# K231253: Overture Orthopaedics Patellofemoral System

- Pathway: 510(k) (Traditional)
- Applicant: Overture Resurfacing, Inc.
- Decided: Jul 7, 2023 after 67 days
- Product code: KRR (Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer)
- Device class: 2
- Regulation: 21 CFR 888.3540
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K060127 (2006). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060127: Hemicap Patello-Femoral Resurfacing Prosthesis, Arthrosurface, Inc. (2006) Summary page 4.

## Indications for use
The Overture Orthopaedics Patellofemoral System is intended to be used in cemented arthroplasty in patients with osteoarthritis limited to the distal patello-femoral joint, patients with a history of patellar dislocation or patellar fracture, and those patients with failed previous surgery (arthroscopy, tibial tubercle elevation, lateral release, etc.) where pain, deformity or dysfunction persists.

Source page: https://510kreport.com/device/K231253
Methodology: https://510kreport.com/methodology