# K100197: Genesis Unicondylar Uhmwpe Articular Inserts

- Pathway: 510(k) (Special)
- Applicant: Smith & Nephew, Inc.
- Decided: Feb 19, 2010 after 28 days
- Product code: HSX (Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer)
- Device class: 2
- Regulation: 21 CFR 888.3520
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K912735 (1991). 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)
- K912735: Genesis Unicompartmental Knee System, Smith & Nephew Richards, Inc. (1991) Summary page 1.
- K061011: Competitor Unicondylar Knee Tibial Baseplate, Smith & Nephew, Inc. (2006) Summary page 1.

## Indications for use
The Genesis Unicondylar UHMWPe Articular Inserts are indicated for restoring either compartment of a knee that has been affected by the following: * Non-inflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis; * Correction of functional deformity; * Revision procedures where other treatments or devices have failed; and * Treatment of fractures that are unmanageable using other techniques. The implants are single use only and are designed to be used in combination with Genesis Unicondylar baseplates that are intended for implantation with bone cement.

Source page: https://510kreport.com/device/K100197
Methodology: https://510kreport.com/methodology