VANGUARD XP FEMORAL COMPONENT(GEN II)/VANGUARD XP FEMORAL TRIAL

{0}------------------------------------------------ Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 October 27, 2014 Biomet, Incorporated Ms. Julie B. Gantenberg, M.S., RAC Senior Regulatory Affairs Specialist 56 East Bell Drive Warsaw, Indiana, 46581 Re: K141407 Trade/Device Name: Vanguard XP Knee System Regulation Number: 21 CFR 888.3565 Regulation Name: Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis Regulatory Class: Class II Product Code: MBH, JWH, MBV, OIY Dated: September 29, 2014 Received: October 1, 2014 Dear Ms. Gantenberg: 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 {1}------------------------------------------------ Page 2 - Ms. Julie B. Gantenberg, M.S. (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 (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/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 yours, 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}------------------------------------------------ ## narket Notification [510(k)] Submission, 21 CFR § 807.87 Vanguard XP Knee System Traditional #### Indications for Use K141407 510(k) Number (if known): Device Name: Vanguard XP Knee System Indications For Use: - 1. Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, or traumatic arthritis where one or more compartments are involved. - 2. Correction of varus, valgus, or posttraumatic deformity. - Correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous total 3. joint replacement procedure. Femoral components and tibial tray components with porous coatings are indicated for cemented and uncemented biological fixation application. Non-coated (Interlok) femoral components, tibial tray components and all polyethylene patellar components are indicated for cemented application only. Regenerex components* are intended only for uncemented biologic fixation application. *Where Available Prescription Use X Over-The-Counter Use AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Paqe 1/1 {3}------------------------------------------------ #### K141407 510(k) SUMMARY A summary of 510(k) safety and effectiveness information in accordance with the requirements of 21 CFR 807.92 | Submitter Information | | |------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Name | Biomet Manufacturing Corp. | | Address | 56 East Bell Drive<br>Warsaw, IN 46581-0857 | | Phone number | (574) 267-6639 | | Fax number | (574) 371-1027 | | Establishment<br>Registration Number | 1825034 | | Name of contact<br>person | Julie B. Gantenberg, M.S., RAC | | Date prepared | September 29, 2014 | | Name of device | | | Trade or proprietary<br>name | Vanguard XP Knee System | | Common or usual<br>name | Knee Prosthesis | | Classification name | Knee joint patellofemorotibial metal/polymer porous- coated<br>uncemented prosthesis (§888.3565)<br>Knee joint patellofemorotibial polymer/metal/polymer semi-<br>constrained cemented prosthesis (§888.3560)<br>Knee joint patellofemorotibial semi-constrained UHMWPE<br>pegged uncemented polymer/metal/polymer (§888.3560)<br>Knee joint patellofemorotibial polymer+Additive/metal/polymer<br>+Additive semi-constrained cemented prosthesis (§888.3560) | | Classification panel | Orthopedic | | Regulation | 21CFR §888.3565<br>21CFR §888.3560 | | Product Code(s) | JWH, MBH, MBV, OIY | | Legally marketed device(s)<br>to which equivalence is<br>claimed | K132873 Vanguard XP Knee System (JWH, MBH, MBV, OIY)<br>K122160 Vanguard XP Knee System (JWH, MBH, MBV, OIY)<br>K113550 Vanguard Knee System (JWH, MBH, OIY)<br>K904448 Townley Total Knee (JWH) | | Reason for 510(k)<br>submission | Line Extension of XP Femoral Component | Mailing Address: P.O. Box 587 Warsaw, IN 46581-0587 Toll Free: 800.348.9500 Office: 574.267.6639 Main Fax: 574.267.8137 www.biomet.com Shipping Address: 56 East Bell Drive Warsaw, IN 46582 {4}------------------------------------------------ # BIOMET | Device description | The purpose of the submission is a line extension of the Vanguard<br>XP femoral component. The Vanguard XP femoral component is<br>now compatible with the standard Vanguard bearings components<br>when using Vanguard tibial trays. | |----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | The Vanguard XP Knee System is a total knee replacement<br>system that consists of a femoral component composed of Co-Cr-<br>Mo, two styles of tibial trays/plates manufactured of Co-Cr-Mo<br>(with locking bar), and dual bearings machined of E1 poly.<br>Biomet patellae can be used with the Vanguard XP Knee System.<br>Both the XP femoral and the XP-CR tibial components are<br>available with a previously cleared porous plasma spray (PPS)<br>coating of titanium alloy and Biomet's Interlok coarse blasted<br>finishes. The Vanguard XP-XP tibial components are available in<br>Biomet's Interlok coarse blasted finish. Porous coated femoral<br>and tibial components are indicated for cemented and uncemented<br>biological fixation application. Non-coated coarse blasted<br>(Interlok) femoral and tibial components are indicated for<br>cemented application only. Accessory components are available<br>including removable femoral pegs and femoral augments. | | Intended use of the device | The Vanguard XP Knee System is intended for replacement of a<br>total knee joint and the preservation of the anterior and/or posterior<br>cruciate ligament (ACL/PCL) when used in conjunction with a<br>femoral, tibial and patellar component. | | Indications for use | 1. Painful and disabled knee joint resulting from osteoarthritis,<br>rheumatoid arthritis, or traumatic arthritis where one or more<br>compartments are involved.<br>2. Correction of varus, valgus, or posttraumatic deformity.<br>3. Correction or revision of unsuccessful osteotomy, arthrodesis,<br>or failure of previous total joint replacement procedure.<br><br>Femoral components and tibial tray components with porous<br>coatings are indicated for cemented and uncemented biological<br>fixation application. Non-coated (Interlok) femoral components,<br>tibial tray components and all polyethylene patellar components are<br>indicated for cemented application only. Regenerex components*<br>are intended only for uncemented biologic fixation application.<br>*where available | {5}------------------------------------------------ The Vanguard XP Knee System is made up of multiple components, including: instrumentation, femoral components, several types of bearings and tibial travs. The technological characteristics of the Vanguard XP Knee System are the same as those of predicate devices (K132873/K122160 and K113550) in terms of design, material, and principle of operation with the exception of slight modifications as described in this 510(k). The subject Vanguard XP femur modifications utilize the identical manufacturing processes as the predicates. The previously cleared, porous plasma spray characterization data on identical substrate was provided in K113550 and used in support of subject 510(k). The porous plasma spray coating on the ASTM F75 substrate is for both cemented and uncemented, biologic fixation. Previous P/F contact area and stability testing were provided in support of unchanged P/F articulating geometry. The subject non-clinical testing was conducted to demonstrate that the differences did not adversely affect safety and efficacy, and to demonstrate substantial equivalence to the predicate components. All testing met or exceeded the established acceptance criteria. This information is detailed below in the Performance (Non-clinical) section. #### PERFORMANCE DATA ### SUMMARY OF NON-CLINICAL TESTS #### Performance Test Summary-New Device The following tests/rationale were performed for the Vanguard XP Knee System line extension: - Wear - T/F Constraint - T/F Contact Area ● - P/F Joint Analysis ● - Range of Motion - Bearing Fatigue - Surface Roughness of metallic femoral component - Femoral Section Analysis - MRI Compatibility Rationale ● #### SUMMARY OF CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE AND/OR OF CLINICAL INFORMATION Clinical Performance Data/Information: N/A #### CONCLUSIONS DRAWN FROM NON-CLINICAL AND CLINICAL DATA No clinical testing was necessary for a determination of substantial equivalence. The results of mechanical testing indicated the devices performed within the intended use, did not raise any new safety and efficacy issues and were found to be substantially equivalent to the predicate devices.