DePuy Synthes Trauma Orthopedic Plates and Screws

K180310 · Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc. · HRS · Nov 1, 2018 · Orthopedic

Device Facts

Record IDK180310
Device NameDePuy Synthes Trauma Orthopedic Plates and Screws
ApplicantSynthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.
Product CodeHRS · Orthopedic
Decision DateNov 1, 2018
DecisionSESE
Submission TypeTraditional
Regulation21 CFR 888.3030
Device ClassClass 2
AttributesTherapeutic

Intended Use

The DePuy Synthes Reconstructive Plates 'Y' Plates are indicated for pelvic and acetabular reconstructive surgery and the reduction of fractures in the distal humerus, the clavicle, and the scapula.

Device Story

Metallic bone fixation plates and screws; used for fracture reduction, osteotomies, and non-union treatment in various long bones (humerus, femur, tibia, radius, ulna, fibula, clavicle, scapula, pelvis). Plates feature locking/compression holes for stable fixation; some models include variable angle locking or cannulated designs. Operated by surgeons in clinical settings. Input: patient anatomy/fracture pattern; Output: rigid mechanical stabilization of bone segments. Benefits: promotes bone healing, restores alignment, and provides stable fixation in osteopenic bone. This submission updates labeling to include MR Conditional status based on non-clinical testing.

Clinical Evidence

Bench testing only. No clinical data provided. Testing included assessment of magnetically induced displacement force, torque, RF heating, and image artifacts per ASTM standards.

Technological Characteristics

Metallic bone fixation plates and screws (stainless steel or commercially pure titanium). Features include locking/compression holes, limited contact profiles, and anatomical contouring. MR Conditional status supported by non-clinical testing.

Indications for Use

Indicated for pelvic/acetabular reconstructive surgery and fracture reduction of distal humerus, clavicle, and scapula.

Regulatory Classification

Identification

Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.

