# K221292: Uni Knee Resurfacing System

- Pathway: 510(k) (Traditional)
- Applicant: Overture Resurfacing, Inc.
- Decided: Mar 10, 2023 after 310 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: 3 generations back to K923011 (1993). 9 ancestors in all.
1 later device descends 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)
- K050373: Unicap Unicompartmental Knee Resurfacing Prosthesis, Arthrosurface, Inc. (2005) Summary page 4.

## Most influential descendants
- K242746: OvertureTi Knee Resurfacing SystemTM (2024), 0 descendants of its own

## Indications for use
The Overture Resurfacing Uni Knee Resurfacing System is intended to be used in the partial replacement of the articulating surfaces of the knee in instances where, due to compartmental degenerative disease, post-traumatic degenerative disease, previous tibial condyle or plateau fractures, deformity, or previous arthroplasty, only the one side of the joint is affected. This device is intended to be used with bone cement.

Source page: https://510kreport.com/device/K221292
Methodology: https://510kreport.com/methodology