic surgery of the maxilla and chin. The DePuy Synthes Single Vector Distractor with Detachable Feet is intended for use as a bone stabilizer and lengthener for conditions such as mandibular hypoplasia or post-traumatic defects of the mandible, where gradual bone distraction is required. The device is ideal for treating fonns of clefts of the lip and palate, and congenital mandibular hypoplasia, such as Hemifacial Microsomia, Treacher Collins Syndrome, Pierre Robin Syndrome, Goldenhar Syndrome, Apert Syndrome, and Crouzon Syndrome. The DePuy Synthes Single Vector Distractor with Detachable Feet is also ideal for treating hypoplasias of an acquired origin such as from post-traumatic growth disorders associated with injury to the temporomandibular joint, temporomandibular ankylosis, and segmental loss of bone. The DePuy Synthes External Multi Vector Mandible Distractor (MVMD) is intended for use as a bone stabilizer and lengthener for conditions such as mandibular hypoplasia or posttraumatic defects of the mandible, where gradual bone distraction is required. The device is ideal for treating any form of congenital mandibular hypoplasia, such as Hemifacial Micorsomia, Treacher Collins Syndrome, Nagers Syndrome, Pierre Robin Syndrome, Goldenhar Syndrome, Apert Syndrome, and Crouzon Syndrome. The DePuy Synthes External MVMD is also ideal for treating hypoplasias of an acquired origin such as from posttraumatic growth disorders associated with injury to the temporomandibular joint, temporomandibular ankylosis, and segmental loss of bone. The DePuy Synthes Locking Reconstruction Plate (LRP) with Condylar Head is intended for temporary reconstruction in patients undergoing ablative tumor surgery requiring the removal of the mandibular condyle. This device is not for permanent implantation, for patients with TMJ or traumatic injuries, or for treatment of temporomandibular joint disease (TMD). The DePuy Synthes Cerclage Wires are indicated for use in adults and children to directly wire bony segments together, for the fixation of arch bars or splints to the teeth, for stabilization of bony segments, or for wiring the teeth together maxillomandibular fixation).

Device Story

Portfolio of maxillofacial fixation and distraction devices (screws, plates, distractors, wires) for bone stabilization, lengthening, and reconstruction. Devices are implanted intraorally or subcutaneously by surgeons to treat trauma, congenital deficiencies (e.g., mandibular hypoplasia), or post-traumatic defects. Distractors use mechanical activation (jack screws, worm gears) to gradually advance bone segments. Screws and plates provide rigid fixation. Devices are used in clinical settings; operated by surgeons. Output is physical bone stabilization or gradual distraction. Benefits include correction of skeletal deformities and restoration of bone structure. This submission adds MR Conditional labeling to existing cleared devices.

Clinical Evidence

Bench testing only. No clinical data provided. Non-clinical testing performed per ASTM F2052-14 (displacement), ASTM F2213-06 (torque), ASTM F2182-11a (RF heating), and ASTM F2119-07 (image artifacts) to support MR Conditional safety.

Technological Characteristics

Materials: Titanium alloy (Ti-6Al-7Nb), commercially pure titanium, stainless steel, chromium cobalt alloy. Mechanical distraction via jack screws, worm gears, or manual activation. Fixation via screws/plates. MR Conditional. Non-sterile supply.

Indications for Use

Indicated for maxillofacial/mandibular trauma, reconstruction, bone lengthening, and orthodontic anchoring in adult and pediatric populations (age ranges vary by specific device, e.g., >1 year, >4 years, >12 years). Contraindicated for permanent implantation in specific condylar head systems or for TMJ/TMD treatment.

Regulatory Classification

Identification

A bone plate is a metal device intended to stabilize fractured bone structures in the oral cavity. The bone segments are attached to the plate with screws to prevent movement of the segments.

