# K133940: Oxford Fixed Lateral Bearing Partial Knee Replacement (Bearings / Trays)

- Pathway: 510(k) (Traditional)
- Applicant: Biomet UK, Ltd.
- Decided: Mar 28, 2014 after 95 days
- Product code: HRY (Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer)
- Device class: 2
- Regulation: 21 CFR 888.3530
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K971938 (1997). 7 ancestors in all.
1 later device descends 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)
- K122277: Oxford Fixed Lateral Bearing Partial Knee Replacement (Oxford Tibial Trays a-F) Ixford Partial Knee Replacement System, Biomet Manufacturing Corp (2012) Summary page 1.

## Most influential descendants
- K251618: MOTO Partial Knee System Extension (2025), 0 descendants of its own

## Recalls of this device
- Dec 15, 2022 · Class II · Z-1018-2023: Packaged in the incorrect shelf carton. Incorrect shelf carton; outer carton is smaller than the required outer carton, which forces the Tyvex pouch to be folded and packaged in the carton causing com
- Nov 25, 2020 · Class II · Z-0624-2021: Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to loss of sterility of the device.
- Apr 17, 2020 · Class II · Z-2148-2020: Potential presence of elevated endotoxin levels that exceed the specification limit
- Dec 6, 2016 · Class II · Z-0956-2017: Zimmer Biomet is initiating a removal of a single lot of Oxford Fixed Lateral Bearings due to mislabeling. Zimmer Biomet received product complaints reporting that when the package labeled as a Right 

## 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/K133940
Methodology: https://510kreport.com/methodology