VAPORIZED HYDROGEN PEROXIDE (VHP) STERILIZATION OF UHMWPE COMPONENTS IN THE GENESIS KNEE SYSTEM, THE GENESIS II KNEE SYS

{0}------------------------------------------------ **MAR 1 5 2002** K0127 Orthopaedic Division Smith & Nephew, Inc. 1450 Brooks Rd., Memphis, TN 38116 U.S.A. 901-396-2121, For information: 1-800-821-5700 For orders and order inquiries: 1-800-238-7538 **Smith+Nephew** # 510(k) Summary of Safety and Effectiveness | Submitter's name: | Smith & Nephew, Inc., Orthopaedic Division | |-----------------------------------|------------------------------------------------------------------------------------------------------------------------------------| | Submitter's address: | 1450 Brooks Road, Memphis, TN 38116 | | Submitter's telephone number: | Direct phone: 901-399-6487 or FAX: 901-398-5146 | | Contact person: | David Henley, Senior Clinical/Regulatory Affairs Specialist | | Date summary prepared: | March 15, 2002 | | Trade or proprietary device name: | UHMWPE Components of the Genesis, the Genesis II, and the<br>Profix Knee Systems Sterilized with the VHP® Sterilization<br>Process | | Common or usual name: | Genesis, Genesis II, and Profix Knee System UHMWPE<br>Components | | Classification name: | 21 CFR 888.3560, knee joint patellofemorotibial<br>polymer/metal/polymer, semi-constrained cemented prosthesis | # Substantially Equivalent Legally Marketed Devices - The Genesis Knee System Smith & Nephew, Inc. . - The Genesis II Knee System Smith & Nephew, Inc. . - The Profix Knee System Smith & Nephew, Inc. � #### Device Description There have been no changes in indications for use, design, or material property changes to any Geness, Genesis II, or Profix Knee System UHMWPE components that will be sterilized using the VHP® process. The VHP sterilization process uses hydrogen peroxide (H2O2) vapor for sterilization Genesis Knee System, Genesis II Knee System, and Profix Knee System components (tibial articular inserts, all polyethylene tibial bases, patellar, and flex-lok pegs) manufactured from UHMWPE using the Century SL VHP® Sterilizer. Sterilization is achieved by a series of H2O2 gas injections at deep vacuum set points. Aeration of the medical devices after sterilization is conducted by a series of chamber evacuations. VHPGenPro510kSumS&E {1}------------------------------------------------ # Device Intended Use Components in the Genesis, Genesis II, and Profix Knee Systems are indicated for: 1) Rheumatoid arthritis; 2) Post-traumatic arthritis, osteoarthritis, or degenerative arthritis in older patients whose age, weight, and activity level are compatible with an adequate long-term result. 3) Failed osteotomies, unicompartmental replacement, or total knee replacement. 4) The posterior stabilized knee system is designed for use in patients in primary and revision surgery, where the anterior and posterior cruciate ligaments are incompetent and the collateral ligaments remain intact. 5) The constrained knee system is designed for use in patients in primary and revision surgeries, where the posterior cruciate ligament and one or both of the collateral ligaments (i.e. medial collateral and/or lateral collateral ligaments) are absent or incompetent. KOID + + 2012 The devices that are the subject of this premarket notification are intended for cemented use only and are for single use only. The Orthopaedic Division of Smith & Nephew, Inc. will utilize the VHP® sterilization process to terminally sterilize all orthopaedic implant components manufactured from UHMWPE material in the Genesis Knee System, the Genesis II Knee System, and the Profix Knee System (tibial articular inserts, all polyethylene tibial bases, patellae, and flex-lok pegs). # Technological Characteristics The VHP sterilization process is similar to the predicate sterilization processes listed above. Both of these predicate sterilization processes are intended to terminally sterilize orthopaedic implants/medical devices to a Sterility Assurance Level (SAL) of 10 . When compared to the VHP process, the predicate processes also have similar technological characteristics. ## Performance Characteristics The Orthopaedic Division of Smith & Nephew, Inc. has conducted numerous tests as supporting evidence that the VHP® sterilization process is qualified for sterilization of all UHMWPE orthopaedic implants in the Genesis, Genesis II, and Profix Knee Systems by demonstrating the following: - Microbicidal effectiveness of the vaporized hydrogen peroxide . - The effects of the VHP sterilization cycle on UHMWPE materials in which the . product is packaged - Process validation efforts to demonstrate that the VHP® sterilization process is effective and . reproducible resulting in a SAL of at least 100 Test results demonstrated that the VHP® sterilization process is capable of terminally sterilizing UHMWPE orthopaedic implants and verifies achievement of a SAL of 10 . The VHP sterilization process was also demonstrated to be safe, reproducible, predictable and effective in sterilizing UHMWPE orthopaedic implants packaged and sealed in Tyvek Mylar pouches. {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, symbolizing protection and care. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 MAR 1 5 2002 Mr. David Henley Senior Clinical/Regulatory Affairs Specialist Orthopedic Division Smith & Nephew, Inc. 1450 Brooks Road Memphis, Tennessee 38116 Re: K012778 Trade/Device Name: UHMWPE Components of the Genesis II, and the Profix Knee Systems 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 Dated: December 14, 2001 Received: December 17, 2001 Dear Mr. Henley: 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 for associated in 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. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 I that FDA has made a determination that your device complies with other requirements of the Act that I Dr. I has haatutes 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); good manufacturing practice requirements as set forth in the 0017; adoning (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. {3}------------------------------------------------ #### Page 2 - Mr. David Henley This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html Sincerely yours, for Mark N Milkunas Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ ### Premarket Notification Indications Enclosure 510(k) Number (if known): Kol2778 Device Name: UHMWPE Components of the Genesis, Genesis II, and Profix Knee Systems Sterilized with the VHP® Sterilization Process #### Indications for Use: Components in the Genesis, Genesis II, and Profix Knee Systems are indicated for: 1) Rheumatoid arthritis; 2) Post-traumatic arthritis, osteoarthritis, or degenerative arthritis in older patients whose age, weight, and activity level are compatible with an adequate long-term result. 3) Failed osteotomies, unicompartmental replacement, or total knee replacement. 4) The posterior stabilized knee system is designed for use in patients in primary and revision surgery, where the anterior and posterior cruciate ligaments are incompetent and the collateral ligaments remain intact. 5) The constrained knee system is designed for use in patients in primary and revision surgeries, where the posterior cruciate ligament and one or both of the collateral ligaments (i.e. medial collateral and/or lateral ligaments) are absent or incompetent. The devices that are the subject of this premarket notification are intended for cemented use only and are for single use only. The Orthopaedic Division of Smith & Nephew, Inc. will utilize the VHP sterilization process to terminally sterilize all orthopaedic implant components manufactured from UHMWPE material in the following product systems: - . Genesis Knee System (i.e. tibial articular inserts, all polyethylene tibial bases, patellac, and flex-lok pegs) - Genesis II Knee System (i.e. tibial articular inserts, all polyethylene tibial bases, patellae, and flex-lok ● pegs) - . Profix Knee System (i.e. tibial articular inserts, all polyethylene tibial bases, patellae) #### (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) I. Mach A Milken Division of General, Restorative and No ological Devices 510(k) Number _ Prescription Use (Per 21 CFR 801.109) OR Over-the-Counter Use (Optional Format 1-2-96)