Predicate Devices

Reference Devices

Related Devices

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and "ADMINISTRATION" in a smaller font size below. March 13, 2019 Synthes (USA) Products LLC Rebecca Reiter Regulatory Affairs Project Leader 1301 Goshen Parkway West Chester, Pennsylvania 19380 Re: K183113 Trade/Device Name: DePuv Synthes Maxillofacial Portfolio - MR Conditional Regulation Number: 21 CFR 872.4760 Regulation Name: Bone Plate Regulatory Class: Class II Product Code: MON, DZL, NEI, OAT, DZK Dated: February 14, 2019 Received: February 15, 2019 Dear Rebecca Reiter: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. {1}------------------------------------------------ Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, # Andrew I. Steen -S for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ 510(k) Number (if known) K183113 Device Name DePuy Synthes Maxillofacial Portfolio - MR Conditional Indications for Use (Describe) DePuy Synthes IMF Screws (originally cleared per K010527) The DePuy Synthes IMF Screws are intended to provide indirect stabilization of the maxilla and mandible following maxillofacial and mandibular trauma or reconstruction. Type of Use (Select one or both, as applicable) | <span style="font-family: Arial;"> <span style="font-size: 10pt;">☑ Prescription Use (Part 21 CFR 801 Subpart D)</span> </span> | |---------------------------------------------------------------------------------------------------------------------------------| | <span style="font-family: Arial;"> <span style="font-size: 10pt;">☐ Over-The-Counter Use (21 CFR 801 Subpart C)</span> </span> | ## CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov {3}------------------------------------------------ 510(k) Number (if known) K183113 Device Name DePuy Synthes Maxillofacial Portfolio - MR Conditional ### Indications for Use (Describe) DePuy Synthes Titanium Multi-Vector Distractor (originally cleared per K010690) The DePuy Synthes Titanium Multi-Vector is intended for use in mandbular bone lengthening for conditions such as mandibular hypoplasia or post-traumatic defects such as tumor resections, severe trauma, bone grafting defects, severe open mandible fractures where gradual distraction is required. Where bone loss is a result of the condition, bone transport can be performed as an alternative to free flaps or bone grafts. | Type of Use (Select one or both, as applicable) | | |-------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------| | <label><input checked="" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</label> | <label><input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</label> | ## CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ## *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov {4}------------------------------------------------ 510(k) Number (if known) K183113 Device Name DePuy Synthes Maxillofacial Portfolio - MR Conditional ### Indications for Use (Describe) DePuy Synthes Low Profile Neuro System - 3 mm Screws (originally cleared via K031807) The DePuy Synthes Low Profile Neuro System - 3 mm Screws is intended for use in selective trauma of the midface and maxillofacial skeleton; maxillofacial surgery; reconstructive procedures; and selective orthognathic surgery of the maxilla and chin. | Type of Use (Select one or both, as applicable) | | |--------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------| | <div> <span> <span style="font-size: 100%;"> </span> </span> <span style="font-size: 100%;">Prescription Use (Part 21 CFR 801 Subpart D)</span> </div> | <div> <span> <span style="font-size: 100%;"> </span> </span> <span style="font-size: 100%;">Over-The-Counter Use (21 CFR 801 Subpart C)</span> </div> | ## CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov {5}------------------------------------------------ 510(k) Number (if known) K183113 Device Name DePuy Synthes Maxillofacial Portfolio - MR Conditional Indications for Use (Describe) DePuy Synthes External Midface Distractor (originally cleared via K040083) The DePuy Synthes External Midface Distractor is intended for use in maxillofacial surgery, reconstructive procedures, and selective orthognathic surgery of the maxilla. Specifically, it is intended for distraction of the maxilla utilizing a LeFort I osteotomy and/or the midface utilizing a LeFort II or III osteotomy in adult and pediations where gradual bone distraction is required. | Type of Use (Select one or both, as applicable) | | |---------------------------------------------------------------|--------------------------------------------------------------| | <div> Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> Over-The-Counter Use (21 CFR 801 Subpart C) </div> | ## CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ## *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov {6}------------------------------------------------ 510(k) Number (if known) K183113 Device Name DePuy Synthes Maxillofacial Portfolio - MR Conditional Indications for Use (Describe) DePuy Synthes 1.0/1.2 mm Craniofacial Screws (originally cleared per K041887) The DePuy Synthes 1.0/1.2 mm Craniofacial Screws are intended for use as follows: General Indications: · Maxillofacial surgery Type of Use (Select one or both, as applicable) | Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) | |----------------------------------------------|---------------------------------------------| |----------------------------------------------|---------------------------------------------| | > Prescription Use (Part 21 CFR 801 Subpart D) |__ | Over-The-Counter Use (21 CFR 801 Subpart C) ## CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ## *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov {7}------------------------------------------------ 510(k) Number (if known) K183113 Device Name DePuy Synthes Maxillofacial Portfolio - MR Conditional Indications for Use (Describe) DePuy Synthes Alveolar Distractor (originally cleared per K043555) The DePuy Synthes Alveolar Distractor is intended for vertical bone lengthening of the alveolar ridge in the mandible and the maxilla where gradual bone distraction is required, including deficiency in bone height as a result of trauma, resorption after dental extraction, periodontal disease, tumor resection, and congenital deformity. | Type of Use (Select one or both, as applicable) | | |--------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------| | <span style="text-decoration: underline;"><b>X</b></span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="text-decoration: underline;"> </span> Over-The-Counter Use (21 CFR 801 Subpart C) | ## CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov {8}------------------------------------------------ 510(k) Number (if known) K183113 ### Device Name DePuy Synthes Maxillofacial Portfolio - MR Conditional ### Indications for Use (Describe) DePuy Synthes Craniomaxillofacial Distraction System (CMF Distraction System) (originally cleared per K060138) The DePuy Synthes Craniomaxillofacial Distraction System (CMF Distraction System) is intended for use as a bone stabilizer and lengthening (and/or transport) device for correction of congenital deficiencies or post-traumatic defects of the mandibular body and ramus where gradual bone distraction is required. The DePuy Synthes CMF Distraction System is intended for single use only. The DePuy Synthes Pediatric