# K032950: Gem Inset Patellar Component

- Pathway: 510(k) (Traditional)
- Applicant: Kinamed, Inc.
- Decided: Dec 19, 2003 after 88 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The Gem Inset Patellar Component is intended to articulate with the Gem Total Knee femoral component or the KineMatch Patello-Femoral Resurfacing Implant. The Gem Inset Patellar Component is a single use device that is intended for cemented applications on the surgically prepared posterior patella as part of primary or revision knee arthroplasty. The Gem Inset Patellar Component replaces the patellar articulating surface of the knee joint to simulate the normal function of the knee.

Source page: https://510kreport.com/device/K032950
Methodology: https://510kreport.com/methodology