# K170344: Tahoe Uni Knee System

- Pathway: 510(k) (Traditional)
- Applicant: Consensus Orthopedics, Inc.
- Decided: Oct 5, 2017 after 244 days
- Product code: HSX (Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer)
- Device class: 2
- Regulation: 21 CFR 888.3520
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K971938 (1997). 25 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050764: Uniglide Unicondylar Knee Prosthesis, Corin USA (2005) Summary page 5.
- K971938: Repicci II Unicondylar Knee, Biomet, Inc. (1997) Summary page 5.
- K021621: Fixed Bearing Uni Component, Biomet, Inc. (2002) Summary page 5.
- K042093: Vanguard M Series Unicondylar Tibial Bearings, Biomet, Inc. (2004) Summary page 5.
- K022437: Uni Knee, Encore Medical L.P. (2002) Summary page 5.
- K020741: Unicondylar Knee, Encore Orthopedics, Inc. (2002) Summary page 5.
- K123380: Stride Unicondylar Knee, Blue Belt Technologies, Inc. (2013) Summary page 5.

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

## Indications for use
The Tahoe Uni Knee System (TUKS) is designed as a system and is not intended for substitution of components from other systems. The indications for use are as follows: Primary medial or lateral compartmental intervention of (1) primary non-inflammatory degenerative disease, including osteoarthritis, traumatic arthritis, or osteonecrosis; (2) post-traumatic degenerative disease; (3) varus or valgus deformities; and (4) damage due to previous surgical intervention when the opposite compartment is preserved and when the anterior cruciate, posterior cruciate, medial, collateral, and lateral collateral ligaments are present and functional. All TUKS implants are single use only, and are intended for implantation only with bone cement.

Source page: https://510kreport.com/device/K170344
Methodology: https://510kreport.com/methodology