# K011138: Oxford Unicompartmental Knee Femoral Component

- Pathway: 510(k) (Traditional)
- Applicant: Biomet, Inc.
- Decided: Jul 10, 2001 after 88 days
- Product code: HRY (Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer)
- Device class: 2
- Regulation: 21 CFR 888.3530
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K873601 (1988). 2 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 6 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.
- K873601: Agc Unicompartmental Knee Prosthesis, Biomet, Inc. (1988) Summary page 1.

## Most influential descendants
- K122277: Oxford Fixed Lateral Bearing Partial Knee Replacement (Oxford Tibial Trays a-F) Ixford Partial Knee Replacement System (2012), 2 descendants of its own
- K133940: Oxford Fixed Lateral Bearing Partial Knee Replacement (Bearings / Trays) (2014), 1 descendant of its own
- K251618: MOTO Partial Knee System Extension (2025), 0 descendants of its own

## Recalls of this device
- Apr 22, 2011 · Not classified · Z-2698-2011: This recall was initiated due to a customer complaint which reported that while peeling off the Tyvek lid on the blister pack, very little effort was required to remove it and this could lead to conta

## 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, deformity or revision of previous arthroplasty. The device is a single use, cemented implant

Source page: https://510kreport.com/device/K011138
Methodology: https://510kreport.com/methodology