# K212870: TLC Unicompartmental Knee System

- Pathway: 510(k) (Traditional)
- Applicant: Signature Orthopaedics Pty, Ltd.
- Decided: Jun 16, 2022 after 280 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: 11 generations back to K810258 (1981). 56 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 59 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K161592: Persona Partial Knee System, Biomet, Inc. (2016) Summary page 4.

## Most influential descendants
- K261609: Freedom Partial Knee System (2026), 0 descendants of its own
- K251771: Cambridge Partial Knee (2025), 0 descendants of its own

## Indications for use
The Signature Orthopaedics' TLC Unicompartmental Knee comprising the femur component, tibial component and meniscal inserts is designed for a single compartment replacement of the natural knee joint. The TLC Unicompartmental Knee is indicated for cemented use in partial knee arthroplasty procedures. Partial replacement of the articulating surfaces of the knee is indicated only when only one compartment of the joint is affected due to the compartmental primary degenerative or post-traumatic degenerative disease, previous tibial condyle or plateau fractures, deformity or revision of previous arthroplasty.

Source page: https://510kreport.com/device/K212870
Methodology: https://510kreport.com/methodology