Zimmer M/L Taper Hip Prosthesis

{0}------------------------------------------------ February 28, 2020 Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. Zimmer, Inc. Caleb Barylski Specialist, Regulatory Affairs 1800 W. Center Street Warsaw, Indiana 46580 Re: K192660 Trade/Device Name: Zimmer M/L Taper Hip Prosthesis Regulation Number: 21 CFR 888.3353 Regulation Name: Hip Joint Metal/Ceramic/Polymer Semi-Constrained Cemented Or Nonporous Uncemented Prosthesis Regulatory Class: Class II Product Code: LZO, MEH Dated: January 29, 2020 Received: January 30, 2020 Dear Caleb Barylski: 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. 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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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Vesa Vuniqi, MS Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K192660 Device Name Zimmer M/L Taper Hip Prosthesis #### Indications for Use (Describe) Total hip replacement for the following: severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head, nonunion of previous fractures of the femur; congenital hip dysplasia, protrusio acetabuli, slipped capital femoral epiphysis: disability due to previous fusion; previously failed endoprostheses, and/or total hip components in the affected extremity and acute femoral neck fractures. Hemi-hip replacement for the following: fracture dislocation of the hip; elderly, debilitated patients when a total hip replacement is contraindicated; irreducible fractures in which adequate fixation cannot be obtained; certain high subcapital fractures and comminuted femoral neck fractures in the aged; nonumon of femoral neck fractures; secondary avascular necrosis of the femoral head; pathological fractures of the femoral neck; and osteoarthritis in which the femoral head is primarily affected. The femoral stem is for cementless use only. | 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 "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 In accordance with 21 CFR §807.92 and the Safe Medical Devices Act of 1990, the following information is provided for the VerSys Cemented Revision/Calcar 510(k) premarket notification. The submission was prepared in accordance with the FDA guidance document, 'Format for Traditional and Abbreviated 510(k)s,' issued on September 13, 2019. | Sponsor: | Zimmer, Inc.<br>P.O. Box 708<br>Warsaw, IN 46581-0708<br>Establishment Registration Number: 1822565 | | | |----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------|-------------| | Contact Person: | Caleb Barylski<br>Regulatory Affairs Specialist<br>Telephone: (574) 371-0250 | | | | Date: | 27 February 2020 | | | | Subject Device: | Trade Name: Zimmer M/L Taper Hip Prosthesis<br>Common Name: Hip Prosthesis | | | | | Classification Name:<br>• LZO - Prosthesis, Hip, Semi-Constrained,<br>Metal/Ceramic/Polymer, Cemented or Non-Porous,<br>Uncemented (21 CFR 888.3353 Hip joint<br>metal/ceramic/polymer semi-constrained cemented on<br>nonporous uncemented prosthesis)<br>• MEH - Prosthesis, Hip, Semi-Constrained,<br>Uncemented, Metal/Polymer, Non-Porous, Calcium-<br>Phosphate (21 CFR 888.3353 Hip joint<br>metal/ceramic/polymer semi-constrained cemented on<br>nonporous uncemented prosthesis) | | | | Predicate Device(s): | K032726 | ZIMMER M/L<br>TAPER HIP<br>PROSTHESIS,<br>7711 SERIES | Zimmer, Inc | | | K042337 | ZIMMER M/L<br>TAPER HIP<br>PROSTHESIS<br>WITH<br>CALCICOAT<br>CERAMIC<br>COATING | Zimmer, Inc | | | K060040 | ZIMMER M/L | Zimmer, Inc | {4}------------------------------------------------ Device Description The Zimmer M/L Taper Hip Prosthesis is a modular, titanium alloy femoral stem designed to replace the proximal femur in total hip arthroplasty. It is flat, collarless and features a proximal-to-distal taper in the mediolateral (M/L) plane. The wedge shaped prosthesis is designed for cementless use and is circumferentially coated with titanium alloy plasma spray over the proximal body region. A subset of the subject devices are coated with Calcicoat hydroxyapatite tricalcium phosphate coating (HA/TCP) over the coating. Indications for Use: Total hip replacement for the following: severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head, nonunion of previous fractures of the femur; congenital hip dysplasia, protrusion acetabuli, slipped capital femoral epiphysis; disability due to previous fusion: previously failed endoprostheses, and/or total hip components in the affected extremity and acute femoral neck fractures. Hemi-hip replacement for the following: fracture dislocation of the hip: elderly, debilitated patients when a total hip replacement is contraindicated; irreducible fractures in which adequate fixation cannot be obtained; certain high subcapital fractures and comminuted femoral neck fractures in the aged; nonunion of femoral neck fractures; secondary avascular necrosis of the femoral head; pathological fractures of the femoral neck; and osteoarthritis in which the femoral head is primarily affected. The femoral stem is for cementless use only. Summary of Technological The rationale for substantial equivalence is based on Characteristics: consideration of the following characteristics: Intended Use: Identical ● Indications for Use: Identical ● Materials: Substantially Equivalent ● ● Design Features: Substantially Equivalent . Sterilization: Identical {5}------------------------------------------------ ### Summary of Performance Data (Nonclinical and/or Clinical) ## Non-Clinical Tests: - Performance Evaluation Performance testing o was completed on the Zimmer M/L Taper Hip Prosthesis line extensions to determine equivalence to legally marketed devices. - Compatibility Fatigue testing and range of O motion testing was conducted to show compatibility and safe and effective use with acquired devices. #### Clinical Tests: - o Clinical test data is not provided for the subject device. Substantial Equivalence Conclusion The data presented in this submission demonstrate that the changes do not affect the safety and/or effectiveness of the subject devices and that the subject devices perform in a substantially equivalent manner to the legally marketed predicate devices.