DePuy Synthes Trauma Orthopedic Nail Implants

K182783 · DePuy Synthes · HRS · Dec 26, 2018 · Orthopedic

Device Facts

Record IDK182783
Device NameDePuy Synthes Trauma Orthopedic Nail Implants
ApplicantDePuy Synthes
Product CodeHRS · Orthopedic
Decision DateDec 26, 2018
DecisionSESE
Submission TypeTraditional
Regulation21 CFR 888.3030
Device ClassClass 2
AttributesTherapeutic

Intended Use

The DePuy Synthes Trochanter Stabilization Plate (TSP) for DHS is intended to treat stable intertrochanteric, subtrochanteric, pertrochanteric and basilar neck fractures when used in conjunction with the DePuy Synthes Dynamic Hip Screw (DHS) plating system.

Device Story

The DePuy Synthes Trochanter Stabilization Plate (TSP) is a metallic bone fixation component designed to fit over the sideplate of the Dynamic Hip Screw (DHS) system. It features a spoon-shaped proximal area that resides along the greater trochanter and a shaft with screw holes for fixation to the femoral shaft. The device is used by orthopedic surgeons in a clinical setting to provide additional stability for proximal femoral fractures. By securing the plate to the DHS system and the femoral shaft, it helps maintain fracture reduction and alignment, potentially facilitating bone healing and patient recovery. The device is provided either pre-sterilized by gamma radiation or non-sterile for hospital-based sterilization.

Clinical Evidence

Bench testing only. Non-clinical performance data provided to support MR Conditional safety, including assessment of magnetically induced displacement force, torque, RF heating, and image artifacts.

Technological Characteristics

Metallic bone fixation plate; component of DHS system. Materials include metal (specific alloy not detailed in summary). Sterilization via gamma radiation or user-facility methods. MR Conditional status supported by ASTM F2052-14, F2213-06, F2182-11a, and F2119-07.

Indications for Use

Indicated for stable and unstable intertrochanteric, subtrochanteric, pertrochanteric, and basilar neck fractures when used with the DHS plating system.

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}------------------------------------------------ December 26, 2018 Image /page/0/Picture/1 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. DePuy Synthes Elizabeth Jacobs Regulatory Affairs Project Leader 1301 Goshen Parkway West Chester, Pennsylvania 19380 ## Re: K182783 Trade/Device Name: see page 3, List of Cleared Devices in K182783 Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances And Accessories Regulatory Class: Class II Product Code: HRS. HSB. HTY. JDS. JDW. KTT. LXT Dated: September 28, 2018 Received: October 1, 2018 ## Dear Elizabeth Jacobs: 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 {1}------------------------------------------------ 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.htm); 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, Shumaya Ali -S for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure: List of Cleared Devices in K182783 {2}------------------------------------------------ # List of Cleared Devices in K182783 - 1. DePuy Synthes Trochanter Stabilization Plate for DHS MR Conditional - 2. Modification to DePuy Synthes Trochanter Stabilization Plate (TSP) for DHS (Line Extension) MR Conditional - 3. DePuy Synthes Proximal Humeral Nail MR Conditional - 4. DePuy Synthes Trochanteric Fixation Nail (TFN) System MR Conditional - 5. DePuy Synthes Retrograde/Antegrade Femoral Nail System MR Conditional - 6. DePuy Synthes Lateral Entry Femoral Nail System MR Conditional - 7. DePuy Synthes Elastic Intramedullary Nail (EIN) System (Line Extension) MR Conditional - 8. DePuy Synthes LCP Dynamic Helical Hip System MR Conditional - 9. DePuy Synthes Hindfoot Arthrodesis Nail System MR Conditional - 10. DePuy Synthes Universal Locking Trochanter Stabilization Plate MR Conditional - 11. DePuy Synthes Trochanteric Fixation Nail (TFN) System MR Conditional - 12. DePuy Synthes Adolescent Lateral Entry Femoral Nail System MR Conditional - 13. DePuy Synthes Olecranon Osteotomy Nailing (OleON) System MR Conditional - 14. DePuy Synthes Trochanteric Fixation Nail (TFN) Screw MR Conditional - 15. DePuy Synthes Set Screw for Ti Trochanteric Fixation Nail (TFN) MR Conditional - 16. DePuy Synthes Trochanteric Fixation Nail Advanced (TFNA) System MR Conditional - 17. DePuy Synthes Universal Femoral Nail MR Conditional - 18. DePuy Synthes Universal Tibial Nail and the DePuy Synthes Unreamed Tibial Nail MR Conditional - 19. DePuy Synthes TI-6AL-7NB Unreamed Femoral Nail MR Conditional - 20. DePuy Synthes TI-6AL-7NB Unreamed Tibial Nail (URTN) MR Conditional - 21. Accessories to DePuy Synthes Titanium Alloy Unreamed Femoral Nail (URFN) MR Conditional - 22. DePuy Synthes Unreamed Humeral Nail (URHN) MR Conditional - 23. DePuy Synthes Cannulated Femoral Nail (CFN) MR Conditional - 24. DePuy Synthes Titanium Cannulated Tibial Nail (TICTN) MR Conditional - 25. DePuy Synthes Proximal Femoral Nail (PFN) System MR Conditional - 26. DePuy Synthes Titanium Distal Femoral Nail (TI DFN) System MR Conditional - 27. DePuy Synthes Elastic Intramedullary Nail (EIN) System MR Conditional - 28. DePuy Synthes Spiral Blade for Humeral Nail (SBHN) MR Conditional {3}------------------------------------------------ # Indications for Use Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below. 