CMF Distraction System is intended for use as a bone stabilizer and lengthening (and/or transport) device for correction of congenital deficiencies or post-traumatic defects of the mandibular body and ramus where gradual bone distraction is required in children under the age of 12 months. The DePuy Synthes Pediativ CMF Distraction System is intended for single use only. Type of Use (Select one or both, as applicable) | <span style="font-family: sans-serif;"> <svg fill="none" height="16" viewbox="0 0 16 16" width="16" xmlns="http://www.w3.org/2000/svg"> <path d="M13.3333 2H2.66667C2.29845 2 2 1.70155 2 1.33333V14.6667C2 15.0349 2.29845 15.3333 2.66667 15.3333H13.3333C13.7016 15.3333 14 15.0349 14 14.6667V1.33333C14 1.70155 13.7016 2 13.3333 2ZM13.3333 14.6667H2.66667V1.33333H13.3333V14.6667ZM12 4.66667H4V6H12V4.66667ZM12 8H4V9.33333H12V8ZM12 11.3333H4V12.6667H12V11.3333Z" fill="black"></path> </svg> </span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="font-family: sans-serif;"> <svg fill="none" height="16" viewbox="0 0 16 16" width="16" xmlns="http://www.w3.org/2000/svg"> <rect height="12" stroke="black" stroke-width="1.33333" width="12" x="2" y="2"></rect> </svg> </span> Over-The-Counter Use (21 CFR 801 Subpart C) | |---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| |---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| ## CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ## *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov {9}------------------------------------------------ 510(k) Number (if known) K183133 Device Name DePuy Synthes Maxillofacial Portfolio - MR Conditional ### Indications for Use (Describe) DePuy Synthes Condylar Head Add-On System (originally cleared per K063181) The DePuy Synthes Condylar Head Add-On System is intended for temporary reconstruction in patients undergoing ablative tumor surgery requiring the removal of the mandibular condyle. This device is not for permanent implantation, for patients with TMJ or traumatic injuries, or for treatment of temporomandibular joint disease (TMD). | Type of Use (Select one or both, as applicable) | | |----------------------------------------------------------------------------------|----------------------------------------------------------------------| | <input checked="" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) | <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) | ## CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov {10}------------------------------------------------ 510(k) Number (if known) K183113 Device Name DePuy Synthes Maxillofacial Portfolio - MR Conditional ### Indications for Use (Describe) DePuy Synthes Curvilinear Distraction System (originally cleared per K080153) The DePuy Synthes Curvilinear Distraction System is intended for use as a bone stabilizer and lengthening (and/or transport) device for correction of congenital deficiencies or post-traumatic defects of the mandibular body and ramus where gradual bone distraction is required. This system is intended for use in either adults or pediatric patients over 1 year old. The DePuy Synthes Curvilinear Distraction System is intended for single use only. | Type of Use (Select one or both, as applicable) | | |---------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------| | <table><tr><td><span style="font-size:16px">☑</span> Prescription Use (Part 21 CFR 801 Subpart D)</td></tr></table> | <span style="font-size:16px">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) | | <span style="font-size:16px">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) | | | <table><tr><td><span style="font-size:16px">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C)</td></tr></table> | <span style="font-size:16px">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) | | <span style="font-size:16px">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) | | ## CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ## *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov {11}------------------------------------------------ 510(k) Number (if known) K183113 Device Name DePuy Synthes Maxillofacial Portfolio - MR Conditional ### Indications for Use (Describe) Modification to DePuy Synthes Condylar Head Add-On System (originally cleared per K081747) The DePuy Synthes Condylar Head Add-On System Intended for temporary reconstruction in patients undergoing ablative tumor surgery requiring the removal of the mandibular condyle. This device is not for permanent implantation. for patients with TMJ or traumatic injuries, or for treatment of temporomandibular joint disease (TMD). | Type of Use (Select one or both, as applicable) | | |------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------| | <span style="font-size:16px">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="font-size:16px">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) | ## CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ## *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov {12}------------------------------------------------ 510(k) Number (if known) K183113 Device Name DePuy Synthes Maxillofacial Portfolio - MR Conditional ### Indications for Use (Describe) DePuy Synthes Orthodontic Bone Anchor (OBA) System (originally cleared per K093299) The DePuy Synthes Orthodontic Bone Anchor (OBA) System screw anchors are intended to be implanted intraorally and used as an anchor for orthodontic procedures in adolescents greater than age 12 and adults. The DePuy Synthes Orthodontic Bone Anchor (OBA) System plate anchors are intended to be implanted intraorally and used as an anchor for orthodontic procedures in adults. Type of Use (Select one or both, as applicable) | <span></span> | <input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) | |---------------|--------------------------------------------------------------------------------------| | <span></span> | <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) | ## CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ## *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov {13}------------------------------------------------ 510(k) Number (if known) K183113 Device Name DePuy Synthes Maxillofacial Portfolio - MR Conditional Indications for Use (Describe) DePuy Synthes Curvilinear Distraction System (originally cleared per K121502) The DePuy Synthes Curvilinear Distraction System is intended for use as a bone stabilizer and lengthening (and/or transport) device. The DePuy Synthes Curvilinear Distraction System is indicated for correction of congenital deficiencies or posttraumatic defects of the mandibular body and ramus where gradual bone distraction is required. The 2.0 mm Curvilinear Distractor is intended for use in adult and pediatric patients more than 1 year old. The 1.3 mm Curvilinear Distractor is intended for use in pediatric patients 4 years of age and younger. The DePuy Synthes Curvilinear Distraction System is intended for single use only. | Type of Use (Select one or both, as applicable) | | |-------------------------------------------------|---------------------------------------------| | Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) | ## CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ## *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov {14}------------------------------------------------ 510(k) Number (if known) K183113 ### Device Name