Predicate Devices

Related Devices

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains two logos. The logo on the left is the Department of Health & Human Services logo. The logo on the right is the FDA logo, which is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue. Synthes (USA) Products LLC/DePuy Orthopaedics Inc Jeffrey Krawiec Regulatory Affairs Specialist 1301 Goshen Parkway West Chester, Pennsylvania 19380 November 1, 2018 ### Re: K180310 Trade/Device Name: DePuy Synthes Trauma Orthopedic Plates and Screws Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances And Accessories Regulatory Class: Class II Product Code: HRS, HWC, KTT, KTW, LXT Dated: September 28, 2018 Received: October 1, 2018 Dear Jeffrey Krawiec: 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. 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 {1}------------------------------------------------ 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 (QS) 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 medical devices and radiation-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, Digitally signed Jesse by Jesse Muir -S Date: 2018.11.01 Muir -S 18:42:03 -04'00' For: Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below. 510(k) Number (if known) K180310 Device Name DePuy Synthes Reconstructive Plates 'Y' Plates - MR Conditional Indications for Use (Describe) The DePuy Synthes Reconstructive Plates 'Y' Plates are indicated for pelvic and acetabular reconstructive surgery and the reduction of fractures in the distal humerus, the clavicle, and the scapula. 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 {3}------------------------------------------------ Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below. 510(k) Number (if known) K180310 Device Name DePuy Synthes Anatomical Locking Plate System - MR Conditional Indications for Use (Describe) The DePuy Synthes Anatomical Locking Plate System is indicated to treat fractures (including but not limited to) the radius, ulna, humerus, tibia, fibula, femur. 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 {4}------------------------------------------------ Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below. 510(k) Number (if known) K180310 Device Name DePuy Synthes Cannulated Angle Blade Plate (CABP) System - MR Conditional #### Indications for Use (Describe) The DePuy Synthes CABP System is a plate and screw system intended to treat fractures of the proximal humerus and distal tibia. Proximal humerus fractures include two-part greater tubercle fracture dislocations. two-part surgical neck fractures and fracture dislocations, three-part fracture dislocations, fractures in osteopenic bone, and nonunions and malunions. Distal tibia fractures include acute fractures in osteopenic bone, and nonunions and malunions. | 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 {5}------------------------------------------------ Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below. 510(k) Number (if known) K180310 Device Name DePuy Synthes 3.5 mm 90° Cannulated Limited Contact-Angled Blade Plates – MR Conditional Indications for Use (Describe) The DePuy Synthes 3.5 mm 90° Cannulated Limited Contact Angled Blade Plates are intended for the fixation of fractures and non-unions of the proximal humerus and distal tibia. 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 {6}------------------------------------------------ Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below. 510(k) Number (if known) K180310 Device Name DePuy Synthes Large Fragment Dynamic Compression Locking (DCL) System - MR Conditional Indications for Use (Describe) The DePuy Synthes Large Fragment DCL is intended for fixation of various lones, such as the humerus, femur and tibia. Also for use in fixation of osteopenic bone and fixation of non-unions or malunions. 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 {7}------------------------------------------------ Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below. 510(k) Number (if known) K180310 Device Name DePuy Synthes Large Fragment Locking Compression Plate (LCP) System - T Plate - MR Conditional Indications for Use (Describe) The DePuy Synthes Large Fragment Locking Compression Plate (LCP) System - T Plate is intended to buttress metaphyseal fractures of the proximal humerus, medial tibia. Also for use in fixation of osteopenic bone and fixation of non-unions and malunions. | 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 {8}------------------------------------------------ Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below. 510(k) Number (if known) K180310 Device Name DePuy Synthes Curved Reconstruction Plate - MR Conditional Indications for Use (Describe) The DePuy Synthes Curved Reconstruction Plate is intended for fixation of fractures, and non-unions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, distal tibia, particularly in osteopenic bone as a part of the DePuy Synthes Small Fragment DCL System. | Type of Use (Select one or both, as applicable) | | |------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------| | <div style="display:flex; align-items:center;"><span style="font-size:16px;">☒</span> Prescription Use (Part 21 CFR 801 Subpart D)</div> | <div style="display:flex; align-items:center;"><span style="font-size:16px;">☐</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 {9}------------------------------------------------ Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below. 510(k) Number (if known) K180310 Device Name DePuy Synthes One-Third Tubular Dynamic Compression Locking (DCL) Plate - MR Conditional Indications for Use (Describe) The DePuy Synthes One-Third Tubular Plate is intended for fixation of fractures, and non-unions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, distal tibia, particularly in osteopenic bone as a part of the DePuy Synthes Small Fragment DCL System. | Type of Use (Select one or both, as applicable) | | |--------------------------------------------------------------------------|-------------------------------------------------------------------------| | <div> <span>☑ Prescription Use (Part 21 CFR 801 Subpart D)</span> </div> | <div> <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 {10}------------------------------------------------ Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below. 