# K021621: Fixed Bearing Uni Component

- Pathway: 510(k) (Special)
- Applicant: Biomet, Inc.
- Decided: Jun 5, 2002 after 20 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: 1 generation back to K971938 (1997). 1 ancestor in all.
7 later devices descend from it; 2 cite 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)
- K971938: Repicci II Unicondylar Knee, Biomet, Inc. (1997) Summary page 1.

## Most influential descendants
- K042093: Vanguard M Series Unicondylar Tibial Bearings (2004), 6 descendants of its own
- 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

## Indications for use
The Fixed Bearing Uni Component is indicated for use for 1) Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved; 2) Correction of varus, valgus, or posttraumatic deformity; and 3) Correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure. This device is intended to be used with bone cement.

Source page: https://510kreport.com/device/K021621
Methodology: https://510kreport.com/methodology