DePuy Synthes Maxillofacial Portfolio - MR Conditional Indications for Use (Describe) DePuy Synthes Mandible Distractor (originally cleared per K962272) The DePuy Synthes Mandible Distractor is intended to be used in the mandible for conditions such as mandibular deficiency or post-traumatic effects of the mandible, where gradual bone distraction is required. | Type of Use (Select one or both, as applicable) | | |--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | <span style="font-family: Arial, sans-serif;"> <span style="font-size: 10pt;"> <span style="color: black;"> <span style="font-weight: bold;">Prescription Use (Part 21 CFR 801 Subpart D)</span> </span> </span> </span> | <span style="font-family: Arial, sans-serif;"> <span style="font-size: 10pt;"> <span style="color: black;"> <span style="font-weight: bold;">Over-The-Counter Use (21 CFR 801 Subpart C)</span> </span> </span> </span> | ## CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov {15}------------------------------------------------ 510(k) Number (if known) K183113 Device Name DePuy Synthes Maxillofacial Portfolio - MR Conditional ### Indications for Use (Describe) DePuy Synthes SMF Stainless Steel Bone Screws (originally cleared via K964261) The DePuy Synthes SMF Stainless Steel Bone Screws are intended for maxillofacial and mandbular trauma and reconstruction. The longer screw lengths (24-38mm) are specifically intended for symphysial fractures, parasymphyseal fractures, and angle fractures where the lag screw technique is being followed. The lag screw technique involves overdrilling the near cortex, thus the screw glides through the near cortical and cancellous bone and purchases only into the far cancellous and cortical bone. X Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) ## CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov {16}------------------------------------------------ 510(k) Number (if known) K183113 Device Name DePuy Synthes Maxillofacial Portfolio - MR Conditional ### Indications for Use (Describe) DePuy Synthes 1.5 mm/2.0 mm Orthognathic Maxillary Plates and Screws (originally cleared per K980199) The DePuy Synthes 1.5 mm/2.0 mm Orthognathic Maxillary Plates and Screws are generally intended for a variety of pan facial indications. Specifically, it is intended for selective trauma of the midface and maxillofacial surgery; reconstructive procedures; and selective orthognathic surgery of the maxilla and chin. Type of Use (Select one or both, as applicable) | Prescription Use (Part 21 CFR 801 Subpart D) | <span style="font-size: 20px;">☑</span> | |----------------------------------------------|-----------------------------------------| | Over-The-Counter Use (21 CFR 801 Subpart C) | <span style="font-size: 20px;">☐</span> | ## CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ## *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov {17}------------------------------------------------ 510(k) Number (if known) K183113 Device Name DePuy Synthes Maxillofacial Portfolio - MR Conditional ### Indications for Use (Describe) DePuy Synthes Single Vector Distractor with Detachable Feet (originally cleared per K981075) The DePuy Synthes Single Vector Distractor with Detachable Feet is intended for use as a bone stabilizer and lengthener for conditions such as mandibular hypoplasia or post-traumatic defects of the mandible, where gradual bone distraction is required. The device is ideal for treating fonns of clefts of the lip and palate, and congenital mandibular hypoplasia, such as Hemifacial Microsomia, Treacher Collins Syndrome, Pierre Robin Syndrome, Goldenhar Syndrome, Apert Syndrome, and Crouzon Syndrome. The DePuy Synthes Single Vector Distractor with Detachable Feet is also ideal for treating hypoplasias of an acquired origin such as from post-traumatic growth disorders associated with injury to the temporomandibular joint, temporomandibular ankylosis, and segmental loss of bone. | Type of Use (Select one or both, as applicable) | |-------------------------------------------------| |-------------------------------------------------| X Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) ## CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ## *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov {18}------------------------------------------------ 510(k) Number (if known) K183113 Device Name DePuy Synthes Maxillofacial Portfolio - MR Conditional ### Indications for Use (Describe) DePuy Synthes External Multi Vector Mandible Distractor (MVMD) (originally cleared via K981362) The DePuy Synthes External Multi Vector Mandible Distractor (MVMD) is intended for use as a bone stabilizer and lengthener for conditions such as mandibular hypoplasia or posttraumatic defects of the mandible, where gradual bone distraction is required. The device is ideal for treating any form of congenital mandibular hypoplasia, such as Hemifacial Micorsomia, Treacher Collins Syndrome, Nagers Syndrome, Pierre Robin Syndrome, Goldenhar Syndrome, Apert Syndrome, and Crouzon Syndrome. The DePuy Synthes External MVMD is also ideal for treating hypoplasias of an acquired origin such as from posttraumatic growth disorders associated with injury to the temporomandibular joint, temporomandibular ankylosis, and segmental loss of bone. Type of Use (*Select one or both, as applicable*) | <div> <span> <span style="font-size: 16px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | |----------------------------------------------------------------------------------------------------------------------| | <div> <span> <span style="font-size: 16px;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> | ## CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ## *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov {19}------------------------------------------------ 510(k) Number (if known) K183113 Device Name DePuy Synthes Maxillofacial Portfolio - MR Conditional ### Indications for Use (Describe) DePuy Synthes Locking Reconstruction Plate (LRP) with Condylar Head (originally cleared per K990637) The DePuy Synthes Locking Reconstruction Plate with Condylar Head is intended for temporary reconstruction in patients undergoing ablative tumor surgery requiring the removal of the mandibular condyle. This device is not for permanent implantation, for patients with TMJ or traumatic injuries, or for treatment of temporomandibular joint disease (TMD). Type of Use (Select one or both, as applicable) | <span style="font-size: 10pt;">☑ Prescription Use (Part 21 CFR 801 Subpart D)</span> | |--------------------------------------------------------------------------------------| | <span style="font-size: 10pt;">☐ Over-The-Counter Use (21 CFR 801 Subpart C)</span> | ## CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ## *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov {20}------------------------------------------------ 510(k) Number (if known) K183113 Device Name DePuy Synthes Maxillofacial Portfolio - MR Conditional Indications for Use (Describe) DePuy Synthes Cerclage Wires (originally Pre-Amendment) The DePuy Synthes Cerclage Wires are indicated for use in adults and children to directly wire bony segments together, for the fixation of arch bars or splints to the teeth, for stabilization of bony segments, or for wiring the teeth together maxillomandibular fixation). Type of Use (Select one or both, as applicable) | <div> <span> <svg