510(k) Number (if known) K180310 Device Name DePuy Synthes LCP Proximal Humerus Plate - MR Conditional Indications for Use (Describe) The DePuy Synthes LCP Proximal Humerus Plate is indicated for fracture dislocations, osteotomies, and non-unions of the proximal humerus, particularly in osteopenic 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 {11}------------------------------------------------ Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below. 510(k) Number (if known) K180310 Device Name DePuy Synthes Pilon Plate - MR Conditional Indications for Use (Describe) The DePuy Synthes Pilon Plate is intended for fixation of complex intra- and extra-articular fractures of the distal tibia. 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 {12}------------------------------------------------ Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below. 510(k) Number (if known) K180310 Device Name DePuy Synthes TomoFix Osteotomy System - MR Conditional Indications for Use (Describe) DePuy Synthes TomoFix Osteotomy System is intended for open and closed wedge osteotomies of the medial proximal tibia, lateral proximal tibia and lateral distal femur, treatment of bone and joint deformities, and malalignment caused by injury or disease such as osteoarthritis. | 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 {13}------------------------------------------------ Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below. 510(k) Number (if known) K180310 Device Name DePuy Synthes 3.5 mm Broad LCP & 4.5 mm LCP Distal Humerus Plate – MR Conditional Indications for Use (Describe) The DePuy Synthes 3.5 mm Broad LCP & 4.5 mm LCP Distal Humerus Plates are indicated for fractures of the distal humerus. 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 {14}------------------------------------------------ Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below. 510(k) Number (if known) K180310 Device Name DePuy Synthes Clavicle Hook Plate - MR Conditional Indications for Use (Describe) The DePuy Synthes Clavicle Hook Plate is intended for fixation of lateral clavicle fractures and dislocations of the acromioclavicular joint. 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 {15}------------------------------------------------ Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below. 510(k) Number (if known) K180310 Device Name DePuy Synthes 3.5 / 4.5 mm LCP® Metaphyseal Plates - MR Conditional Indications for Use (Describe) The DePuy Synthes 3.5 / 4.5 LCP Metaphyseal Plate is intended for fixation of various long bones, excluding the femur. It is also for use in fixation of osteopenic bone and fixation of nonunions or malunions. 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 {16}------------------------------------------------ Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below. 510(k) Number (if known) K180310 Device Name DePuy Synthes 3.5 mm LCP Distal Humerus System - MR Conditional Indications for Use (Describe) The DePuy Synthes 3.5 mm LCP Distal Humerus System is indicated for intraarticular fractures of the distal humerus, commninuted supra-condylar fractures, osteotomies, and non-unions of the distal humerus. 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 {17}------------------------------------------------ Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below. 510(k) Number (if known) K180310 Device Name DePuy Synthes LCP® Proximal Humerus Plates, Long - MR Conditional Indications for Use (Describe) The DePuy Synthes LCP Proximal Humerus Plate, Long is indicated for fractures and fracture dislocations, osteotomies, and non-unions of the proximal humerus, particularly in osteopenic 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}------------------------------------------------ Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below. 510(k) Number (if known) K180310 Device Name DePuy Synthes LCP® Curved Plates - MR Conditional Indications for Use (Describe) The DePuy Synthes Curved Broad Plates are intended for fixation of various long bones, such as the humerus, femur, and tibia. They are also for use in fixation of peri-prosthetic fractures, osteopenic bone and non-unions or malunions. The DePuy Synthes Curved Condylar Plates are intended for buttressing multifragmentary distal femur fractures. including: supracondylar, intra-articular condylar fractures, peri-prosthetic fractures and fractures in normal or osteopenic bone, nonunions/malunions, and osteotomies of the femur. 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 {19}------------------------------------------------ Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below. 510(k) Number (if known) K180310 Device Name DePuy Synthes Low Profile Reconstruction Plates - MR Conditional Indications for Use (Describe) The DePuy Synthes Low Profile Reconstruction Plates are intended for pelvic and acetabular reconstruction and fixation of fractures of the distal humerus, clavicle, and scapula. | 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 {20}------------------------------------------------ Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below. 510(k) Number (if known) K180310 #### Device Name DePuy Synthes 3.5 mm Spring Plate - MR Conditional Indications for Use (Describe) The DePuy Synthes 3.5 mm Spring Plate is intended for pelvic and acetabular reconstructive surgery and fracture fixation of the distal fibula. 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 {21}------------------------------------------------ Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below. 510(k) Number (if known) K180310 Device Name DePuy Synthes 3.5 mm LCP Hook Plate - MR Conditional Indications for Use (Describe) The DePuy Synthes 3.5 mm LCP Hook Plate is indicated for fractures and non-unions of small bones including the ulna, radius, tibia and fibula, particularly in osteopenic 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 {22}------------------------------------------------ Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below. 