Y3 Proximal Femoral Plate System

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name encircling a symbol of three stylized human profiles facing right. The profiles are stacked on top of each other, creating a sense of depth and unity. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 March 16, 2017 Pega Medical Inc. Ariel Dujovne President 1111 Autoroute Chomedey Laval, Ouebec, CA H7W 5J8 Re: K163003 Trade/Device Name: Y3 Proximal Femoral Plate System 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 Dated: February 7, 2017 Received: February 9, 2017 Dear Ariel Dujovne: 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. 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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in {1}------------------------------------------------ the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely, # Lori A. Wiggins -S for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ #### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration ## Indications for Use 510(k) Number (if known) K163003 Device Name Y3 Proximal Femoral Plate System Indications for Use (Describe) The Y 3 Proximal Femoral Plate System is intended for the temporary internal fixation of fractures and osteotomies of the greater trochanter or of the proximal femur. It is indicated for the following: - · Re-attachment of the greater trochanter following osteotomy in THA - · Trochanteric and intertrochanteric fractures - · Extended trochanteric osteotomy - · Periprosthetic femoral fractures - · Comminuted fractures - · Mal-unions and non-unions - · Fractures in osteopenic bone 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 "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ ## 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS ## Applicant : Contact Person : Proprietary Name : Common Name : Device Classification : Classification Name : #### Device Product Code : Establishment Registration Number : Pega Medical Inc. 1111 Highway Chomedey Laval, Quebec, Canada, H7W 5J8 Phone : 1-877-739-5175 Fax : 1-888-258-0760 Ariel R. Dujovne Y3 Proximal Femoral Plate System Fracture fixation Plate Class II Single/Multiple Component Metallic Bone Fixation Appliances And Accessories (21 CFR 888.3030) HRS, HWC 9048931 #### Intended Use: The Y3 Proximal Femoral Plate System is intended for the temporary internal fixation of fractures and osteotomies of the greater trochanter or of the proximal femur. It is indicated for the following: - Re-attachment of the greater trochanter following osteotomy in THA - Trochanteric and intertrochanteric fractures - Extended trochanteric osteotomy ● - o Periprosthetic femoral fractures - Comminuted fractures ● - Mal-unions and non-unions - Fractures in osteopenic bone ● ## Description: The Y3 Proximal Femoral Plate System is an innovative fixation device intended for the treatment of proximal femoral fractures and osteotomies. The unique Y-shape design divides the proximal portion of the plate into anterior and posterolateral branches, thus intended for stability at the Greater Trochanter level both in rotation and translation while reducing the prominence of the implant. Fixation options include locking and non-locking screws in addition to cerclage cables. The Y3 Proximal Femoral Plate System is manufactured in medical grade Titanium Alloy Ti-6AI-4V ELI as per ASTM F136. The Y3 Proximal Femoral Plate System is available in four lengths: 135, 185, 235 and 285 mm. Left and right versions are offered to accommodate the anatomical shape of the proximal femur. {4}------------------------------------------------ ### Basis for substantial equivalence: The Y3 Proximal Femoral Plate System is claimed to be substantially equivalent in design, indicated use and function to the following predicate devices: | | Primary<br>Predicate Device | Additional Predicate<br>Device | Reference Device | |----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------|----------------------------------| | Device Name | NCB Periprosthetic Trochanter Plates and<br>Screws, NCB Cable Button for NCB Polyaxial<br>Locking Plate<br>in combination with the<br>NCB Periprosthetic Femur Polyaxial Locking<br>Plate System | Cable-Ready<br>Cable Grip<br>System | Gap Endo-Exo<br>Medullary System | | Marketed by | Zimmer, GmbH | Zimmer, Inc. | Pega Medical Inc. | | FDA 510(k)<br>number | K120772 | K151907 | K160545 | ## Summary of Technologies: The technological characteristics of the Y3 Proximal Femoral Plate System are the same or similar to the ones of the predicate devices. Both the Y3 Proximal Femoral Plate System and the NCB Periprosthetic Trochanter System use screws a primary fixation system. Both use 3.5mm screws for trochanteric fixations. For diaphyseal fixation, the Y3 Plate offers 4.5mm screws, while the NCB System proposes 4.0mm and 5.0mm screws. The Y3 Plate is made of Titanium TiAl6V4 ELI Alloy and the NCB System is made of Titanium TiAl6V4 Alloy. ## Non-clinical Performance Data: Verification calculations were completed to evaluate resistance of the Y3 Proximal Femoral Plate System in comparison to the Cable-Ready Cable Grip System and NCB Periprosthetic Trochanter System. The mechanical properties of all the screw components of the system were analysed in comparison to the predicate systems. Furthermore, stresses on the plate during were evaluated to ensure proper resistance of the system. Finally, the bench testing of the Y3 Proximal Femoral Plate System in static and fatique confirmed the validity of these calculations. Results of the static and fatique bench testing on the Y3 Proximal Femoral Plate System and NCB system have demonstrated that the Y3 Proximal Femoral Plate System performed equivalently to the predicate NCB system. Finally, a systematic search of the scientific literature was carried out and a Clinical Evidence Review report was issued. This report intentify and analyze the published peer-reviewed scientific literature regarding trochanteric fixation in general, and more specifically of the two predicate systems, in order to establish substantial equivalence of the Y3 Proximal Femoral Plate System by addressing the clinical hazards identified in the device Risk Analysis. {5}------------------------------------------------ As per the findings of the bench testing and the scientific literature review, the data supports the substantial equivalence of the subject device. The Y3 Proximal Femoral Plate System is substantially equivalent in bending compared to the NCB Periprosthetic Trochanter System. The stiffness and the Yield point of the Y3 Plate (slope) are respectively 49,5 N/mm and 536.6N compared to 25.3 N/mm and 303.4N for the predicate. Consequently, the Y3 Plate is 1.96 times stiffer and the yield is 1.77 times higher than the predicate. The compression bending strength at vield of the Y3 Plate is 34.6 Nm, which is 1.6 higher than the 21.3Nm of the predicate. The Y3 Proximal Femoral Plate System plate reduces greater trochanter anterior migration in cadaveric models. During a biomechanical hip extension study, multi-directional greater trochanter fragment movements occurred and showed a back-and-forth anterior rotation. The lateral locking plate failed due to greater trochanter fragment rotation around the superior axis and anterior translation. The antero-lateral locking plate significantly reduced greater trochanter anterior migration (-0.9 mm ± 1.6) compared to the lateral locking plate (9.6 mm ± 9.5). [Cloutier, L. P., Laflamme, G. Y., Menard, J., & Petit, Y. (2014). Anterior locking plate reduces trochanteric fracture migrations during hip extension. Clinical Biomechanics, 29(8), 930-935.] #### Clinical Performance Data: No clinical testing is provided as a basis for substantial equivalence. #### Conclusion: Based on the similarities in the intended use, design, materials, manufacturing methods, and packaging, the Y3 Proximal Femoral Plate System has been established as substantially equivalent to the previously cleared predicate devices. Furthermore, mechanical evaluation results demonstrate that the proposed system is substantially equivalent to the predicate devices.