height="16" width="16"> <polygon points="1,0 15,0 15,14 1,14" style="fill:none;stroke:black;stroke-width:1"></polygon> <polygon points="2,2 8,8 14,2 14,3 8,9 2,3" style="fill:black;stroke:black;stroke-width:1"></polygon> </svg> </span> Prescription Use (Part 21 CFR 801 Subpart D) </div> | |--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | <div> <span> <svg height="16" width="16"> <polygon points="1,0 15,0 15,14 1,14" style="fill:none;stroke:black;stroke-width:1"></polygon> </svg> </span> Over-The-Counter Use (21 CFR 801 Subpart C) </div> | ## CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov {21}------------------------------------------------ Image /page/21/Picture/0 description: The image shows the logo for DePuy Synthes, which is part of the Johnson & Johnson family of companies. The logo includes a symbol that looks like two overlapping circles, followed by the company name in blue, and the tagline "People inspired" in gold. The text "PART OF THE Johnson+Johnson FAMILY OF COMPANIES" is written in a smaller font below the company name. ### 510(k) Summary 1. Date Prepared: March 7, 2019 ### 1.1. Submitter ## Primary Contact: Rebecca Reiter Regulatory Affairs Project Leader DePuy Synthes 1301 Goshen Parkway West Chester, PA 19380 Phone: 610-719-1268 Email: rreiter@its.jnj.com ## Alternate Contact: Elizabeth Jacobs Regulatory Affairs Project Leader DePuy Synthes 1301 Goshen Parkway West Chester, PA 19380 Phone: (610) 719-5768 Email: ejacob10@its.jnj.com ### 1.2. Device Trade Name: DePuy Synthes Maxillofacial Portfolio - MR Conditional Name of Device: DePuy Synthes IMF Screws Classification Name(s): Screw, Fixation, Intraosseous Regulatory Class: Class II; 872.4880 Product Code(s): DZL - 1.3. Predicate Device K010527 Synthes IMF Screws ### Device Description 1.4. This document is regarding the DePuy Synthes IMF Screws, which are a subset of the DePuy Synthes Maxillofacial Portfolio - MR Conditional. The DePuy Synthes IMF Screws are designed with cross-axial through holes and a circumferential relief groove to accommodate wire or elastic bands. The IMF Screws are self-drilling, 2.0 mm in diameter, and available in thread lengths of 6mm to 12mm. The devices in scope of K183113 are being reviewed for MR Conditional labeling for maxillofacial indications. {22}------------------------------------------------ Image /page/22/Picture/0 description: The image shows the logo for DePuy Synthes, which is part of the Johnson & Johnson family of companies. The logo includes a symbol of two overlapping circles, followed by the company name in blue text. Below the company name is the phrase "PART OF THE Johnson & Johnson FAMILY OF COMPANIES" in smaller text. To the right of the company name is the phrase "People inspired" in a cursive font. The DePuy Synthes IMF Screws are intended to provide indirect stabilization of the maxilla and mandible following maxillofacial and mandibular trauma or reconstruction. ### Substantial Equivalence 1.6. The purpose of this submission is to add MR Conditional information to the device labeling for the DePuy Synthes IMF Screws. Changes in the Indications for Use Statement are to remove language not specific to maxillofacial surgeries, as these (e.g., craniofacial) indications are not reviewed by the Dental Review Panel. The technological characteristics of the devices remains unchanged. The device name has been updated to reflect the current company name, DePuy Synthes. An indications for use comparison table is provided below. | K183113 | K010527 | |-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------| | The DePuy Synthes IMF Screws are intended<br>to provide indirect stabilization of the maxilla<br>and mandible following maxillofacial and<br>mandibular trauma or reconstruction. | To provide indirect stabilization of the maxilla<br>and mandible following craniofacial and<br>mandibular trauma or reconstruction. | ### Non-Clinical Testing Summary 1.7. Non-clinical testing is provided to support the conditional safety of the DePuy Synthes IMF Screws in the MR environment including assessment of magnetically induced displacement force (ASTM F2052-14) and torque (ASTM F2213-06), radio frequency (RF) heating (ASTM F2182-11a and DUKE model), and image artifacts (ASTM F2119-07). The DUKE model places devices in the clinically relevant anatomic position. The DUKE results will be used for labeling of RF heating. {23}------------------------------------------------ Image /page/23/Picture/0 description: The image shows the logo for DePuy Synthes, which is part of the Johnson & Johnson family of companies. The logo consists of a circular symbol with two curved lines inside, followed by the text "DePuy Synthes" in a dark blue sans-serif font. To the right of the company name, the phrase "People inspired" is written in a cursive, gold-colored font. ### 510(k) Summarv 1. Date Prepared: March 7, 2019 ### 1.1. Submitter Primary Contact: Rebecca Reiter Regulatory Affairs Project Leader DePuy Synthes 1301 Goshen Parkway West Chester, PA 19380 Phone: 610-719-1268 Email: rreiter@its.jnj.com Alternate Contact: Elizabeth Jacobs Regulatory Affairs Project Leader DePuy Synthes 1301 Goshen Parkway West Chester, PA 19380 Phone: (610) 719-5768 Email: ejacob10@its.jnj.com ## 1.2. Device Trade Name: DePuy Synthes Maxillofacial Portfolio - MR Conditional Name of Device: DePuy Synthes Titanium Multi-Vector Distractor Classification Name(s): Screw, Fixation, Intraosseous Regulatory Class: Class II; 872.4880 Product Code(s): DZL #### 1.3. Predicate Device K010690 Synthes Titanium Multi-Vector Distractor #### Device Description 1.4. This document is regarding the DePuy Synthes Titanium Multi-Vector Distractor, which are a supset of the DePuy Synthes Maxillofacial Portfolio-MR Conditional. The DePuy Synthes Titanium Multi-Vector Distractor (MVD) is a bone lengthening and distraction device that functions by gradually activating the device in a linear, angular, and/or transverse fashion. Bone stabilization may also be accomplished with this device after distraction. The device is comprised of interchangeable distraction arms, various pin clamps, socket and hex head screws, rods, and activation nuts. All MVD pin clamps accommodate 2.0mm k-wires. The {24}------------------------------------------------ Image /page/24/Picture/0 description: The image shows the logo for DePuy Synthes, which is part of the Johnson & Johnson family of companies. The logo features a stylized, circular symbol to the left of the company name, "DePuy Synthes," written in a bold, blue font. To the right of the company name, the phrase "People inspired" is written in a cursive, gold font. Below the company name, there is a smaller line of text that reads "PART OF THE Johnson & Johnson FAMILY OF COMPANIES". devices in scope of K183113 are being reviewed for MR Conditional labeling for maxillofacial indications. ### Indications for Use 1.5. The DePuy Synthes Titanium Multi-Vector Distractor is intended for use in mandibular bone lengthening for conditions such as mandibular hypoplasia or post-traumatic defects such as tumor resections, severe trauma, bone grafting defects, severe open mandible fractures where gradual distraction is required. Where bone loss is a result of the condition, bone transport can be performed as an alternative to free flaps or bone grafts. ### Substantial Equivalence 1.6. The purpose of this