# K101206: TGS Unicompartmental Knee Arthroplasty (TGS Uka) Modular Tibia System

- Pathway: 510(k) (Traditional)
- Applicant: Alexandria Research Technologies, LLC
- Decided: Jul 23, 2010 after 84 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: 2 generations back to K954481 (1996). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040268: Depuy Preservation Unicondylar Tibia, DePuy Orthopaedics, Inc. (2004) Summary page 1.
- K912735: Genesis Unicompartmental Knee System, Smith & Nephew Richards, Inc. (1991) Summary page 1.
- K090024: TGS Unicompartmental Knee Arthroplasty System, Alexandria Research Technologies, LLC (2009) Summary page 1.

## Indications for use
The TGS® Unicompartmental Knee Arthroplasty System is intended for arthroplasty of either condyle of a knee with the following indications: 1. Non-inflammatory degenerative joint disease including post-traumatic arthritis and osteoarthritis. 2. Failed previous implant. 3. Correctable deformity. 4. All TGSO UKA System implants are intended for cemented use only. 5. Components of this system are designed for single use and to be used as a system.

Source page: https://510kreport.com/device/K101206
Methodology: https://510kreport.com/methodology