510(k) Number (if known) K182783 Device Name DePuy Synthes Trochanter Stabilization Plate for DHS - MR Conditional Indications for Use (Describe) The DePuy Synthes Trochanter Stabilization Plate (TSP) for DHS is intended to treat stable intertrochanteric, subtrochanteric, pertrochanteric and basilar neck fractures when used in conjunction with the DePuy Synthes Dynamic Hip Screw (DHS) plating system. | 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}------------------------------------------------ # Indications for Use Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below. 510(k) Number (if known) K182783 Device Name Modification to DePuy Synthes Trochanter Stabilization Plate (Line Extension) - MR Conditional Indications for Use (Describe) The DePuy Synthes Trochanter Stabilization Plate (TSP) for the Dynamic Hip Screw System (DHS®) is intended to treat stable and unstable intertrochanteric, pertrochanteric and basilar neck fractures when used in conjunction with the DHS® System. | Type of Use (Select one or both, as applicable) | | |-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | <div> <span> <svg height="16" width="16"> <rect fill="white" height="16" stroke="black" stroke-width="1" width="16"></rect> <line stroke="black" stroke-width="2" x1="2" x2="14" y1="2" y2="14"></line> <line stroke="black" stroke-width="2" x1="14" x2="2" y1="2" y2="14"></line> </svg> </span> Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> <span> <svg height="16" width="16"> <rect fill="white" height="16" stroke="black" stroke-width="1" width="16"></rect> </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 {5}------------------------------------------------ # Indications for Use Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below. 510(k) Number (if known) K182783 Device Name DePuy Synthes Proximal Humeral Nail - MR Conditional Indications for Use (Describe) The DePuy Synthes Proximal Humeral Nail is intended for use in fractures of the proximal 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 {6}------------------------------------------------ Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below. ## DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration # Indications for Use 510(k) Number (if known) K182783 Device Name DePuy Synthes Trochanteric Fixation Nail (TFN) System - MR Conditional Indications for Use (Describe) The DePuy Synthes Trochanteric Fixation Nail (TFN) System is intended to treat stable fractures of the proximal femur including pertrochanteric fractures, intertrochanteric fractures, and combinations thereof. The Long TFN is additionally indicated for subtrochanteric fractures, pertrochanteric fractures associated with shaft fractures, pathologic fractures (including prophylactic use) in both trochanteric and diaphyseal regions, long subtrochanteric fractures, proximal or distal non-unions, malunions, and revisions. Type of Use (Select one or both, as applicable) | <span style="font-family: Arial;"> <span style="font-size: 10pt;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D)</span> | |-----------------------------------------------------------------------------------------------------------------------------------| | <span style="font-family: Arial;"> <span style="font-size: 10pt;">☐</span> 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 {7}------------------------------------------------ ## Indications for Use ### 510(k) Number (if known) ### K182783 Device Name DePuy Synthes Retrograde/Antegrade Femoral Nail System - MR Conditional Indications for Use (Describe) The DePuy Synthes Retrograde/Antegrade Femoral Nail System is intended to stabilize fractures of the distal femur and the femoral shaft, including: - · supracondylar fractures, including those with intra-articular extension; - · ipsilateral hip/shaft fractures; - · ipsilateral femur/tibia fractures; - · femoral fractures in multiple trauma patients; - · fractures proximal to total knee arthroplasty; - · fractures distal to a hip implant; - · fractures in the morbidly obese; - · fractures in osteoporotic bone, impending pathologic fractures; - · malunions and nonunions | 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}------------------------------------------------ # Indications for Use Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below. 510(k) Number (if known) K182783 Device Name DePuy Synthes Lateral Entry Femoral Nail System - MR Conditional Indications for Use (Describe) The DePuy Synthes Lateral Entry Femoral Nail System is intended to stabilize femoral shaft fractures, subtrochanteric fractures, ipsilateral neck/shaft fractures, impending pathologic fractures, non-unions and malunions. | Type of Use (Select one or both, as applicable) | | |-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--| | <div style="display:flex; align-items:center;"> <div style="margin-right:5px;"> <span style="font-size: 20px;">☑</span> </div> <div>Prescription Use (Part 21 CFR 201 Subpart D)</div> </div> | | | <div style="display:flex; align-items:center;"> <div style="margin-right:5px;"> <span style="font-size: 20px;">☐</span> </div> <div>Over-The-Counter Use (21 CFR 201 Subpart C)</div> </div> | | > 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 {9}------------------------------------------------ # Indications for Use Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below. 