# K260796: Tahoe Unicondylar Knee System with TiNbN Overcoat

- Pathway: 510(k) (Special)
- Applicant: Shalby Advanced Technologies, Inc. Dba Consensus Orthopedics
- Decided: Apr 2, 2026 after 22 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: 7 generations back to K971938 (1997). 66 ancestors in all.
No later device cites it as a predicate yet.
0 of 67 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170344: Tahoe Uni Knee System, Consensus Orthopedics, Inc. (2017) Summary page 5.
- K241180: Consensus Knee System with TiNbN, Shalby Advanced Technologies (2025) Summary page 5.
- K122239: Foundation Knee System with Tinbn Coating Foundation PS Knee System with Tinbn Coating 3DKNEE System with Tinbn Coating, Encore Medical L.P. (2013) Summary page 5.
- K182251: EVOLUTION NitrX Medial-Pivot Knee, Mircoport Orthopedics, Inc. (2019) Summary page 5.

## Indications for use
The Tahoe Unicondylar 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 (TiNbN coated and uncoated) are single use only and are intended for implantation only with bone cement.

Source page: https://510kreport.com/device/K260796
Methodology: https://510kreport.com/methodology