510(k) Number (if known) K180310 Device Name DePuy Synthes 3.5mm LCP Periarticular Proximal Humerus Plates - MR Conditional Indications for Use (Describe) The DePuy Synthes 3.5 mm LCP Periarticular Proximal Humerus Plates are indicated for fracture dislocations, osteotomies, and non-unions of the proximal humerus, particularly in osteopenic 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 {23}------------------------------------------------ Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below. #### 510(k) Number (if known) K180310 #### Device Name DePuy Synthes 3.5 mm and 4.5 mm Locking Compression Plate (LCP) System with Expanded Indications - MR Conditional Indications for Use (Describe) The DePuy Synthes 3.5 mm Locking Compression Plate (LCP) System: The DePuy Synthes 3.5 mm LCP is indicated for fixation of fractures, osteotomies and non-unions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, distal tibia, fibularly in osteopenic bone for adult patients, These plates are also indicated for fracture fixation of diaphyseal areas of long bones in pediatric patients. The DePuy Synthes 4.5 mm Locking Compression Plate (LCP) System: The DePuy Synthes 4.5 mm LCP is indicated for fixation of various long bones, such as the humerus, femur and tibia and for use in fixation of peri-prosthetic fractures, osteopenic bone and fixation of non-unions in adult patients. These plates are also indicated for fracture fixation of diaphyseal areas of long bones in pediatric patients. | Type of Use (Select one or both, as applicable) | | |------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--| | <span style="font-size: 10pt;"> <span style="font-family: Arial;"> <span style="font-weight: bold;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </span> | | | <span style="font-size: 10pt;"> <span style="font-family: Arial;"> <span style="font-weight: normal;">☐</span> 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 {24}------------------------------------------------ Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below. 510(k) Number (if known) K180310 Device Name DePuy Synthes 3.5 mm Locking Attachment Plates - MR Conditional Indications for Use (Describe) The DePuy Synthes 3.5mm Locking Attachment Plate is intended for use with DePuy Synthes LCP plates to augment the stabilization of fractures, including periprosthetic fractures in the presence of intramedullary implants, in the femur, tibia and humerus, particularly in osteopenic bone. 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 {25}------------------------------------------------ Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below. #### 510(k) Number (if known) K180310 Device Name DePuy Synthes 3.5 mm and 4.5 mm Curved Narrow and Broad Locking Compression Plates (LCP) - MR Conditional #### Indications for Use (Describe) The DePuy Synthes 3.5 mm Curved Narrow and Broad LCP Plates are intended for fixation of fractures and non-unions of clavicle, scapula, olecranon, humerus, radius, pelvis, distal tibia and fibularly in osteopenic bone for adult patients. The DePuy Synthes 4.5 mm Curved Narrow and Broad LCP Plates are intended for fixation of various long bones, such as the humerus, femur, and tibia. They are also for use in fixation of periprosthetic fractures, osteopenic bone, and nonunions or malunions in adult patients. The DePuy Synthes 3.5 mm and 4.5 mm Curved Narrow and Broad LCP Plates are also indicated for fracture fixation of diaphyseal and metaphyseal areas of long bones in pediatric patients. 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 {26}------------------------------------------------ Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below. 510(k) Number (if known) K180310 Device Name DePuy Synthes 2.7 mm / 3.5 mm VA-LCP Anterior Clavicle Plate System - MR Conditional Indications for Use (Describe) The DePuy Synthes 2.7 mm / 3.5 mm VA-LCP Anterior Clavicle Plate System is indicated for fixatures, malunions, non-unions, and osteotomies of the clavicle in adults, and in both adolescents (12-18 years) and transitional adolescents (18-21 years), in which the clavicular growth plates have fused or in which the growth plates will not be crossed by the plate system. | Type of Use (Select one or both, as applicable) | | |----------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------| | <span style="font-family: DejaVu Sans, sans-serif">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="font-family: DejaVu Sans, sans-serif">☐</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 {27}------------------------------------------------ Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below. 510(k) Number (if known) K180310 Device Name DePuy Synthes 3.5 mm LCP Clavicle Plate System - MR Conditional Indications for Use (Describe) The DePuy Synthes 3.5 mm LCP Clavicle Plate System is indicated for fixation of fractures, non-unions, and osteotomies of the clavicle in adults, and in both adolescents (12-18 years) and transitional adolescents (18-21 years), in which clavicular growth plates have fused or in which the growth plates will not be crossed by the plate system. | 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 {28}------------------------------------------------ Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below. 510(k) Number (if known) K180310 Device Name DePuy Synthes Variable Angle LCP Elbow System - MR Conditional #### Indications for Use (Describe) The DePuy Synthes Variable Angle LCP Elbow System is intended for fixation of fractures of the distal humerus, olecranon and ulna in adults and adolescents (12-21) in which the growth plates have fused or in which the growth plates will not be crossed by the plate system. Specifically, - Distal humerus plates are indicated for intra-articular fractures, comminuted supracondylar fractures, malunions and non-unions of the distal humerus. - Olecranon and Proximal ulna plates are indicated for fractures, malunions and non-unions of the olecranon and proximal ulna. | 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 {29}------------------------------------------------ Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below. #### 510(k) Number (if known) K180310 Device Name DePuy Synthes Variable Angle LCP Elbow System (Medial and Posterolateral Distal Humerus Plates) – MR Conditional Indications for Use (Describe) The DePuy Synthes Variable Angle LCP Elbow System is intended for fixation of fractures of the distal humerus, olecranon and ulna in adults and adolescents (12-2 1) in which the growth plates have fused. Specifically, · Distal humerus plates are indicated for intra-articular fractures, comminuted supracondylar fractures. malunions and non-unions of the distal humerus. · Olecranon and Proximal ulna plates are indicated for fractures, malunions and non-unions of the olecranon and proximal ulna. 