ZIMMER(R) PERSONA THE PERSONALIZED KEE SYSTEM 14X +30MM TAPERED STEM EXTENSION

{0}------------------------------------------------ K133737 FEB - 4 2014 ## Summary of Safety and Effectiveness | Sponsor: | Zimmer, Inc. P.O. Box 708 Warsaw, IN 46581-0708 | |-----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Contact Person: | Pauline A. Shand Associate Project Manager, Regulatory Affairs Telephone: (574) 372-4765 Fax: (574) 372-4605 | | Date: | January 24, 2014 | | Trade Name: | Zimmer® Persona The Personalized Knee System 14 x+30mm Tapered Stem Extension | | Product Codes / Device: | JWH, OIY | | Regulation Numbers / Description: | 21 CFR § 888.3560 - Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented | | Predicate Device: | Persona Personalized Knee System (K113369, cleared March 27, 2012) | | | M-G II® Total Knee System Stemmed Tibial Baseplate Components (K050723, cleared April 20, 2005) | | | NexGen® Complete Knee Solution (K933785, cleared January 30, 1995) | | Device Description: | The Persona 14 x+30mm Tapered Stem Extension is intended for implantation for total knee arthroplasty (TKA) when supplemental tibial baseplate support is needed. Extending into the intramedullary canal from the base of | Image /page/0/Picture/5 description: The image shows the text "510(k) Summary Page 1 of 3 January 28, 2014". The text indicates that the image is the first page of a 510(k) summary document. The document is dated January 28, 2014. The document is 3 pages long. Image /page/0/Picture/6 description: The image shows the logo for Zimmer. The logo consists of a circle with a stylized letter Z inside it. Below the circle is the word "zimmer" in a sans-serif font. {1}------------------------------------------------ Intended Use: from excessive stress by resisting bending and torsional moments. The subject device is intended to be used with cement knee constructs. the Persona Cemented Stemmed Tibia Baseplate, the supplemental support and shields the fixation interfaces Persona 14 x+30mm Stem Extension provides This device is indicated for patients with severe knee pain and disability due to: - Rheumatoid arthritis, osteoarthritis, traumatic arthritis, ﺳ polyarthritis. - Collagen disorders, and/or avascular necrosis of the | femoral condyle. - । Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy. - ﺴﺖ Moderate valgus, varus, or flexion deformities. - The salvage of previously failed surgical attempts or for a knee in which satisfactory stability in flexion cannot be obtained at the time of surgery. This device is intended to be used with cemented knee constructs. Comparison to Predicate Device: The proposed Zimmer® Persona The Personalized Knee System 14 x+30mm Tapered Stem Extension is similar or identical in intended use, materials, sterility, and performance characteristics to the predicate devices. Performance Data (Nonclinical and/or Clinical): Clinical Performance and Conclusions: Clinical data and conclusions were not needed for this device. Non-Clinical Performance and Conclusions: Bench testing outlined below was conducted according to FDA guidance documents: FDA Guidance: Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and {2}------------------------------------------------ 510(k) Summary Page 3 of 3 January 28, 2014 Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses FDA Guidance: Guidance document for testing nonarticulating, "mechanically locked", modular implant components. FDA Guidance: Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone or Bone Cement | Property or<br>Characteristic | Test Results | |-------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Fatigue Test of the <i>Persona</i> Tibia<br>Keel and Stem Extension | Demonstrated that the <i>Persona</i> tibia keel and stem extension<br>taper junction has sufficient fatigue strength to survive<br>expected worst case loading conditions. | | Static Axial and Torsional Strength<br>of the <i>Persona</i> Stem Extension<br>Taper | Demonstrated the static axial and torsional strength of the<br><i>Persona</i> stem extension taper mechanism. | | The Risk of Cortex Perforation for<br><i>Persona</i> Tibial Components with<br>+30MM Stem | Assessed the potential risk of cortex perforation of the<br><i>Persona</i> stemmed tibial implant with the 14 x +30mm stem<br>extension compared to the <i>NexGen</i> tibial implant when<br>implanted in the same manner. | {3}------------------------------------------------ DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the bird symbol. The text is in all caps and appears to be in a sans-serif font. #### Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 #### February 4, 2014 Zimmer, Incorporated % Ms. Pauline A. Shand Associate Project Manager, Regulatory Affairs Zimmer, Incorporated P.O. Box 708 Warsaw, Indiana 46581 Re: K133737 Trade/Device Name: Zimmer® Persona The Personalized Knee System 14 x+30mm Tapered Stem Extension Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: JWH, OIY Dated: December 6, 2013 Received: December 9, 2013 Dear Ms. Shand: 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 {4}------------------------------------------------ ### Page 2 - Ms. Pauline A. Shand 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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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 Small Manufacturers, International and Consumer Assistance at its tollfree 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Sincerely vours. # Vincen伺服@evlin -S for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {5}------------------------------------------------ ### Indications for Use ### 510(k) Number (if known): K133737 ### Device Name: Zimmer® Persona The Personalized Knee System 14 x+30mm Tapered Stem Extension #### Indications for Use: This device is indicated for patients with severe knee pain and disability due to: - Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis. ー - । Collagen disorders, and/or avascular necrosis of the femoral condyle. - Post-traumatic loss of joint configuration, particularly when there is patellofemoral ﺍ erosion, dysfunction or prior patellectomy. - | Moderate valgus, varus, or flexion deformities. - The salvage of previously failed surgical attempts or for a knee in which satisfactory ----stability in flexion cannot be obtained at the time of surgery. This device is intended to be used with cemented knee constructs. Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 807 Subpart C) (Please do not write below this line - Continue on another page if needed) ### Concurrence of CDRH, Office of Device Evaluation (ODE) Casey L. Hanley, Ph.D. Division of Orthopedic Devices Page 1 of 1