# K050764: Uniglide Unicondylar Knee Prosthesis

- Pathway: 510(k) (Traditional)
- Applicant: Corin USA
- Decided: Aug 24, 2005 after 153 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: 3 generations back to K971938 (1997). 7 ancestors in all.
2 later devices descend from it; 1 cites 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)
- K042093: Vanguard M Series Unicondylar Tibial Bearings, Biomet, Inc. (2004) Summary page 2.
- K980665: Repicci II Unicondylar Knee All Poly Tibial Components, Biomet, Inc. (1998) Summary page 2.
- K954186: Sled Unicompartment Knee System, Link America, Inc. (1996) Summary page 2.
- K982859: UC-Plus Solution Unicondylar Knee System, Plus Orthopedics (1999) Summary page 2.

## Most influential descendants
- K170344: Tahoe Uni Knee System (2017), 1 descendant of its own
- K260796: Tahoe Unicondylar Knee System with TiNbN Overcoat (2026), 0 descendants of its own

## Indications for use
The Uniglide unicondylar knee replacement system is indicated for use in the replacement of the articulating surfaces of one tibio-femoral compartment of the knee where this has been affected by primary degenerative disease, post traumatic degenerative disease or damage due to previous surgical intervention. The device is indicated in these cases where the degeneration is substantially limited to the compartment to be replaced and the anterior and posterior cruciate ligaments are present and functionally intact. The device is indicated for use in the medial or lateral compartment of the knee. The device is intended to be used with bone cement. The device is intended for prescription use only.

Source page: https://510kreport.com/device/K050764
Methodology: https://510kreport.com/methodology