510(k) Number (if known) K182783 ### Device Name DePuy Synthes Elastic Intramedullary Nail (EIN) System (Line Extension) - MR Conditional Indications for Use (Describe) The DePuy Synthes Elastic Intramedullary Nail (EIN) System (Line Extension) is indicated for fixation of diaphyseal fractures where the canal is narrow or flexibility of the implant is paramount. This includes upper extremity fractures in all patients and lower extremity fractures in pediatric or small-stature patients. This system is also intended to treat metaphyseal and epiphyseal fractures, such as radial neck fractures and is intended for fixation of small long bones, such as carpal and tarsal bones. In pediatic applications, the flexibility of the EIN allows it to be inserted at a point which avoids disruption to the bone growth plate. | Type of Use (Select one or both, as applicable) | | |-------------------------------------------------------------------------------|------------------------------------------------------------------------------| | <div> <span> </span> Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> <span> </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 {10}------------------------------------------------ # Indications for Use Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below. 510(k) Number (if known) K182783 Device Name DePuy Synthes LCP Dynamic Helical Hip System - MR Conditional Indications for Use (Describe) The DePuy Synthes LCP Dynamic Helical Hip System, Additional Helix Blades is intended to treat stable and unstable intertrochanteric, subtrochanteric and basilar neck fractures in which a stable medial buttress can be reconstructed. Type of Use (Select one or both, as applicable) | <span style="text-decoration: underline;">☒</span> Research Use (R+d, 21 CFR 201.3 Subpart D) | ☐ Therapy, Study, Use (21 CFR 201.3 Subpart D) | |-----------------------------------------------------------------------------------------------|------------------------------------------------| |-----------------------------------------------------------------------------------------------|------------------------------------------------| > 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}------------------------------------------------ # Indications for Use Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below. 510(k) Number (if known) K182783 Device Name DePuy Synthes Hindfoot Arthrodesis Nail System - MR Conditional Indications for Use (Describe) The DePuy Synthes Hindfoot Arthrodesis Nail System is intended to facilitate tibiotalocalcaneal arthrodesis to treat severe foot/ankle deformity, arthritis, instability, and skeletal defects after turnor resection. These include, but are not limited to Neuro-osteoarthropathy (Charcot's Foot), Avascular Necrosis of the talus, failed joint replacement, failed ankle fusion, distal tibia fracture non-unions, Osteoarthritis, Rheumatoid Arthritis, and Pseudoarthrosis. | Type of Use (Select one or both, as applicable) | | |----------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------| | <span style="font-family: sans-serif;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="font-family: 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 {12}------------------------------------------------ Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below. ## DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration # Indications for Use 510(k) Number (if known) K182783 Device Name DePuy Synthes Universal Locking Trochanter Stabilization Plate - MR Conditional Indications for Use (Describe) The DePuy Synthes Universal Locking Trochanter Stabilization Plate (ULTSP) for DHS or LCP DHHS is intented to treat stable and unstable intertrochanteric, pertrochanteric and basilar neck fractures when used in conjunction with the Synthes Dynamic Hip Screw (DHS) or the LCP Dynamic Helical Hip System (DHHS) side plates with four or more holes. | Type of Use (Select one or both, as applicable) | | |---------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------| | <div> <span>☑</span> <span>Prescription Use (Part 21 CFR 801 Subpart D)</span> </div> | <div> <span>☐</span> <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. ## DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration # Indications for Use 510(k) Number (if known) K182783 Device Name DePuy Synthes Trochanteric Fixation Nail (TFN) System - MR Conditional Indications for Use (Describe) The DePuy Synthes Trochanteric Fixation Nail (TFN) System, Additional Helical Blades is intended to treat stable and unstable fractures of the proximal femur including pertrochanteric fractures, intertrochanteric fractures, basal neck fractures, and combinations thereof. The Long TFN is additionally indicated for subtrochanteric fractures associated with shaft fractures, pathologic fractures (including prophylactic use) in both trochanteric and diaphyseal regions, long subtrochanteric fractures, proximal or distal non-unions, and revisions. | Type of Use (Select one or both, as applicable) | |-------------------------------------------------| |-------------------------------------------------| | <span style="display:inline-block;"> <input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) </span> | <span style="display:inline-block;"> <input type="checkbox"/> 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 {14}------------------------------------------------ # Indications for Use Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below. 