# K973672: Foundation Plasma Sprayed Metal-Backed Patella

- Pathway: 510(k) (Traditional)
- Applicant: Encore Orthopedics, Inc.
- Decided: Dec 18, 1997 after 83 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
Longest line of descent: 1 generation back to K863805 (1986). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K932246: Foundation Metal-Backed Patella, Encore Orthopedics, Inc. (1994) Summary page 1.
- K863805: Miller/Galante Total Knee Por Coated Patellar Dome, Zimmer, Inc. (1986) Summary page 1.
- K873601: Agc Unicompartmental Knee Prosthesis, Biomet, Inc. (1988) Summary page 1.

## Indications for use
The Foundation® Plasma Sprayed Metal-backed Patella is intended to be used us a cemented patellar surface replacement in treating patients who are candidates for primary total knee arthroplsty as a result of osteoarthritis, inflammatory arthritis, traumatic arthritis or rheumatoid arthritis with or without varus, valgus, or flexion deformities. or revision arthroplasty where bone loss is minimal. It is intended to aid the surgeon in relieving the patient of knee pain and restoring knee joint function.

Source page: https://510kreport.com/device/K973672
Methodology: https://510kreport.com/methodology