# K994214: Gem Knee System

- Pathway: 510(k) (Traditional)
- Applicant: Kinamed, Inc.
- Decided: Jul 19, 2000 after 218 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.
121 later devices descend from it; 5 cite it directly.
0 of 122 devices 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.

## Most influential descendants
- K021313: Search Evolution Total Knee System (2002), 120 descendants of its own
- K022672: Columbus Total Knee System (CR) (2002), 96 descendants of its own
- K032108: Search Evolution (LC) Total Knee System (Porous Coated) (2004), 80 descendants of its own
- K070981: Search Evolution (LC) Total Knee System (Plasmapore) (2007), 79 descendants of its own
- K081023: Evolis Total Knee System (2008), 78 descendants of its own

## Indications for use
The Kinamed Inc. Gem Knee System is indicated for use in reconstruction of the diseased knee joint caused by osteoarthritis, rheumatoid arthritis, post-traumatic arthritis, the need to revise failed arthroplasties or osteotomies where pain, deformity or dysfunction persist, and for patients suffering from correctable valgus or varus deformity and moderate flexion contracture. The Gem Knee System is designed for use with bone cement.

Source page: https://510kreport.com/device/K994214
Methodology: https://510kreport.com/methodology