# K063515: Titanium Repicci II Unicondylar Femoral Knee Components Cocr Repicci II Unicondylar Knee

- Pathway: 510(k) (Traditional)
- Applicant: Biomet Manufacturing, Inc.
- Decided: Feb 2, 2007 after 73 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 K971938 (1997). 4 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041466: Titanium Femoral Knee Components (Maxim and Agc), Biomet Manufacturing Corp (2004) Summary page 1.
- K020264: Repicci II Unicondylar Knee System, Biomet Orthopedics, Inc. (2002) Summary page 1.
- K981996: Titanium Femoral Component, Biomet, Inc. (1999) Summary page 1.
- K971938: Repicci II Unicondylar Knee, Biomet, Inc. (1997) Summary page 1.

## Most influential descendants
- K203341: ACS LD Uni FB Knee System (2021), 1 descendant of its own
- K260037: implantcast Packaging System Update (2026), 0 descendants of its own

## Indications for use
The Titanium Repicci II® Unicondylar Femoral Knee Components and CoCr Repicci II® Unicondylar Knee are indicated for 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. These devices are single-use implants intended for implantation with bone cement.

Source page: https://510kreport.com/device/K063515
Methodology: https://510kreport.com/methodology