510(k) Number (if known) K182783 Device Name DePuy Synthes Adolescent Lateral Entry Femoral Nail System - MR Conditional Indications for Use (Describe) The DePuy Synthes Adolescent Lateral Entry Femoral Nail System will be intended to stabilize fractures of the femoral shaft, subtrochanteric fractures, ipsilateral neck/shaft fractures, impending pathologic fractures, non-unions in adolescent and small stature adult 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 {15}------------------------------------------------ # Indications for Use Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below. 510(k) Number (if known) K182783 Device Name DePuy Synthes Olecranon Osteotomy Nailing (OleON) System - MR Conditional Indications for Use (Describe) The DePuy Synthes Olecranon Osteotomy Nailing (OleON) System is intended to treat olecranion osteotomies as well as simple fractures of the olecranon. | 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. ## DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration # Indications for Use 510(k) Number (if known) K182783 Device Name DePuy Synthes Trochanteric Fixation Nail (TFN) Screw - MR Conditional Indications for Use (Describe) As part of the DePuy Synthes Trochanteric Fixation Nail (TFN) System, the DePuy Synthes Trochanteric Fixation Nail (TFN) Screw is intended to treat stable and unstable fractures of the proximal femur including pertrochanteric fractures, intertrochanteric fractures, basal neck fractures, and combinations thereof. The Long TFN is additionally indicated for subtrochanteric fractures, pertrochanteric fractures associated with shaft fractures (including prophylactic use) in both trochanteric and diaphyseal regions, long subtrochanteric fractures, proximal or distal nonunions, malunions, and revisions. | Type of Use (Select one or both, as applicable) | | |-------------------------------------------------------------------------------------|------------------------------------------------------------------------------------| | <span style="font-size:10pt;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="font-size:10pt;">☐</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 {17}------------------------------------------------ # Indications for Use Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below. 510(k) Number (if known) K182783 Device Name DePuy Synthes Set Screw for Ti Trochanteric Fixation Nail (TFN) - MR Conditional Indications for Use (Describe) The DePuy Synthes Set Screw for Ti Trochanteric Fixation Nail (TFN) is intended to treat stable and unstable fractures of the proximal femur including pertrochanteric fractures, intertrochanteric fractures and combinations thereof. The long TFN is additionally indicated for subtrochanteric fractures, pertrochanteric fractures associated with shaft fractures, pathologic fractures (including prophylactic use) in both trochanteric and diaphyseal regions, long subtrochanteric fractures, proximal or distal non-unions, malunions, and revisions. Type of Use (Select one or both, as applicable): | <span style="font-size:10pt"></span> | <span style="font-size:10pt"></span> | |----------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------| | <span style="font-size:10pt"></span> <span style="font-size:10pt"> <input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</span> | <span style="font-size:10pt"> <input type="checkbox"/> 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 {18}------------------------------------------------ # Indications for Use 510(k) Number (if known) ## K182783 Device Name DePuy Synthes Trochanteric Fixation Nail - Advanced (TFNA) System - MR Conditional Indications for Use (Describe) The DePuy Synthes Trochanteric Fixation Nail - Advanced (TFNA) System is intended for treatment offractures in adults and adolescents (12-21) in which the growth plates have fused. Specifically, the system is indicated for: - · Stable and unstable pertrochanteric fractures - · Intertrochanteric fractures - · Basal neck fractures - · Combinations of pertrochanteric, intertrochanteric and basal neck fractures The Long Nail is additionally intended for treatment of fractures in adults and adolescents (12-21) in which the growth plates have fused for the following indications: - · Subtrochanteric fractures - Pertrochanteric fractures associated with shaft fractures - · Pathologic fractures (including prophylactic use) in both trochanteric and diaphyseal regions - · Long Subtrochanteric fractures - · Proximal or distal non-unions, malunions and revisions Type of Use (Select one or both, as applicable) | <div> <span style="font-size:16px">☒</span> 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 {19}------------------------------------------------ # Indications for Use Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below. 510(k) Number (if known) K182783 Device Name DePuy Synthes Universal Femoral Nail - MR Conditional Indications for Use (Describe) The DePuy Synthes Universal Femoral Nail is intended for use in stabilizing fractures of the femur. More specifically, the primary intended use is stable midshaft (diaphyseal) femoral fracture and hypertrophic pseudarthrosis (non-union) or unstable femoral fracture stabilization. | 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 {20}------------------------------------------------ # Indications for Use Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below. 