# K061681: Repicci II Metal Back Inlay Unicompartmental Tibial Bearing Component

- Pathway: 510(k) (Traditional)
- Applicant: Biomet Manufacturing Corp
- Decided: Oct 19, 2006 after 126 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). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 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.

## 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. The devices covered in this 510(k) are intended to be used with Repicci Femoral component. The device is intended to be used with bone cement.

Source page: https://510kreport.com/device/K061681
Methodology: https://510kreport.com/methodology