submission is to add MR Conditional information to the device labeling for the DePuy Synthes Titanium Multi-Vector Distractor. The intended use and technological characteristics of the devices remains unchanged. The device name has been updated to reflect the current company name, DePuy Synthes. An indications for use comparison table is provided below. | K183113 | K010690 | |------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | The DePuy Synthes Titanium Multi-Vector<br>Distractor is intended for use in mandibular<br>bone lengthening for conditions such as<br>mandibular hypoplasia or post-traumatic<br>defects such as tumor resections, severe | For use in mandibular bone lengthening for<br>conditions such as mandibular hypoplasia or<br>post-traumatic defects such as tumor<br>resections, severe trauma, bone grafting<br>defects, severe open mandible fractures | | trauma, bone grafting defects, severe open<br>mandible fractures where gradual distraction<br>is required. Where bone loss is a result of the<br>condition, bone transport can be performed as<br>an alternative to free flaps or bone grafts. | where gradual distraction is required. Where<br>bone loss is a result of the condition, bone<br>transport can be performed as an alternative<br>to free flaps or bone grafts. | {25}------------------------------------------------ Image /page/25/Picture/0 description: The image shows the logo for DePuy Synthes, which is part of the Johnson & Johnson family of companies. The logo features a symbol of two overlapping circles in a tan color, followed by the company name in blue, "DePuy Synthes". To the right of the company name is the phrase "People inspired" in a cursive font and tan color. Below the company name is the phrase "PART OF THE Johnson-Johnson FAMILY OF COMPANIES" in a smaller font size. ### Non-Clinical Testing Summary 1.7. Non-clinical testing is provided to support the conditional safety of the DePuy Synthes Titanium Multi-Vector Distractor in the MR environment including assessment of magnetically induced displacement force (ASTM F2052-14) and torque (ASTM F2213-06), radio frequency (RF) heating (ASTM F2182-11a and DUKE model), and image artifacts (ASTM F2119-07). The DUKE model places devices in the clinically relevant anatomic position. The DUKE results will be used for labeling of RF heating. {26}------------------------------------------------ Image /page/26/Picture/0 description: The image shows the logo for DePuy Synthes, which is part of the Johnson & Johnson family of companies. The logo consists of a symbol that looks like two overlapping circles, followed by the text "DePuy Synthes" in blue. Below the text is the phrase "PART OF THE Johnson & Johnson FAMILY OF COMPANIES" in a smaller font. To the right of the company name is the phrase "People inspired" in a cursive font. ### 510(k) Summary 1. Date Prepared: March 7, 2019 ### 1.1. Submitter Primary Contact: Rebecca Reiter Regulatory Affairs Project Leader DePuy Synthes 1301 Goshen Parkway West Chester, PA 19380 Phone: 610-719-1268 Email: rreiter@its.jnj.com Alternate Contact: Elizabeth Jacobs Regulatory Affairs Project Leader DePuy Synthes 1301 Goshen Parkway West Chester, PA 19380 Phone: (610) 719-5768 Email: ejacob10@its.jnj.com ### 1.2. Device Trade Name: DePuy Synthes Maxillofacial Portfolio - MR Conditional Name of Device: DePuy Synthes Low Profile Neuro System - 3 mm Screws Classification Name(s): Screw, Fixation, Intraosseous Regulatory Class: Class II; 872.4880 ## Product Code(s): DZL #### 1.3. Predicate Device K031807 Synthes Low Profile Neuro System - 3 mm Screws #### Device Description 1.4. This document is regarding the DePuy Synthes Low Profile Neuro System - 3 mm Screws, which are a subset of the DePuy Synthes Maxillofacial Portfolio – MR Conditional. Synthes ø1.6 mm Low Profile Neuro System self-drilling, self-tapping, and ø1.9 mm emergency self-tapping screws in 3 mm lengths are to be added to the system. The devices in scope of K183113 are being reviewed for MR Conditional labeling for maxillofacial indications. {27}------------------------------------------------ Image /page/27/Picture/0 description: The image shows the logo for DePuy Synthes, which is part of the Johnson & Johnson family of companies. The logo includes a symbol of two overlapping circles in gold, followed by the company name in blue. Below the company name, there is a tagline in gold that says "People inspired". The text "PART OF THE Johnson&Johnson FAMILY OF COMPANIES" is in a smaller font size and is located below the company name. The DePuy Synthes Low Profile Neuro System -3 mm Screws is intended for use in selective trauma of the midface and maxillofacial skeleton; maxillofacial surgery; reconstructive procedures; and selective orthognathic surgery of the maxilla and chin. ### Substantial Equivalence 1.6. The purpose of this submission is to add MR Conditional information to the device labeling for the DePuy Synthes Low Profile Neuro System - 3 mm Screws. Changes in the Indications for Use Statement are to remove language not specific to maxillofacial surgeries, as these (e.g., craniofacial) indications are not reviewed by the Dental Review Panel. The technological characteristics of the devices remains unchanged. The device name has been updated to reflect the current company name, DePuy Synthes. An indications for use comparison table is provided below. | K183113 | K031807 | |-------------------------------------------------------------------------------------------|------------------------------------------------| | The DePuy Synthes Low Profile Neuro System - Synthes Low Profile Neuro System is intended | | | 3 mm Screws is intended for use in selective | for use in selective trauma of the midface and | | trauma of the midface and | craniofacial skeleton; craniofacial surgery; | | maxillofacial skeleton; maxillofacial surgery; | reconstructive procedures; and selective | | reconstructive procedures; and selective | orthognathic surgery of the maxilla and chin. | | orthognathic surgery of the maxilla and chin. | | ### Non-Clinical Testing Summary 1.7. Non-clinical testing is provided to support the conditional safety of the DePuy Synthes Low Profile Neuro System - 3 mm Screws in the MR environment including assessment of magnetically induced displacement force (ASTM F2052-14) and torque (ASTM F2213-06), radio frequency (RF) heating (ASTM F2182-11a and DUKE model), and image artifacts (ASTM F2119-07). The DUKE model places devices in the clinically relevant anatomic position. The DUKE results will be used for labeling of RF heating. {28}------------------------------------------------ Image /page/28/Picture/0 description: The image shows the logo for DePuy Synthes, which is part of the Johnson & Johnson family of companies. The logo features a stylized symbol to the left of the company name, "DePuy Synthes," which is written in a bold, blue font. To the right of the company name, the phrase "People inspired" is written in a cursive, gold font. Below the company name, there is a smaller line of text that reads "PART OF THE Johnson & Johnson FAMILY OF COMPANIES." ### 510(k) Summarv 1. Date Prepared: March 7, 2019 ### 1.1. Submitter Primary Contact: Rebecca Reiter Regulatory Affairs Project Leader DePuy Synthes 1301 Goshen Parkway West Chester, PA 19380 Phone: 610-719-1268 Email: rreiter@its.jnj.com Alternate Contact: Elizabeth Jacobs