# K122277: Oxford Fixed Lateral Bearing Partial Knee Replacement (Oxford Tibial Trays a-F) Ixford Partial Knee Replacement System

- Pathway: 510(k) (Traditional)
- Applicant: Biomet Manufacturing Corp
- Decided: Oct 22, 2012 after 84 days
- Product code: HRY (Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer)
- Device class: 2
- Regulation: 21 CFR 888.3530
- Recalls of this device: 30 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K971938 (1997). 6 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042093: Vanguard M Series Unicondylar Tibial Bearings, Biomet, Inc. (2004) Summary page 1.
- K011138: Oxford Unicompartmental Knee Femoral Component, Biomet, Inc. (2001) Summary page 1.

## Most influential descendants
- 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
- Jun 7, 2013 · Class II · Z-1712-2013: Biomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in terminal extension.
- Jun 7, 2013 · Class II · Z-1701-2013: Biomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in terminal extension.
- Jun 7, 2013 · Class II · Z-1703-2013: Biomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in terminal extension.
- Jun 7, 2013 · Class II · Z-1697-2013: Biomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in terminal extension.
- Jun 7, 2013 · Class II · Z-1717-2013: Biomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in terminal extension.
- Jun 7, 2013 · Class II · Z-1720-2013: Biomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in terminal extension.
- Jun 7, 2013 · Class II · Z-1711-2013: Biomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in terminal extension.
- Jun 7, 2013 · Class II · Z-1709-2013: Biomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in terminal extension.
- Jun 7, 2013 · Class II · Z-1716-2013: Biomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in terminal extension.
- Jun 7, 2013 · Class II · Z-1696-2013: Biomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in terminal extension.
- Jun 7, 2013 · Class II · Z-1706-2013: Biomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in terminal extension.
- Jun 7, 2013 · Class II · Z-1708-2013: Biomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in terminal extension.
- Jun 7, 2013 · Class II · Z-1724-2013: Biomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in terminal extension.
- Jun 7, 2013 · Class II · Z-1713-2013: Biomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in terminal extension.
- Jun 7, 2013 · Class II · Z-1704-2013: Biomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in terminal extension.
- Jun 7, 2013 · Class II · Z-1718-2013: Biomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in terminal extension.
- Jun 7, 2013 · Class II · Z-1698-2013: Biomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in terminal extension.
- Jun 7, 2013 · Class II · Z-1715-2013: Biomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in terminal extension.
- Jun 7, 2013 · Class II · Z-1702-2013: Biomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in terminal extension.
- Jun 7, 2013 · Class II · Z-1710-2013: Biomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in terminal extension.
- Jun 7, 2013 · Class II · Z-1700-2013: Biomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in terminal extension.
- Jun 7, 2013 · Class II · Z-1695-2013: Biomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in terminal extension.
- Jun 7, 2013 · Class II · Z-1722-2013: Biomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in terminal extension.
- Jun 7, 2013 · Class II · Z-1723-2013: Biomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in terminal extension.
- Jun 7, 2013 · Class II · Z-1707-2013: Biomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in terminal extension.
- Jun 7, 2013 · Class II · Z-1719-2013: Biomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in terminal extension.
- Jun 7, 2013 · Class II · Z-1705-2013: Biomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in terminal extension.
- Jun 7, 2013 · Class II · Z-1714-2013: Biomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in terminal extension.
- Jun 7, 2013 · Class II · Z-1699-2013: Biomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in terminal extension.
- Jun 7, 2013 · Class II · Z-1721-2013: Biomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in terminal extension.

## Indications for use
Partial replacement of the articulating surfaces of the knee when only one side of the knee joint is affected due to the compartmental primary degenerative or post-traumatic degenerative disease, previous tibial condyle or plateau fractures, deformity or revision of previous partial arthroplasty in the affected compartment. The Oxford Fixed Lateral bearings are indicated for use in the lateral compartment and intended to be implanted with bone cement. The Oxford Femoral components are indicated for use in the lateral compartment for a fixed. bearing application. They are intended to be implanted with bone cement.

Source page: https://510kreport.com/device/K122277
Methodology: https://510kreport.com/methodology