# K222380: TriVerse Total Knee Replacement System

- Pathway: 510(k) (Traditional)
- Applicant: Signature Orthopaedics Pty, Ltd.
- Decided: Oct 4, 2022 after 60 days
- Product code: JWH (Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer)
- Device class: 2
- Regulation: 21 CFR 888.3560
- 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 K810258 (1981). 41 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 43 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K113550: Vanguard Complete Knee System, Biomet Manufacturing Corp (2012) Summary page 4.

## Most influential descendants
- K253239: Active-V Total Knee System; World Total Knee System (2025), 0 descendants of its own

## Indications for use
The patient should be skeletally mature to receive a knee replacement. Patients should have adequate bone stock and size to support and accept the prosthesis. The patient's need for knee replacement should be due to one or more of the following conditions: - Non-inflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis. - Inflammatory degenerative joint disease including rheumatoid arthritis. - Functional deformity such as varus, valgus or flexion deformities. - Revision procedures where other treatments or devices have failed. Signature Orthopaedics' TriVerse Total Knee Replacement System components are indicated for cemented application only.

Source page: https://510kreport.com/device/K222380
Methodology: https://510kreport.com/methodology