510(k) Number (if known) K182783 ### Device Name DePuy Synthes Universal Tibial Nail and the DePuy Synthes Unreamed Tibial Nail - MR Conditional Indications for Use (Describe) The DePuy Synthes Universal Tibial Nail and the DePuy Synthes Unreamed Tibial Nail are intended for use in stabilizing fractures of the tibia. More specifically, the primary intended use of the Universal Tibial Nail is stable diaphyseal fractures or long or rotationally-unstable diaphyseal fractures, including rotationally unstable proximal and distal diaphyseal fractures. For the Unreamed Tibial Nail, the specific intended uses are Grade I and II open tibial diaphyseal fractures; high energy, unstable, closed fracture patterns; comminuted fractures of tibias with small medullary canals; and certain pre- and postisthmic fractures. | 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 {21}------------------------------------------------ # Indications for Use Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below. 510(k) Number (if known) K182783 Device Name DePuy Synthes TI-6AL-7NB Unreamed Femoral Nail - MR Conditional Indications for Use (Describe) The DePuy Synthes TI-6AI-7NB Unreamed Femoral Nail is intended for use in stabilizing fractures of the femur. Specific Indications: Acute femoral diaphyseal fractures; post-isthmic femoral fractures; subtrochanteric femoral fractures. | Type of Use (Select one or both, as applicable) | |-------------------------------------------------| |-------------------------------------------------| | <span style="font-family: sans-serif;"> <svg height="16" width="16"> <rect fill="white" height="16" stroke="black" stroke-width="1" width="16"></rect> <path d="M2,2 L14,14 M14,2 L2,14" stroke="black" stroke-width="2"></path> </svg> </span> Prescription Use (Part 21 CFR 801 Subpart D) | |----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | <span style="font-family: sans-serif;"> <svg height="16" width="16"> <rect fill="white" height="16" stroke="black" stroke-width="1" width="16"></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 {22}------------------------------------------------ # Indications for Use Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below. 510(k) Number (if known) K182783 Device Name DePuy Synthes TI-6AL-7NB Unreamed Tibial Nail (URTN) - MR Conditional Indications for Use (Describe) The DePuy Synthes TI-6AL-7NB Unreamed Tibial Nail (URTN) is intended to stabilize fractures of the tibia. Specifically, it is intended for grade I and II open tibial diaphyseal fractures; high energy, unstable, closed fracture patterns; comminuted fractures of tibiae with small medullary canals; and certain pre- and post-isthmic fractures. Type of Use (Select one or both, as applicable) | <span style="font-family: sans-serif;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) | |----------------------------------------------------------------------------------------------| | <span style="font-family: 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 {23}------------------------------------------------ Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below. ## DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration # Indications for Use 510(k) Number (if known) K182783 Device Name Accessories to DePuy Synthes Titanium Alloy Unreamed Femoral Nail (URFN) - MR Conditional Indications for Use (Describe) The accessories are intended for use with the DePuy Synthes Titanium Alloy Unreamed Femoral Nail (URFN), which is intended for use in stabilizing fractures of the femur. The Synthes Twisted Blade and 5.0 mm Shaft Screw, used with the Locking Sleeve and End Cap, are intended to transmit load between the URFN to prevent rotation and displacement of the nail/fracture when stabilizing subtrochanteric femoral fractures (short, long, reverse oblique and comminuted). | 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 {24}------------------------------------------------ # Indications for Use Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below. 510(k) Number (if known) K182783 Device Name DePuy Synthes Unreamed Humeral Nail (URHN) - MR Conditional Indications for Use (Describe) The DePuy Synthes Unreamed Humeral Nail (URHN) is intended to stabilize fractures of the humerus. It is specifically indicated for acute humeral shaft fractures, pathologic fractures of the humeral shaft, and nonand mal unions of the humeral shaft. | Type of Use (Select one or both, as applicable) | | |--------------------------------------------------------------------------------------|-----------------------------------------------| | <span style="font-size: 10pt;">☑</span> 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 {25}------------------------------------------------ Form Approved: OMB No. 0910-0120 ## DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration # Indications for Use Expiration Date: 06/30/2020 See PRA Statement below. 