GAS PLASMA STERILIZATION

K972774 · Zimmer, Inc. · JWH · May 5, 1999 · Orthopedic

Device Facts

• Record ID: K972774
• Device Name: GAS PLASMA STERILIZATION
• Applicant: Zimmer, Inc.
• Product Code: JWH · Orthopedic
• Decision Date: May 5, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3560
• Device Class: Class 2

Intended Use

Gas Plasma Sterilization is intended to be used for terminal sterilization of all Zimmer Ultra-High Molecular-Weight Polyethylene (UHMWPE) products as follows: - Trilogy Acetabular System (acetabular liners) - NexGen® Complete Knee Solution (articular surfaces and patellas)

Device Story

Gas Plasma Sterilization process for terminal sterilization of Zimmer UHMWPE orthopedic implants; specifically Trilogy Acetabular System liners and NexGen Complete Knee Solution articular surfaces and patellas. Process utilizes gas plasma technology to achieve sterility assurance level (SAL) of 10^-6. Device is used in manufacturing/processing environment to ensure product sterility prior to clinical use. Output is a sterilized medical device ready for surgical implantation. Benefits include reduction of bioburden on UHMWPE components while maintaining material integrity.

Clinical Evidence

Bench testing only. Sterilization validation completed to verify achievement of a sterility assurance level (SAL) of 10^-6.

Technological Characteristics

Gas plasma sterilization system. Process designed for UHMWPE materials. Achieves SAL of 10^-6. No specific software, connectivity, or mechanical dimensions provided; system relies on gas plasma chemical/physical interaction for sterilization.

Indications for Use

Indicated for terminal sterilization of Zimmer Ultra-High Molecular-Weight Polyethylene (UHMWPE) products, specifically Trilogy Acetabular System acetabular liners and NexGen Complete Knee Solution articular surfaces and patellas.

Regulatory Classification

Identification

A knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a knee joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components and a retropatellar resurfacing component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).

Predicate Devices

• Sterrad 100 Sterilization System, Advanced Sterilization Products
• Gas Plasma Sterilization, DePuy, Inc.
• Abtox Plazlyte™ Gas Plasma Sterilization, Abtox, Inc.

Submission Summary (Full Text)

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Image /page/0/Picture/3 description: The image shows the logo for Zimmer Inc. The logo features a large, stylized letter Z inside a circle. Below the circle, the word "zimmer" is written in a bold, sans-serif font. The date 5/5/99 is written at the top right of the logo.

K972774
Box 708

P.O. Box 708 Warsaw, IN 46581-0708 219 267-6131

# Summary of Safety and Effectiveness Gas Plasma Sterilization

#### Submitted by: .

Zimmer, Inc. P.O. Box 708 Warsaw, IN 46581-0708

- Prepared by: .
Theodore M. Wendt, Ph.D. Vice President Regulatory and Clinical Affairs Telephone: [phone] Telefax: 219-372-4605

- Date: ●
April 27, 1999

- Trade Name: .
Gas Plasma Sterilization

- Common Name: ▲
Gas Plasma Sterilization

- Classilication Name: t
Sterilizer

- Predicate Devices: t
Sterrad 100 Sterilization System, Advanced Sterilization Products Gas Plasma Sterilization, DePuy, Inc. Ahtox Plazlyte™ Gas Plasma Sterilization, Abtox, Inc.

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# Summary of Safety and Effectiveness Gas Plasma Sterilization (Continued)

Device Description l Sterrad 100 Sterilization System

- . Intended Use
Gas Plasma Sterilization is intended to be used for terminal sterilization of all Zimmer Ultra-High Molecular-Weight Polyethylene (UHMWPE) products as follows:

- . Trilogy Acetabular System (acetabular liners)
- NexGen® Complete Knee Solution (articular surfaces and patellas) .

# Performance Testing/Sterilization Validation

A sterilization validation was completed and verifies achievement of a sterility assurance level (SAL) of 10%.

RA07703K.510

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Image /page/2/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a stylized image of an eagle's head with three lines representing the feathers. The eagle's head is facing to the left. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle's head.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

5 1099 MAY

T.M. Wendt, Ph.D. Vice President Regulatory and Clinical Affairs Zimmer, Inc. P.O. Box 708 46581-0708 Warsaw, Indiana

K972774 Re: STERRAD Gas Plasma Sterilization of Trilogy Trade Name: acetabular Liners and NexGen Articulator Surfaces (Tibial Trays) and Patellae Regulatory Class: II Product Codes: JWH, LPH, and MLR April 14, 1999 Dated: Received: April 16, 1999

Dear Dr. Wendt:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - T.M. Wendt, Ph.D.

This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Celia M. Witten, Ph.D.

ia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page 1 of 1

7 4 510(k) Number (if known): K 9 7 2

Device Name: Gas Plasma Sterilization

Indications For Use:

Gas Plasma Sterilization is intended to be used for terminal sterilization of all Zimmer Ultra-High Molecular-Weight Polyethylene (UHMWPE) products as follows:

- Trilogy® Acctabular System (acctabular liners) .
- t Nex Gento Complete Knee Solution (articular surfaces and patellas)

# (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

# Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use _X (Per 21 CFR 801.109)

OR

Over-The-Counter Use (Optional Format 1-2-96)

pcöééé

(Division Sign-Off)
Division of General Restorative Device K97277
510(k) Number

RA04901C.MS