# K072704: Unicompartmental Knee

- Pathway: 510(k) (Traditional)
- Applicant: Valpo Orthopedic Technology, Inc.
- Decided: Feb 19, 2008 after 148 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). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 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.
- K033363: Zimmer Unicompartmental Knee System, Zimmer, Inc. (2004) Summary page 1.
- K010685: Modification to Miller/Galante Precoat Unicompartmental Knee System (8 MM Articular Surface), Zimmer, Inc. (2001) Summary page 1.
- K033769: Eius Unicompartmental Knee System, Howmedica Osteonics Corp. (2004) Summary page 1.
- K060412: Active Unicompartmental Knee System, Australian Surgical Design & Manufacture (2006) Summary page 1.
- K020264: Repicci II Unicondylar Knee System, Biomet Orthopedics, Inc. (2002) Summary page 1.

## Indications for use
The Unicompartmental Knee is indicated for: The Unicompartmental Knee is solely indicated for medial compartment replacement of the articulating surface 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 procedures. This device is intended for cemented use only.

Source page: https://510kreport.com/device/K072704
Methodology: https://510kreport.com/methodology