VAPORIZED HYDROGEN PEROXIDE (VHP) STERILIZATION OF UNMWPE COMPONENTS IN THE COFIELD TOTAL SHOULDER SYSTEM, THE NEER II

{0}------------------------------------------------ K012788 10F2 MAR 1 5 2002 #### Orthopaedic Division Smith & Nephew, Inc. 1450 Brooks Rd., Memphis, TN 38116 901-396-2121, For information: 1-8 orders and order incomes: 1-80 # 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 Cofield2, the Neer II, and the<br>Neer III Total Shoulder Systems Sterilized with the VHP®<br>Sterilization Process | | Common or usual name: | Cofield2, Neer II, and Neer III Total Shoulder System<br>UHMWPE Components | | Classification name: | 21 CFR 888.3660, shoulder joint metal/polymer, semi-<br>constrained cemented prosthesis | ### Substantially Equivalent Legally Marketed Devices - Cofield Total Shoulder System Smith & Nephew, Inc. � - Neer II Total Shoulder System Smith & Nephew, Inc. . - Neer III Total Shoulder System Smith & Nephew, Inc. � ### Device Description There have been no changes in indications for use, design, or material property changes to any Cofield2, Neer II, or Neer III Total Shoulder System UHMWPE all polyethylene glenoid components that will be sterilized using the VHP® process. The VHP sterilization process uses hydrogen peroxide (H2O2) vapor for sterilization of Coffeld2, Neer II, and Neer III Total Shoulder System components (all polyethylene glenoids) 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. ### Device Intended Use VHPCofNIN3510kSumS&E {1}------------------------------------------------ The Cofield2 Total Shoulder System, the Neer II Total Shoulder System, and the Neer III Total Shoulder System are indicated for use as orthopaedic implants for the partial or total replacement of the human shoulder joint articulating either directly against the glenoid face or a compatible glenoid component, respectively. The Cofield2 Total Shoulder System, the Neer II Total Shoulder System, and the Neer III Total Shoulder System are intended for the following: Proximal Humeral Prosthesis -- (1) complex, acute fractures or fracture-dislocations of the humeral head (e.g. trauma - three and four-part injuries in the Neer classification, or head splitting, or head impression fractures); (2) complex, chronic fractures or fracture-dislocations of the humeral head with malunion, nonumion of a small osteoporotic head fragment, or chronic dislocation with loss of humeral head cartilage, or large impression fractures; (3) avascular necrosis with intact glenoid cartilage; and (4) selected patients with arthritis who do not have adequate scapular bone to support a glenoid component or must engage in moderately heavy activities. Total Shoulder Arthroplasty (when used in conjunction with a compatible glenoid component) - severe I out Dion of the glenohumeral articular surfaces with intractable chronic pain in rheumatoid arthritis, asteoarthritis, traumatic arthritis, cuff tear arthroplasty, ancient septic arthritis avascular necrosis with scoondary glenoid changes, radiation necrosis, and other failed reconstructive procedures. The subject all poly glenoid components are intended for cemented fixation only and for single use only. The Orthopaedic Division of Smith & Nephew, Inc. will utilize the VHP® sterilization process to term ally sterilize all orthopaedic implant components manufactured from UHMWPE material in the Cofield Total Shoulder System, the Neer II Total Shoulder System, and the Neer III Total Shoulder System (all polyethylene glenoids). ### 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 Coffeld', Neer II, and Neer III Total Shoulder 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 10-6 Test results demonstrated that the VHP® sterilization process is capable of terminally sterilizing UHMWPE orthopaedic implants and verifies achievement of a SAL of 10d. 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. 1012788 20F2 {2}------------------------------------------------ Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the symbol. The caduceus is positioned in the center of the logo, with the text encircling it. 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: K012788 Trade/Device Name: UHMWPE Components of the Cofield, the Neer II, and the Neer III Total Shoulder Systems Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder Joint Metal/Polymer, Semi-constrained Cemented Prosthesis Regulatory Class: Class II Product Code: KWS 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 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. 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 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); 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. {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, Sincerely yours, Mark A Milken 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): Ko127888 Device Name: UHMWPE Components of the Cofield', Neer III Total Shoulder Systems Sterilized with the VHP® Sterilization Process #### Indications for Use: The Cofield' Total Shoulder System, the Neer II Total Shoulder System, and the Neer III Total Shoulder System are indicated for use as orthopaedic implants for the partial replacement of the human shoulder joint articulating either directly against the glenoid face or a compatible glenoid component, respectively. The Cofield2 Total Shoulder System, the Neer II Total Shoulder System, and the Neer III Total Shoulder System are intended for the following: Proximal Humeral Prosthesis - (1) complex, acute fractures or fracture-dislocations of the humeral head (e.g. trauma - three and four-part injuries in the Neer classification, or head splitting, or head impression fractures); (2) complex, chronic fractures or fracture-dislocations of the humeral head with malunion, nonunion of a small osteoporotic head fragment, or chronic dislocation with loss of humeral head cartilage, or large impression fractures; (3) avascular necrosis with intact glenoid cartilage; and (4) selected patients with arthritis who do not have adequate scapular bone to support a glenoid component or must engage in moderately heavy activities. Total Shoulder Arthroplasty (when used in conjunction with a compatible glenoid component) - severe destruction of the glenohumeral articular surfaces with intractable chronic pain in rheumatoid arthritis, osteoarthritis, traumatic arthritis, cuff tear arthroplasty, ancient septic arthritis avascular necrosis with secondary glenoid changes, radiation necrosis, and other failed reconstructive procedures. The subject all poly glenoid components are intended for cemented fixation only and for single use only. The Orthopaedic Division of Smith & Nephew, Inc. will utilize the VHP® sterilization process to terminally sterilize all polyethylene glenoid components manufactured from UHMWPE material in the following product systems: - Cofield Total Shoulder System (all polyethylene glenoid components) . - Neer II Total Shoulder System (all polyethylene glenoid components) . - Neer III Total Shoulder System (all polyethylene glenoid components) � #### (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) for (Division Sign-Off) Division of General, Restorative and Neurological Devices 510(k) Number K012788 Prescription Use CFR 801.109) OR Over-the-Counter Use (Optional Format 1-2-96) (Per 21