# K050373: Unicap Unicompartmental Knee Resurfacing Prosthesis

- Pathway: 510(k) (Traditional)
- Applicant: Arthrosurface, Inc.
- Decided: Oct 11, 2005 after 239 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 K923011 (1993). 8 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K880155: Miller/Galante Precoat Unicompartmental Knee, Zimmer, Inc. (1988) Summary page 2.
- K954186: Sled Unicompartment Knee System, Link America, Inc. (1996) Summary page 2.
- K033769: Eius Unicompartmental Knee System, Howmedica Osteonics Corp. (2004) Summary page 2.
- K032824: Stelkast Unicondylar Knee System, Stelkast Company (2003) Summary page 2.

## Most influential descendants
- K221292: Uni Knee Resurfacing System (2023), 1 descendant of its own
- K242746: OvertureTi Knee Resurfacing SystemTM (2024), 0 descendants of its own

## Indications for use
The Unicompartmental Knee Resurfacing Prosthesis (UniCAP TM) is indicated for use as a partial replacement of the articulating surfaces of the knee when only one side of the joint is affected due to the compartmental primary degenerative or post-traumatic degenerative disease, previous tibial condyle or plateau fractures, deformity or revision of previous arthroplasty. This device is intended to be used with bone cement.

Source page: https://510kreport.com/device/K050373
Methodology: https://510kreport.com/methodology