# K042093: Vanguard M Series Unicondylar Tibial Bearings

- Pathway: 510(k) (Traditional)
- Applicant: Biomet, Inc.
- Decided: Nov 1, 2004 after 90 days
- Product code: HRY (Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer)
- Device class: 2
- Regulation: 21 CFR 888.3530
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K971938 (1997). 3 ancestors in all.
6 later devices descend from it; 3 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021621: Fixed Bearing Uni Component, Biomet, Inc. (2002) Summary page 1.
- K971938: Repicci II Unicondylar Knee, Biomet, Inc. (1997) Summary page 1.
- K954186: Sled Unicompartment Knee System, Link America, Inc. (1996) 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
- K050764: Uniglide Unicondylar Knee Prosthesis (2005), 2 descendants of its own
- K170344: Tahoe Uni Knee System (2017), 1 descendant of its own
- K133940: Oxford Fixed Lateral Bearing Partial Knee Replacement (Bearings / Trays) (2014), 1 descendant of its own
- K260796: Tahoe Unicondylar Knee System with TiNbN Overcoat (2026), 0 descendants of its own

## Recalls of this device
- Apr 17, 2020 · Class II · Z-2155-2020: Potential presence of elevated endotoxin levels that exceed the specification limit
- Apr 22, 2015 · Class II · Z-1798-2015: The Left and Right orientation of the trial was incorrectly etched on one side. When the instrument is rotated about the axis of the handle 180 degrees to view the other side, the etch on the handle n

## Indications for use
Partial replacement of the articulating surfaces of the knee when only one side of the 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 arthroplasty. This device is intended to be used with bone cement.

Source page: https://510kreport.com/device/K042093
Methodology: https://510kreport.com/methodology