510(k) Number (if known) K182783 Device Name DePuy Synthes Cannulated Femoral Nail (CFN) - MR Conditional Indications for Use (Describe) The DePuy Synthes Cannulated Femoral Nail (CFN) is intended to stabilize fractures of the femur. Specifically, the primary intended use is acute femoral diaphyseal fractures, post-isthmic femoral fractures, subtrochanteric femoral fractures, non-unions and impending pathological fractures. Type of Use (Select one or both, as applicable) | <span style="font-family: Arial;"> <span style="font-size: 10pt;"> <span style="font-style: normal;"> <span style="font-variant: normal;"> <span style="font-weight: normal;"> <span style="letter-spacing: normal;"> <span style="line-height: normal;"> <span style="orphans: 2;"> <span style="text-align: left;"> <span style="text-indent: 0px;"> <span style="text-transform: none;"> <span style="white-space: normal;"> <span style="widows: 2;"> <span style="word-spacing: 0px;"> <span style="display: inline !important;"> <span style="float: none;">☑</span> </span> </span> </span> </span> </span> </span> </span> </span> </span> </span> </span> </span> </span> </span> </span> | Prescription Use (Part 21 CFR 801 Subpart D) | |----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------| | <span style="font-family: Arial;"> <span style="font-size: 10pt;"> <span style="font-style: normal;"> <span style="font-variant: normal;"> <span style="font-weight: normal;"> <span style="letter-spacing: normal;"> <span style="line-height: normal;"> <span style="orphans: 2;"> <span style="text-align: left;"> <span style="text-indent: 0px;"> <span style="text-transform: none;"> <span style="white-space: normal;"> <span style="widows: 2;"> <span style="word-spacing: 0px;"> <span style="display: inline !important;"> <span style="float: none;">☐</span> </span> </span> </span> </span> </span> </span> </span> </span> </span> </span> </span> </span> </span> </span></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 {26}------------------------------------------------ # Indications for Use Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below. 510(k) Number (if known) K182783 Device Name DePuy Synthes Titanium Cannulated Tibial Nail (TI CTN) - MR Conditional Indications for Use (Describe) The DePuy Synthes Titanium Cannulated Tibial Nail (TI CTN) is intended to stabilize fractures of the tibia. Indications include, but are not limited to, open and closed tibial shaft fractures, certain pre- and post-isthmic fractures, tibial malunions and tibial non-unions. | 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 {27}------------------------------------------------ # Indications for Use Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below. 510(k) Number (if known) K182783 Device Name DePuy Synthes Proximal Femoral Nail (PFN) System - MR Conditional Indications for Use (Describe) The DePuy Synthes Proximal Femoral Nail (PFN) System is intended to treat stable and unstable proximal femoral fractures including pertrochanteric fractures, intertrochanteric fractures, high subtrochanteric fractures, and combinations of these fractures. | 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. ## DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration # Indications for Use 510(k) Number (if known) K182783 Device Name DePuy Synthes Titanium Distal Femoral Nail (TI DFN) System - MR Conditional Indications for Use (Describe) The DePuy Synthes Titanium Diastal Femoral Nail (TI DFN) System is generally intended to stabilize fractures of the distal femur. Specifically, the Ti DFN is intended for supracondylar fractures (including those with intra-articular and/or extra-articular involvement), pathologic fractures, mal-unions, ipsilateral hip/shaft fractures, ipsilateral femur/ tibia fractures proximal to a total knee, fractures distal to a total hip, fractures in the multiply injured patient. fractures in the morbidly obese patient, and fractures in osteoporotic bane. The Ti DFN can be used in either reamed or non-reamed applications. | 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:overline;"> </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 {29}------------------------------------------------ # Indications for Use Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below. 510(k) Number (if known) K182783 Device Name DePuy Synthes Elastic Intramedullary Nail (EIN) System - MR Conditional Indications for Use (Describe) The DePuy Synthes Elastic Intramedullary Nail (EIN) System is intended for fixation of the long bones where the medullary canal is narrow or flexibility of the implant is paramount. This includes upper extremity fractures in all patients and lower extremity fractures in pediatric or small-statured patients, the flexibility of the EIN allows it to be inserted at a point which avoids disruption to the bone growth plate. 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 {30}------------------------------------------------ # Indications for Use Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below. 510(k) Number (if known) K182783 Device Name DePuy Synthes Spiral Blade for Humeral Nail (SBHN) - MR Conditional Indications for Use (Describe) The DePuy Synthes Spiral Blade for Humeral Nail (SBHN) is intended to stabilize fractures of the 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 {31}------------------------------------------------ Date Prepared: September 28, 2018 ### Submitter 1.1. ## Primary Contact: Elizabeth Jacobs Regulatory Affairs Project Leader DePuy Synthes 1301 Goshen Parkway West Chester, PA 19380 Phone: (610) 719-5768 Ejacob10@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 Trochanter Stabilization Plate for DHS – MR Conditional Classification Name(s): Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite Regulatory Class: Class II; 888.3030 ## Product Code(s): LXT - 1.3. Predicate Device ## K000972 SYNTHES (USA) TROCHANTER STABILIZATION PLATE FOR DHS ### 1.4. Device Description The DePuy Synthes Trochanter Stabilization Plate for DHS is a component of the DePuy Synthes DHS System, which fits