# K972774: Gas Plasma Sterilization

- Pathway: 510(k) (Traditional)
- Applicant: Zimmer, Inc.
- Decided: May 5, 1999 after 650 days
- Product code: JWH (Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer)
- Device class: 2
- Regulation: 21 CFR 888.3560
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Sterrad 100 Sterilization System: named in the summary without a submission number
- (no number) Gas Plasma Sterilization, DePuy, Inc.: named in the summary without a submission number
- (no number) Abtox Plazlyte™ Gas Plasma Sterilization, Abtox, Inc.: named in the summary without a submission number

## Most influential descendants
- K092443: Interface Acetabular Cup Liners (2009), 1 descendant of its own
- K171156: OMNI Anseris Hip Stem (2017), 0 descendants of its own

## 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® Acetabular System (acetabular liners) NexGen® Complete Knee Solution (articular surfaces and patellas)

Source page: https://510kreport.com/device/K972774
Methodology: https://510kreport.com/methodology