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 {30}------------------------------------------------ Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below. 510(k) Number (if known) K180310 Device Name DePuy Synthes TOMOFIX Osteotomy System - MR Conditional Indications for Use (Describe) The DePuy Synthes TOMOFIX Osteotomy System is intended for osteotomies, treatment of bone and joint deformities, fixation of fractures, and malalignment caused by injury or disease, such as osteoarthritis, of the distal femur and proximal tibia. Specifically, -The TOMOFIX Medial Proximal Tibia Plates are indicated for open- and close-wedge osteotomies fixation of fractures, and malalignment caused by injury or disease, such as osteoarthritis, of the medial proximal tibia -The TOMOFIX Lateral Proximal Tibia Plates are indicated for open- and closed-wedge osteotomies fixation of fractures. and malalignment caused by injury or disease, such as osteoarthritis, of the lateral proximal tibia -The TOMOFIX Lateral Distal Femur Plates are indicated for open- and closed-wedge osteotomies fixation of fractures, and malalignment caused by injury or disease, such as osteoarthritis, of the lateral distal femur -The TOMOFIX Medial Distal Femur Plates are indicated for closed-wedge osteotomies fixation of fractures, and malalignment caused by injury or disease, such as osteoarthritis, of the medial distal femur | Type of Use (Select one or both, as applicable) | | |---------------------------------------------------------------------------------------------------------------------|--| | <div> <span> <input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | | | <div> <span> <input type="checkbox"/> 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 {31}------------------------------------------------ Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below. 510(k) Number (if known) K180310 Device Name DePuy Synthes 2.4/2.7mm VA LCP Two-Column Volar Distal Radius Plate, Extra-Long - MR Conditional Indications for Use (Describe) The DePuy Synthes 2.4/2.7 mm VA-LCP Two-Column Volar Distal Radius Plate, Extra-Long is intended for intra-and extra-articular fractures, osteotomies, nonunions of the distal radius, with or without extension into the radial diaphysis in adults and adolescents (12-21) where the growth plates have fused or will not be crossed, and the following adolescent distal radius fractures: - Intra-articular fractures exiting the epiphysis - Intra-articular fractures exiting the metaphysis - Physeal crush injuries - Any injuries which cause growth arrest to the distal radius | 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 {32}------------------------------------------------ Image /page/32/Picture/1 description: The image displays the logo for DePuy Synthes, a company that is part of the Johnson & Johnson family of companies. The logo features a golden circular design on the left, followed by the company name "DePuy Synthes" in blue. To the right of the company name, the phrase "People inspired" is written in a cursive font. The text "PART OF THE Johnson-Johnson FAMILY OF COMPANIES" is located beneath the company name in a smaller font size. Date Prepared: October 29, 2018 ### 1.1 Submitter ### Primary Contact: Jeffrey Krawiec Regulatory Affairs Specialist DePuy Synthes 1301 Goshen Parkway West Chester, PA 19380 Phone: (610) 719-5434 Jkrawiec@its.jnj.com ### Alternate Contact: Thomas Shea Manager, Regulatory Affairs DePuy Synthes 1301 Goshen Parkway West Chester, PA 19380 Phone: (610) 719-5679 tshea@its.jnj.com ### 1.2. Device Name of Device: DePuy Synthes Reconstructive Plates 'Y' Plates – MR Conditional Classification Name(s): Appliance, Fixation, Nail/Blade/Plate Combination, Single Component Regulatory Class: Class II, §888.3030 Product Code(s): KTW 1.3. Predicate Device K792291 Synthes Reconstructive Plates 'Y' Plates ## 1.4. Device Description The 3.5 mm Reconstruction Plate is available in multiple lengths. It has a smooth underside, is notched between the screw holes and can be adjusted (contoured) in three dimensions. The screw holes are designed to provide limited bidirectional compression of the fracture via the tapered entrance of the hole, and accept 3.5 mm cortex screws The 4.5 mm Reconstruction Plate has a smooth underside, is notched between the screw holes and can be adjusted (contoured) in three dimensions. The oval holes are designed to provide limited bidirectional compression of the fracture via the tapered entrance of the hole which allows 25° longitudinal and 7° lateral angulation of screws. It is available in multiple lengths and accepts 4.5 mm cortex and 6.5 mm cancellous screws. {33}------------------------------------------------ Image /page/33/Picture/1 description: The image shows the logo for DePuy Synthes, a company that is part of the Johnson & Johnson family of companies. The logo consists of a symbol that looks like two intersecting circles, followed by the company name in blue, and the tagline "People inspired" in a light cursive font. Below the company name, there is a smaller text that reads "PART OF THE Johnson & Johnson FAMILY OF COMPANIES". The 3.5 mm Curved Reconstruction Plate is available in multiple lengths. It has a smooth underside and is notched between screw holes and can be adjusted (contoured) in three dimensions. The screw holes are designed to provide limited bidirectional compression of the fracture via the tapered entrance of the hole and accept 3.5 mm cortex screws. ### 1.5. Intended Use The DePuy Synthes Reconstructive Plates 'Y' Plates are indicated for pelvic and acetabular reconstructive surgery and the reduction of fractures in the distal humerus, the clavicle, and the scapula. ## 1.6. Substantial Equivalence The purpose of this submission is to add MR Conditional information to the device labeling for the DePuy Synthes Reconstructive Plates 'Y' Plates. The intended use and technological characteristics of the devices remains unchanged. Non-clinical testing is provided to support the conditional safety of the DePuy Synthes Reconstructive Plates 'Y' Plates 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 image artifacts (ASTM F2119-07). The non-clinical performance data demonstrate that the subject devices, when exposed to the MR environment under specific MR conditions of use, raise no new questions of safety or efficacy. {34}------------------------------------------------ Image /page/34/Picture/1 description: The image shows the logo for DePuy Synthes, a company that is part of the Johnson & Johnson family of companies. The logo consists of a circular symbol on the left, followed by the company name in blue text. To the right of the company name is the phrase "People inspired" in a light brown script font. Below the company name is the phrase "PART OF THE Johnson-Johnson FAMILY OF COMPANIES" in smaller, gray text. Date Prepared: October 29, 2018 ### 1.1 Submitter ### Primary Contact: Jeffrey Krawiec Regulatory Affairs Specialist DePuy Synthes 1301 Goshen Parkway West Chester, PA 19380 Phone: (610) 719-5434 Jkrawiec@its.jnj.com ### Alternate Contact: Thomas Shea Manager, Regulatory Affairs DePuy Synthes 1301 Goshen Parkway West Chester, PA 19380 Phone: (610) 719-5679 tshea@its.jnj.com ### 1.2. Device Name of Device: DePuy Synthes Anatomical Locking Plate System – MR Conditional Classification Name(s): Screw, Fixation, Bone Regulatory Class: Class II, §888.3040 Product Code(s): HWC, HRS 1.3. Predicate Device K961413 Synthes Anatomical Locking Plate System ## 1.4. Device Description The Anatomical Locking Plate System utilizes a locking feature that secures the screw to the plate, enabling stable fixation to be achieved via unicortical fixation. The plates are available with and without an anatomically contoured head, in a variety of sizes. The head of the screw has a round cross section with a conical underside to fit into the plate. The underside has a tapered thread to match the design of the holes in the plate. The screws are available in thread diameters from 3 mm to 5 mm, in a variety of lengths. ## 1.5. Intended Use The DePuy Synthes Anatomical Locking Plate System indicated to treat fractures (including but not limited to) the radius, ulna, humerus, tibia, fibula, femur. {35}------------------------------------------------ Image /page/35/Picture/1 description: The image features the DePuy Synthes logo, which includes a golden emblem resembling interconnected circles. Next to it, the company name "DePuy Synthes" is written in a bold, dark blue font. Underneath the company name, there is a smaller text indicating that it is "PART OF THE Johnson & Johnson FAMILY OF COMPANIES", and to the right of the company name, the phrase "People inspired" is written in an elegant, cursive font. # 1.6. Substantial Equivalence The purpose of this submission is to add MR Conditional information to the device labeling for the DePuy Synthes Anatomical Locking Plate System. The intended use and technological characteristics of the devices remains unchanged. Non-clinical testing is provided to support the conditional safety of the DePuy Synthes Anatomical Locking Plate System 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 image artifacts (ASTM F2119-07). The non-clinical performance data demonstrate that the subject devices, when exposed to the MR environment under specific MR conditions of use, raise no new questions of safety or efficacy. {36}------------------------------------------------ Image /page/36/Picture/1 description: The image shows the logo for DePuy Synthes, a company that is part of the Johnson & Johnson family of companies. The logo consists of a circular graphic on the left, followed by the company name in blue text. To the right of the company name is the phrase "People inspired" in a light brown script font. Below the company name is the text "PART OF THE Johnson-Johnson FAMILY OF COMPANIES" in a smaller font size. Date Prepared: October 29, 2018 ### 1.1 Submitter ### Primary Contact: Jeffrey Krawiec Regulatory Affairs Specialist DePuy Synthes 1301 Goshen Parkway West Chester, PA 19380 Phone: (610) 719-5434 Jkrawiec@its.jnj.com ### Alternate Contact: Thomas Shea Manager, Regulatory Affairs DePuy Synthes 1301 Goshen Parkway West Chester, PA 19380 Phone: (610) 719-5679 tshea@its.jnj.com ### 1.2. Device Name of Device: DePuy Synthes Cannulated Angle Blade Plate (CABP) System – MR Conditional Classification Name(s): Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Regulatory Class: Class II, §888.3030 Product Code(s): KTT ### 1.3. Predicate Device K974537 Synthes Cannulated Angle Blade Plate (CABP) System ## 1.4. Device Description The CABP is a straight plate with a blade at the head to allow for better fixation in the head of the humerus or in the distal tibia. The blade of the plate is cannulated to fit over a guide wire, allowing for the adjustment of the wire placement several times without adversely affecting the final result. There are cuts in the undersurface of the plate the surface area of the plate in contact with bone. The area of contact between the plate and the bone is decreased in an effort to reduce damage to the cortical blood supply under the plat, and resultant reduction in damage-induced porosis and remodeling of the bone near the plate undersurface. Plate undercuts also make the bending properties of the plate more uniform, which facilitate contouring. The plate has round and dynamic compression screw {37}------------------------------------------------ Image /page/37/Picture/1 description: The image shows the logo for DePuy Synthes, a company that is part of the Johnson & Johnson family of companies. The logo consists of a circular symbol on the left, followed by the company name in blue text. To the right of the company name is the phrase "People inspired" in a cursive font. Below the company name is the text "PART OF THE Johnson-Johnson FAMILY OF COMPANIES" in a smaller font. holes, accepts 4.5mm and 6.5 mm screws, is available in multiple blade lengths, and is manufactured from stainless steel and commercially pure titanium. ## 1.5. Intended Use The DePuy Synthes CABP System is a plate and screw system intended to treat fractures of the proximal humerus and distal tibia. Proximal humerus fractures include two-part greater tubercle fractures and fracture dislocations, two-part surgical neck fractures and fracture dislocations, three-part fractures or fracture dislocations, fractures in osteopenic bone, and nonunions and malunions. Distal tibia fractures include acute fractures in osteopenic bone, and nonunions and malunions. # 1.6. Substantial Equivalence The purpose of this submission is to add MR Conditional information to the device labeling for the DePuy Synthes Cannulated Angle Blade Plate (CABP) System. The intended use and technological characteristics of the devices remains