Regulatory Affairs Project Leader DePuy Synthes 1301 Goshen Parkway West Chester, PA 19380 Phone: (610) 719-5768 Email: ejacob10@its.jnj.com ### 1.2. Device Trade Name: DePuy Synthes Maxillofacial Portfolio - MR Conditional Name of Device: DePuy Synthes External Midface Distractor Classification Name(s): External Mandibular Fixator And/Or Distractor Regulatory Class: Class II; 872.4760 Product Code(s): MQN #### 1.3. Predicate Device K040083 Synthes External Midface Distractor #### Device Description 1.4. This document is regarding the DePuy Synthes External Midface Distractor, which are a subset of the DePuy Synthes Maxillofacial Portfolio - MR Conditional. The DePuy Synthes External Midface Distractor is an external distraction osteogenesis device that attaches to the midface and is used to gradually lengthen the midface at the LeFort I, II, and III levels. The device consists of an external headframe, a central adjustment mechanism, a veridical central rod, horizontal crosspieces containing distraction screws, and separate footplates assemblies that attach to the zygoma and maxilla. The devices in scope of K183113 are being reviewed for MR Conditional labeling for maxillofacial indications. {29}------------------------------------------------ Image /page/29/Picture/0 description: The image shows the logo for DePuy Synthes, which is part of the Johnson & Johnson family of companies. The logo features a stylized symbol resembling interconnected circles in a gold color, followed by the company name "DePuy Synthes" in a bold, dark blue font. To the right of the company name, the phrase "People inspired" is written in an elegant, cursive font, also in a gold color. The DePuy Synthes External Midface Distractor is intended for use in maxillofacial surgery, reconstructive procedures, and selective orthognathic surgery of the maxilla. Specifically, it is intended for distraction of the maxilla utilizing a LeFort I osteotomy and/or the midface utilizing a LeFort II or III osteotomy in adult and pediatric populations where gradual bone distraction is required. ### Substantial Equivalence 1.6. The purpose of this submission is to add MR Conditional information to the device labeling for the DePuy Synthes External Midface Distractor. Changes in the Indications for Use Statement are to remove language not specific to maxillofacial surgeries, as these (e.g., craniofacial) indications are not reviewed by the Dental Review Panel. The technological characteristics of the devices remains unchanged. The device name has been updated to reflect the current company name, DePuy Synthes. An indications for use comparison table is provided below. | K183113 | K040083 | |----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | The DePuy Synthes External Midface<br>Distractor is intended for use in maxillofacial<br>surgery, reconstructive procedures, and<br>selective orthognathic surgery of the maxilla.<br>Specifically, it is intended for distraction of the<br>maxilla utilizing a LeFort I osteotomy and/<br>or the midface utilizing a LeFort II or III<br>osteotomy in adult and pediatric populations<br>where gradual bone distraction is required. | The Synthes External Midface Distractor is<br>intended for use in craniofacial surgery,<br>reconstructive procedures, and selective<br>orthognathic surgery of the maxilla.<br>Specifically, it is intended for distraction of the<br>maxilla utilizing a LeFort I osteotomy, the<br>midface utilizing a LeFort II or III osteotomy,<br>and / or the cranium utilizing a monobloc<br>osteotomy in adult and pediatric populations<br>where gradual bone distraction is required. | {30}------------------------------------------------ Image /page/30/Picture/0 description: The image shows the logo for DePuy Synthes, which is part of the Johnson & Johnson family of companies. The logo features a stylized eye symbol in gold, followed by the company name in blue, and the tagline "People inspired" in a cursive font. The text "PART OF THE Johnson & Johnson FAMILY OF COMPANIES" is located below the company name in a smaller font. ### Non-Clinical Testing Summary 1.7. Non-clinical testing is provided to support the conditional safety of the DePuy Synthes External Midface Distractor in the MR environment including assessment of magnetically induced displacement force (ASTM F2052-14) and torque (ASTM F2213-06), radio frequency (RF) heating (ASTM F2182-11a and DUKE model), and image artifacts (ASTM F2119-07). The DUKE model places devices in the clinically relevant anatomic position. The DUKE results will be used for labeling of RF heating. {31}------------------------------------------------ Image /page/31/Picture/0 description: The image shows the logo for DePuy Synthes, which is part of the Johnson & Johnson family of companies. The logo features a stylized symbol to the left of the company name, "DePuy Synthes," which is written in a bold, blue font. To the right of the company name, the phrase "People inspired" is written in a cursive, gold font. Below the company name, there is a smaller line of text that reads "PART OF THE Johnson & Johnson FAMILY OF COMPANIES." ### 510(k) Summary 1. Date Prepared: March 7, 2019 ### 1.1 Submitter Primary Contact: Rebecca Reiter Regulatory Affairs Project Leader DePuy Synthes 1301 Goshen Parkway West Chester, PA 19380 Phone: 610-719-1268 Email: rreiter@its.jnj.com Alternate Contact: Elizabeth Jacobs Regulatory Affairs Project Leader DePuy Synthes 1301 Goshen Parkway West Chester, PA 19380 Phone: (610) 719-5768 Email: ejacob10@its.jnj.com ### 1.2 Device Trade Name: DePuy Synthes Maxillofacial Portfolio - MR Conditional Name of Device: DePuy Synthes 1.0/1.2 mm Craniofacial Screws Classification Name(s): Screw, Fixation, Intraosseous Regulatory Class: Class II; 872.4880 Product Code(s): DZL #### 1.3 Predicate Device K041887 Synthes 1.0/1.2 mm Craniofacial Screws #### 1.4 Device Description This document is regarding the DePuy Synthes 1.0/1.2 mm Craniofacial Screws, which are a subset of the DePuy Synthes Maxillofacial Portfolio - MR Conditional. The DePuy Synthes 1.0/1.2 mm Craniofacial Screws are either self-drilling or self tapping, have a flat head profile with rounded edges with a cruciform recess, and are available in various lengths. The devices in scope of K183113 are being reviewed for MR Conditional labeling for maxillofacial indications. {32}------------------------------------------------ Image /page/32/Picture/0 description: The image shows the logo for DePuy Synthes, which is part of the Johnson & Johnson family of companies. The logo includes a symbol that looks like two overlapping circles, followed by the company name in blue, and the tagline "People inspired" in gold. Below the company name, it says "PART OF THE Johnson & Johnson FAMILY OF COMPANIES" in smaller letters. The DePuy Synthes 1.0/1.2 mm Craniofacial Screws are intended for use as follows: General Indications: - Maxillofacial surgery ### Substantial Equivalence 1.6 The purpose of this submission is to add MR Conditional information to the device labeling for the DePuy Synthes 1.0/1.2 mm Craniofacial Screws. Changes in the Indications for Use Statement are to remove language not specific to maxillofacial surgeries, as these (e.g., craniofacial) indications are not reviewed by the Dental Review Panel. The technological characteristics of the devices remains unchanged. The device name has been updated