# K963148: Nexgen Complete Knee Solution

- Pathway: 510(k) (Traditional)
- Applicant: Zimmer, Inc.
- Decided: Feb 13, 1997 after 184 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.
87 later devices descend from it; 4 cite it directly.
0 of 88 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) NexGen® Complete Knee Solution: named in the summary without a submission number
- (no number) Insall/Burstein® Total Knee System: named in the summary without a submission number

## Most influential descendants
- K081023: Evolis Total Knee System (2008), 78 descendants of its own
- K090988: GMK Total Knee System (2009), 52 descendants of its own
- K102437: GMK Revision Knee System (2010), 34 descendants of its own
- K103170: GMK Revision Knee SC Liners (2011), 28 descendants of its own
- K113571: GMK Resufacing Patella Size 4 (2012), 23 descendants of its own

## Recalls of this device
- Oct 12, 2006 · Not classified · Z-0209-2007: The polyethylene tibial articular surface may not lock into some of the tibial plates.

## 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/K963148
Methodology: https://510kreport.com/methodology