# K242746: OvertureTi Knee Resurfacing SystemTM

- Pathway: 510(k) (Special)
- Applicant: Overture Orthopaedics
- Decided: Oct 7, 2024 after 26 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: 4 generations back to K923011 (1993). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K221292: Uni Knee Resurfacing System, Overture Resurfacing, Inc. (2023) Summary page 6.

## Indications for use
The OvertureTi 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/K242746
Methodology: https://510kreport.com/methodology