unchanged. Non-clinical testing is provided to support the conditional safety of the DePuy Synthes Cannulated Angle Blade Plate (CABP) System 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 image artifacts (ASTM F2119-07). The non-clinical performance data demonstrate that the subject devices, when exposed to the MR environment under specific MR conditions of use, raise no new questions of safety or efficacy. {38}------------------------------------------------ Image /page/38/Picture/1 description: The image shows the logo for DePuy Synthes, a company that is part of the Johnson & Johnson family of companies. The logo consists of a circular symbol on the left, followed by the company name in blue text. To the right of the company name is the phrase "People inspired" in a light brown script font. Below the company name is the phrase "PART OF THE Johnson-Johnson FAMILY OF COMPANIES" in smaller, gray text. Date Prepared: October 29, 2018 ### 1.1 Submitter ### Primary Contact: Jeffrey Krawiec Regulatory Affairs Specialist DePuy Synthes 1301 Goshen Parkway West Chester, PA 19380 Phone: (610) 719-5434 Jkrawiec@its.jnj.com ### Alternate Contact: Thomas Shea Manager, Regulatory Affairs DePuy Synthes 1301 Goshen Parkway West Chester, PA 19380 Phone: (610) 719-5679 tshea@its.jnj.com ### 1.2. Device Name of Device: DePuy Synthes 3.5 mm 90° Cannulated Limited Contact-Angled Blade Plates – MR Conditional Classification Name(s): Appliance, Fixation, Nail/Blade/Plate Combination, Single Component Regulatory Class: Class II, §888.3030 Product Code(s): KTW ### 1.3. Predicate Device K992837 Synthes 3.5 mm 90° Cannulated Limited Contact-Angled Blade Plates ### 1.4. Device Description The DePuy Synthes 3.5 mm 90° Cannulated LC-ABP provides stable fracture fixation and rotational control for fractures of the proximal humerus and distal tibia. The plates feature a low profile limited contact dynamic compression plate (LC-DCP®) design and dynamic compression unit (DCU) screw holes. The blade portion of the plate is cannulated to accept a 2.0 mm guide wire. The plates are available in various sizes to accommodate varying patient anatomy. {39}------------------------------------------------ Image /page/39/Picture/1 description: The image displays the logo for DePuy Synthes, a company that is part of the Johnson & Johnson family of companies. The logo features a geometric 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 a cursive, light brown font. # 1.5. Intended Use The DePuy Synthes 3.5 mm 90° Cannulated Limited Contact Angled Blade Plates are intended for the fixation of fractures and non-unions of the proximal humerus and distal tibia. # 1.6. Substantial Equivalence The purpose of this submission is to add MR Conditional information to the device labeling for the DePuy Synthes 3.5 mm 90° Cannulated Limited Contact-Angled Blade Plates. The intended use and technological characteristics of the devices remains unchanged. Non-clinical testing is provided to support the conditional safety of the DePuy Synthes 3.5 mm 90° Cannulated Limited Contact-Angled Blade Plates 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 image artifacts (ASTM F2119-07). The non-clinical performance data demonstrate that the subject devices, when exposed to the MR environment under specific MR conditions of use, raise no new questions of safety or efficacy. {40}------------------------------------------------ Image /page/40/Picture/1 description: The image displays the logo for DePuy Synthes, a company that is part of the Johnson & Johnson family of companies. The logo features a geometric symbol resembling interconnected circles in a light brown color, followed by the company name "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, light brown font, adding a personal touch to the brand's image. Date Prepared: October 29, 2018 ### 1.1 Submitter ### Primary Contact: Jeffrey Krawiec Regulatory Affairs Specialist DePuy Synthes 1301 Goshen Parkway West Chester, PA 19380 Phone: (610) 719-5434 Jkrawiec@its.jnj.com ### Alternate Contact: Thomas Shea Manager, Regulatory Affairs DePuy Synthes 1301 Goshen Parkway West Chester, PA 19380 Phone: (610) 719-5679 tshea@its.jnj.com ## 1.2. Device Name of Device: DePuy Synthes Large Fragment Dynamic Compression Locking (DCL) System - MR Conditional Classification Name(s): Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Regulatory Class: Class II, §888.3030 Product Code(s): KTT ### 1.3. Predicate Device K000682 Synthes Large Fragment Dynamic Compression Locking (DCL) System ## 1.4. Device Description The Large Fragment DCL system consists of limited-contact profile plates in broad and narrow sizes, which include combination dynamic compression/locking screw holes. The plates accept 4.5 mm cortex, 6.5 mm cancellous, 4.5 mm cannulated, 7.0 mm cannulated, and 5.0 mm locking screws. This device is manufactured in either stainless steel or titanium. {41}------------------------------------------------ Image /page/41/Picture/1 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 overlapping shapes, followed by the text "DePuy Synthes" in blue. To the right of the company name, the words "People inspired" are written in a cursive font. # 1.5. Intended Use The DePuy Synthes Large Fragment DCL is intended for fixation of various long bones, such as the humerus, femur and tibia. Also for use in fixation of osteopenic bone and fixation of non-unions or malunions. # 1.6. Substantial Equivalence The purpose of this submission is to add MR Conditional information to the device labeling for the DePuy Synthes Large Fragment Dynamic Compression Locking (DCL) System. The intended use and technological characteristics of the devices remains unchanged. Non-clinical testing is provided to support the conditional safety of the DePuy Synthes Large Fragment Dynamic Compression Locking (DCL) System 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 image artifacts (ASTM F2119-07). The non-clinical performance data demonstrate that the subject devices, when exposed to the MR environment under specific MR conditions of use, raise no new questions of safety or efficacy. {42}------------------------------------------------ Image /page/42/Picture/1 description: The image displays the logo for DePuy Synthes, a company that is part of the Johnson & Johnson family of companies. The logo features a circular graphic element on the left, followed by the company name in