# K053299: Repicci II Onlay Unicompartmental Tibial Component

- Pathway: 510(k) (Traditional)
- Applicant: Biomet Manufacturing, Inc.
- Decided: Jan 5, 2006 after 41 days
- Product code: HRY (Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer)
- Device class: 2
- Regulation: 21 CFR 888.3530
- 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 K971938 (1997). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K971938: Repicci II Unicondylar Knee, Biomet, Inc. (1997) Summary page 1.
- K980665: Repicci II Unicondylar Knee All Poly Tibial Components, Biomet, Inc. (1998) Summary page 1.
- K010810: Depuy Preservation Unicondylar Knee Prosthesis, DePuy Orthopaedics, Inc. (2001) Summary page 1.
- K012591: Advance Unicondylar Knee System, Wrightmedicaltechnologyinc (2001) Summary page 1.

## Indications for use
Partial replacement of the articulating surfaces of the knee when only one side of the joint is affected due to compartmental primary degenerative or post-traumatic degenerative disease, previous tibial condyle or plateau fractures, deformity or revision of previous arthroplasty. This device is intended for cemented application only.

Source page: https://510kreport.com/device/K053299
Methodology: https://510kreport.com/methodology