over the sideplate of the DHS. The spoon-shaped area of the TSP, which is proximal to the shaft, resides along the greater trochanter. Screw holes of the TSP shaft line up with the screw holes of the DHS plate to accept the 4.5 mm cortex screws used for fixation to the femoral shaft. Two screw slots accommodate the DHS lag screw and the anti-rotational screw located proximal to it. The DePuy Synthes Trochanter Stabilization Plates are provided both pre-sterilized by gamma radiation and nonsterile. {32}------------------------------------------------ ## 1.5. Indications for Use The DePuy Synthes Trochanter Stabilization Plate (TSP) for DHS is intended to treat stable and unstable intertrochanteric, subtrochanteric and basilar neck fractures when used in conjunction with the DePuy Synthes Dynamic Hip Screw (DHS) plating system. ### Substantial Equivalence 1.6. The purpose of this submission is to add MR Conditional information to the device labeling for the DePuy Synthes Trochanter Stabilization Plate for DHS. 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 Trochanter Stabilization Plate for DHS 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 nonclinical 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. {33}------------------------------------------------ Date Prepared: September 28, 2018 ### 1.1. Submitter Primary Contact: Elizabeth Jacobs Regulatory Affairs Project Leader DePuy Synthes 1301 Goshen Parkway West Chester, PA 19380 Phone: (610) 719-5768 Ejacob10@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: Modification to DePuy Synthes Trochanter Stabilization Plate (TSP) for DHS (Line Extension) - MR Conditional Classification Name(s): Plate, Fixation, Bone Regulatory Class: Class II; 888.3030 Product Code(s): HRS, N/A #### 1.3. Predicate Device K002710 Modification to Synthes (USA) Trochanter Stabilization Plate (TSP) for DHS (Line Extension) ### Device Description 1.4. The DePuy Synthes TSP line extension is a shorter length version of the currently marketed TSP Plating System. It is a component of the DePuy Synthes DHS System, which fits over the sideplate of the DHS. The spoon-shaped area of the TSP, which is proximal to the shaft, resides along the greater trochanter. Four (4) screw holes in the TSP shaft line up with the screw holes of the DHS plate to accept the 4.5 mm cortex screws used for fixation to the femoral shaft. Two screw slots accommodate the DHS lag screw and the anti-rotational screw located proximal to it. DePuy Synthes Trochanter Stabilization Plate is provided both pre-sterilized by gamma radiation and nonsterile. {34}------------------------------------------------ ## 1.5. Indications for Use The DePuy Synthes Trochanter Stabilization Plate (TSP) for the Dynamic Hip Screw System is intended to to treat stable and unstable intertrochanteric, (DHS®) subtrochanteric, pertrochanteric and basilar neck fractures when used in conjunction with the DHS® System. ### Substantial Equivalence 1.6. The purpose of this submission is to add MR Conditional information to the device labeling for the Modification to Synthes (USA) Trochanter Stabilization Plate (TSP) for DHS (Line Extension). The intended use and technological characteristics of the devices remains unchanged. Non-clinical testing is provided to support the conditional safety of the Modification to Synthes (USA) Trochanter Stabilization Plate (TSP) for DHS (Line Extension) 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. {35}------------------------------------------------ Date Prepared: September 28, 2018 #### 1.1. Submitter Primary Contact: Elizabeth Jacobs Regulatory Affairs Project Leader DePuy Synthes 1301 Goshen Parkway West Chester, PA 19380 Phone: (610) 719-5768 Ejacob10@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 Proximal Humeral Nail – MR Conditional Classification Name(s): Nail, Fixation, Bone Regulatory Class: Class II; 888.3030 Product Code(s): JDS, N/A - 1.3. Predicate Device K002729 Synthes (USA) Proximal Humeral Nail #### Device Description 1.4. The DePuy Synthes Proximal Humeral Nail is an intramedullary rod that features a distal taper design. It is 150 mm in length and has holes in both the proximal and distal sections that accept locking screws. #### Indications for Use 1.5. The DePuy Synthes Proximal Humeral Nail is intended for use in fractures of the proximal humerus. {36}------------------------------------------------ # 1.6. Substantial Equivalence The purpose of this submission is to add MR Conditional information to the device labeling for the DePuy Synthes Proximal Humeral Nail. 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 Proximal Humeral Nail 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. {37}------------------------------------------------ Date Prepared: September 28, 2018 ### 1.1. Submitter Primary Contact: Elizabeth Jacobs Regulatory Affairs Project Leader DePuy Synthes 1301 Goshen Parkway West Chester, PA 19380 Phone: (610) 719-5768 Ejacob10@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 Trochanteric Fixation Nail (TFN) System – MR Conditional Classification Name(s): Rod, Fixation, Intramedullary And Accessories Regulatory Class: Class II; 888.3020 Product Code(s): HSB, HWC #### 1.3. Predicate Device K011857 Synthes (USA) Trochanteric Fixation Nail (TFN) System ### Device Description 1.4. The DePuy Synthes Trochanteric Fixation Nail (TFN) System consists of a cannulated intermedullary nail, a cannulated