a bold, blue font. To the right of the company name, the phrase "People inspired" is written in a cursive, light-colored font. Below the company name, the text "PART OF THE Johnson-Johnson FAMILY OF COMPANIES" is present in a smaller font size. Date Prepared: October 29, 2018 ### 1.1 Submitter ### Primary Contact: Jeffrey Krawiec Regulatory Affairs Specialist DePuy Synthes 1301 Goshen Parkway West Chester, PA 19380 Phone: (610) 719-5434 Jkrawiec@its.jnj.com ### Alternate Contact: Thomas Shea Manager, Regulatory Affairs DePuy Synthes 1301 Goshen Parkway West Chester, PA 19380 Phone: (610) 719-5679 tshea@its.jnj.com ### 1.2. Device Name of Device: DePuy Synthes Large Fragment Locking Compression Plate (LCP) System -T Plate - MR Conditional Classification Name(s): Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Regulatory Class: Class II, §888.3030 Product Code(s): KTT ### 1.3. Predicate Device K010766 Synthes (USA) Large Fragment Locking Compression Plate (LCP) System - T Plate ### 1.4. Device Description The DePuy Synthes Locking Compression Plate (LCP) System - T Plate is a buttress plate and screw system. The primary feature of the plate is round holes combined with locking screw holes. The locking screws form a locked, fixed angle construct with the plate, while the standard screws facilitate reduction and create compression between the plate and bone. The plates accept 4.5 mm cortex, 6.5 mm cancellous, 4.5 mm cannulated, 7.0 mm cannulated, 7.3 mm cannulated, 4.0 mm and 5.0 mm locking screws {43}------------------------------------------------ Image /page/43/Picture/1 description: The image shows the logo for DePuy Synthes, a company that is part of the Johnson & Johnson family of companies. The logo consists of a gold-colored symbol that looks like three overlapping circles, followed by the company name in blue, and the tagline "People inspired" in a light brown script font. Below the company name, in smaller font, it says "PART OF THE Johnson & Johnson FAMILY OF COMPANIES". # 1.5. Intended Use The DePuy Synthes Large Fragment Locking Compression Plate (LCP) System - T Plate is intended to buttress metaphyseal fractures of the proximal humerus, medial tibial plateau and distal tibia. Also for use in fixation of osteopenic bone and fixation of non-unions and malunions. # 1.6. Substantial Equivalence The purpose of this submission is to add MR Conditional information to the device labeling for the DePuy Synthes (USA) Large Fragment Locking Compression Plate (LCP) System - T Plate. The intended use and technological characteristics of the devices remains unchanged. Non-clinical testing is provided to support the conditional safety of the DePuy Synthes (USA) Large Fragment Locking Compression Plate (LCP) System - T Plate 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 image artifacts (ASTM F2119-07). The non-clinical performance data demonstrate that the subject devices, when exposed to the MR environment under specific MR conditions of use, raise no new questions of safety or efficacy. {44}------------------------------------------------ Image /page/44/Picture/1 description: The image shows the logo for DePuy Synthes, a company that is part of the Johnson & Johnson family of companies. The logo consists of a symbol that looks like two overlapping circles, followed by the company name in blue text. To the right of the company name, the words "People inspired" are written in a cursive font. Date Prepared: October 29, 2018 ### 1.1 Submitter ### Primary Contact: Jeffrey Krawiec Regulatory Affairs Specialist DePuy Synthes 1301 Goshen Parkway West Chester, PA 19380 Phone: (610) 719-5434 Jkrawiec@its.jnj.com ### Alternate Contact: Thomas Shea Manager, Regulatory Affairs DePuy Synthes 1301 Goshen Parkway West Chester, PA 19380 Phone: (610) 719-5679 tshea@its.jnj.com ### 1.2. Device Name of Device: DePuy Synthes Curved Reconstruction Plate – MR Conditional Classification Name(s): Plate, Fixation, Bone Regulatory Class: Class II, §888.3030 Product Code(s): HRS 1.3. Predicate Device K011334 Synthes Curved Reconstruction Plate ## 1.4. Device Description The DePuy Synthes Curved Reconstruction Plate line extension is a pre-curved version of the currently marketed Straight Locking Reconstruction Plate. Both of these plates will be included as part of the DePuy Synthes Small Fragment DCL System. Both the curved and straight plates have the same intended use and there is no change in safety or efficacy. ## 1.5. Intended Use The DePuy Synthes Curved Reconstruction Plate is intended for fixation of fractures, osteotomies, and non-unions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, distal tibia, and fibula, particularly in osteopenic bone as a part of the DePuy Synthes Small Fragment DCL System. {45}------------------------------------------------ Image /page/45/Picture/1 description: The image shows the logo for DePuy Synthes, a company that is part of the Johnson & Johnson family of companies. The logo consists of a circular symbol to the left of the company name, which is written in blue. To the right of the company name, the phrase "People inspired" is written in a cursive font. # 1.6. Substantial Equivalence The purpose of this submission is to add MR Conditional information to the device labeling for the DePuy Synthes Curved Reconstruction Plate. The intended use and technological characteristics of the devices remains unchanged. Non-clinical testing is provided to support the conditional safety of the DePuy Synthes Curved Reconstruction Plate 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 image artifacts (ASTM F2119-07). The non-clinical performance data demonstrate that the subject devices, when exposed to the MR environment under specific MR conditions of use, raise no new questions of safety or efficacy. {46}------------------------------------------------ Image /page/46/Picture/1 description: The image displays the logo for DePuy Synthes, a company that is part of the Johnson & Johnson family of companies. The logo features a circular graphic element on the left, followed by the company name in a bold, blue font. To the right of the company name, the phrase "People inspired" is written in a cursive, light-colored font. Below the company name, the text "PART OF THE Johnson-Johnson FAMILY OF COMPANIES" is present in a smaller font size. Date Prepared: October 29, 2018 #…
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