to reflect the current company name, DePuy Synthes. An indications for use comparison table is provided below. | K183113 | K041887 | |-------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | The DePuy Synthes 1.0/1.2 mm Craniofacial | The Synthes 1.0/1.2 mm Craniofacial Screws | | Screws are intended for use as follows: | are intended for use as follows: | | General Indications:<br>• Maxillofacial surgery | Specific Indications:<br>• Nasoethmoidal fractures<br>• Infraorbital area fractures<br>• Frontal sinus wall fractures<br>• Infant craniofacial surgery<br>General Indications:<br>• Maxillofacial surgery | {33}------------------------------------------------ Image /page/33/Picture/0 description: The image shows the logo for DePuy Synthes, which is part of the Johnson & Johnson family of companies. The logo consists of a symbol resembling two overlapping circles in a light brown color, followed by the name "DePuy Synthes" in a dark blue, sans-serif font. Below the name, there is a smaller text indicating that it is "PART OF THE Johnson & Johnson FAMILY OF COMPANIES". ### Non-Clinical Testing Summary 1.7 Non-clinical testing is provided to support the conditional safety of the DePuy Synthes 1.0/1.2 mm Craniofacial Screws in the MR environment including assessment of magnetically induced displacement force (ASTM F2052-14) and torque (ASTM F2213-06), radio frequency (RF) heating (ASTM F2182-11a and DUKE model), and image artifacts (ASTM F2119-07). The DUKE model places devices in the clinically relevant anatomic position. The DUKE results will be used for labeling of RF heating. {34}------------------------------------------------ Image /page/34/Picture/0 description: The image shows the logo for DePuy Synthes, which is part of the Johnson & Johnson family of companies. The logo features a stylized symbol to the left of the text "DePuy Synthes" in a dark blue font. To the right of the company name, the phrase "People inspired" is written in a cursive, gold-colored font. Below the company name, there is smaller text indicating that DePuy Synthes is part of the Johnson & Johnson family of companies. ### 510(k) Summary 1. Date Prepared: March 7, 2019 ### 1.1. Submitter Primary Contact: Rebecca Reiter Regulatory Affairs Project Leader DePuy Synthes 1301 Goshen Parkway West Chester, PA 19380 Phone: 610-719-1268 Email: rreiter@its.jnj.com Alternate Contact: Elizabeth Jacobs Regulatory Affairs Project Leader DePuy Synthes 1301 Goshen Parkway West Chester, PA 19380 Phone: (610) 719-5768 Email: ejacob10@its.jnj.com ### 1.2. Device Trade Name: DePuy Synthes Maxillofacial Portfolio - MR Conditional Name of Device: DePuy Synthes Alveolar Distractor Classification Name(s): External Mandibular Fixator And/Or Distractor Regulatory Class: Class II; 872.4760 Product Code(s): MQN #### 1.3. Predicate Device K043555 Synthes Alveolar Distractor #### Device Description 1.4. This document is regarding the DePuy Synthes Alveolar Distractor, which are a subset of the DePuy Synthes Maxillofacial Portfolio – MR Conditional. The DePuy Synthes Alveolar Distractor is an extraosseous distraction device consisting of a distractor body, a transport plate, a base plate, and a vector control mechanism. It is intended to be placed submucosally, with the base plate fastened to the stationary segment of the mandible or maxilla and the transport plate fastened to the mobile bone segment. The plates are fixed to the bone using 1.5 mm cortex screws. The devices in scope of K183113 are being reviewed for MR Conditional labeling for maxillofacial indications. {35}------------------------------------------------ Image /page/35/Picture/0 description: The image shows the logo for DePuy Synthes, which is part of the Johnson & Johnson family of companies. The logo includes a symbol of two overlapping circles in gold, followed by the company name in blue. Below the company name, it says "Part of the Johnson & Johnson family of companies" in a smaller font. To the right of the company name, the words "People inspired" are written in a cursive gold font. The DePuy Synthes Alveolar Distractor is intended for vertical bone lengthening of the alveolar ridge in the mandible and the maxilla where gradual bone distraction is required, including deficiency in bone height as a result of trauma, resorption after dental extraction, periodontal disease, tumor resection, and congenital deformity. ### 1.6. Substantial Equivalence The purpose of this submission is to add MR Conditional information to the device labeling for the DePuy Synthes Alveolar Distractor. The intended use and technological characteristics of the devices remains unchanged. The device name has been updated to reflect the current company name, DePuy Synthes. An indications for use comparison table is provided below. | K183113 | K043555 | |--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | The DePuy Synthes Alveolar Distractor is intended for vertical bone lengthening of the alveolar ridge in the mandible and the maxilla where gradual bone distraction is required, including deficiency in bone height as a result of trauma, resorption after dental extraction, periodontal disease, tumor resection, and congenital deformity. | The Synthes Alveolar Distractor is intended for vertical bone lengthening of the alveolar ridge in the mandible and the maxilla where gradual bone distraction is required, including deficiency in bone height as a result of trauma, resorption after dental extraction, periodontal disease, tumor resection, and congenital deformity. | ### Non-Clinical Testing Summary 1.7. Non-clinical testing is provided to support the conditional safety of the DePuy Synthes Alveolar Distractor in the MR environment including assessment of magnetically induced displacement force (ASTM F2052-14) and torque (ASTM F2213-06), radio frequency (RF) heating (ASTM F2182-11a and DUKE model), and image artifacts (ASTM F2119-07). The DUKE model places devices in the clinically relevant anatomic position. The DUKE results will be used for labeling of RF heating. {36}------------------------------------------------ Image /page/36/Picture/0 description: The image shows the logo for DePuy Synthes, which is part of the Johnson & Johnson family of companies. The logo includes a symbol that looks like two overlapping circles, followed by the company name in blue, and the tagline "People inspired" in gold. The text "PART OF THE Johnson+Johnson FAMILY OF COMPANIES" is written in a smaller font below the company name. ### 510(k) Summary 1. Date Prepared: March 7, 2019 ### 1.1. Submitter Primary Contact: Rebecca Reiter Regulatory Affairs Project Leader DePuy Synthes 1301 Goshen Parkway West Chester, PA 19380 Phone: 610-719-1268 Email: rreiter@its.jnj.com ## Alternate Contact: Elizabeth Jacobs Regulatory Affairs Project Leader DePuy Synthes 1301 Goshen Parkway West Chester, PA 19380 Phone: (610) 719-5768 Email: ejacob10@its.jnj.com ### 1.2. Device Trade Name: DePuy Synthes Maxillofacial Portfolio - MR Conditional Name of Device: DePuy Synthes Craniomaxillofacial Distraction System (CMF Distraction System) Classification Name(s): External Mandibular Fixator And/Or Distractor Regulatory Class: Class II; 872.4760 Product Code(s): MQN #### 1.3. Predicate Device K060138 Synthes Craniomaxillofacial Distraction System (CMF Distraction System) #### Device Descrip…
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