# K962196: Nexgen Knee Prosthesis & Legacy Knee Prosthesis W/CO-Nidium Surface Hardening Process

- Pathway: 510(k) (Traditional)
- Applicant: Zimmer, Inc.
- Decided: Aug 23, 1996 after 78 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: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device 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) Cobalt-Chromium Molybdenum Alloy Femoral Heads with Co-Nidium Surface Hardening Process: named in the summary without a submission number
- (no number) MG II® Total Knee System with 7i-Nidium® Surface Hardening Process: named in the summary without a submission number
- (no number) MG II® Porous Total Knee System: named in the summary without a submission number
- (no number) NexGen® Complete Knee Solution: named in the summary without a submission number
- (no number) Legacy™ Knee System: named in the summary without a submission number

## Recalls of this device
- Jan 11, 2016 · Class II · Z-0833-2016: LDPE bag containing the implant adheres to the highly polished implant surface.

## Indications for use
Knee femoral components are single use devices implanted in the human knee during total knee arthroplasty. This knee is intended for cement use only.

Source page: https://510kreport.com/device/K962196
Methodology: https://510kreport.com/methodology