# K030446: Repicci Locked Keel Tibial Bearing

- Pathway: 510(k) (Special)
- Applicant: Biomet, Inc.
- Decided: Mar 6, 2003 after 23 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: 2 generations back to K980665 (1998). 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)
- K011795: Worland Unicondylar Tibial Bearing, Biomet, Inc. (2001)

## Indications for use
Partial replacement of 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 Components. The device is a single use implant intended for implantation with bone cement.

Source page: https://510kreport.com/device/K030446
Methodology: https://510kreport.com/methodology