helical blade and cannulated nail end cap. The TFN Nail is anatomically contoured with a proximal diameter of 17 mm, tapering to a nominal diameter of 10, 11 or 12 mm. The proximal locking hole accommodates angles ranging from 125 - 135°. TFN nails are to be available in short lengths (170 - 235 mm) and long lengths (300 - 460 mm), with the long length nails available in right or left versions. The Trochanteric Fixation Nail accepts commercially available Synthes 4.9 mm Locking Bolts and/or 5.0 mm Locking Screws. {38}------------------------------------------------ ## 1.5. Indications for Use The DePuy Synthes Trochanteric Fixation Nail (TFN) System is intended to treat stable and unstable fractures of the proximal femur including pertrochanteric fractures, intertrochanteric fractures, basal neck fractures, and combinations thereof. The Long TFN is additionally indicated for subtrochanteric fractures, pertrochanteric fractures associated with shaft fractures, pathologic fractures (including prophylactic use) in both trochanteric and diaphyseal regions, long subtrochanteric fractures, proximal or distal non-unions, and revisions. ### Substantial Equivalence 1.6. The purpose of this submission is to add MR Conditional information to the device labeling for the DePuy Synthes Trochanteric Fixation Nail (TFN) 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 Trochanteric Fixation Nail (TFN) 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 nonclinical 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. {39}------------------------------------------------ Date Prepared: September 28, 2018 ### 1.1. Submitter Primary Contact: Elizabeth Jacobs Regulatory Affairs Project Leader DePuy Synthes 1301 Goshen Parkway West Chester, PA 19380 Phone: (610) 719-5768 Ejacob10@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 Retrograde/Antegrade Femoral Nail System – MR Conditional Classification Name(s): Rod, Fixation, Intramedullary And Accessories Regulatory Class: Class II; 888.3020 Product Code(s): HSB, HWC #### 1.3. Predicate Device K033618 Synthes (USA) Retrograde/Antegrade Femoral Nail System ### Device Description 1.4. The DePuy Synthes Retrograde Femoral Nail System is composed of femoral nails, spiral blades and end caps. Depending on the length of the nail may be inserted from a retrograde approach or from either a retrograde approach. Spiral blades, end caps and Synthes commercially available locking bolts and screws are used to secure the nail in the bone, preventing rotation and axial compression ### 1.5. Indications for Use The DePuy Synthes Retrograde/Antegrade Femoral Nail System is intended to stabilize fractures of the distal femur and the femoral shaft, including: - supracondylar fractures, including those with intra-articular extension; - ipsilateral hip/shaft fractures; - ipsilateral femur/tibia fractures; {40}------------------------------------------------ - femoral fractures in multiple trauma patients; - fractures proximal to total knee arthroplasty; - . fractures distal to a hip implant; - fractures in the morbidly obese; - fractures in osteoporotic bone, impending pathologic fractures; - malunions and nonunions ### Substantial Equivalence 1.6. The purpose of this submission is to add MR Conditional information to the device labeling for the DePuy Synthes Retrograde Femoral Nail 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 Retrograde/Antegrade Femoral Nail 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 nonclinical 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. {41}------------------------------------------------ Date Prepared: September 28, 2018 #### 1.1. Submitter Primary Contact: Elizabeth Jacobs Regulatory Affairs Project Leader DePuy Synthes 1301 Goshen Parkway West Chester, PA 19380 Phone: (610) 719-5768 Ejacob10@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 Lateral Entry Femoral Nail System – MR Conditional Classification Name(s): Rod, Fixation, Intramedullary And Accessories Regulatory Class: Class II; 888.3020 Product Code(s): HSB, N/A #### 1.3. Predicate Device K040336 Synthes (USA) Lateral Entry Femoral Nail System #### Device Description 1.4. The DePuy Synthes Lateral Entry Femoral Nail System is composed of cannulated femoral nails, solid 6.5 mm recon locking screws and cannulated end caps. Recon locking screws, as well as Synthes commercially available 5.0 mm and 6.0 mm locking screws, are used to secure the nail in the bone. ### Indications for Use 1.5. The DePuy Synthes Lateral Entry Femoral Nail System is intended to stabilize femoral shaft fractures, subtrochanteric fractures, ipsilateral neck/shaft fractures, impending pathologic fractures, non-unions and malunions. {42}------------------------------------------------ ## 1.6. Substantial Equivalence The purpose of this submission is to add MR Conditional information to the device labeling for the DePuy Synthes Lateral Entry Femoral Nail 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 Lateral Entry Femoral Nail 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. {43}------------------------------------------------ Date Prepared: September 28, 2018 ### 1.1. Submitter Primary Contact: Elizabeth Jacobs Regulatory Affairs Project Leader DePuy Synthes 1301 Goshen Parkway West Chester, PA 19380 Phone: (610) 719-5768 Ejacob10@its.jnj.com Alternate Contact: Thomas Shea Manager, Regulatory Affairs DePuy…
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