# K022010: Total Knee Femoral Component

- Pathway: 510(k) (Special)
- Applicant: Smith & Nephew, Inc.
- Decided: Aug 19, 2002 after 61 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.
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) Genesis II Total Knee System components: named in the summary without a submission number
- (no number) Profix Total Knee System components: named in the summary without a submission number

## Indications for use
The Total Knee Femoral Components are indicated for rheumatoid arthritis; post-traumatic athitis; degenerative arthritis; and failed osteotomies, hemiarthroplasties; or total knee arthroplasties. The Total Knee Femoral Components are single use only and are intended for implantation with bone cement.

Source page: https://510kreport.com/device/K022010
Methodology: https://510kreport.com/methodology