# K230078: TRAX® CR Total Knee System

- Pathway: 510(k) (Traditional)
- Applicant: Amplitude
- Decided: Nov 3, 2023 after 297 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: 12 generations back to K810258 (1981). 119 ancestors in all.
No later device cites it as a predicate yet.
0 of 120 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K113369: Zimmer Persona Knee System, Zimmer, Inc. (2012) Summary page 5.
- K193223: Persona Personalized Knee System, Zimmer, Inc. (2020) Summary page 5.
- K161414: Anatomic Total Knee System, Amplitude (2017) Summary page 5.

## Indications for use
The TRAX® CR Total Knee System is indicated for use: - In primary total knee arthroplasty (TKA) as a result of: • Painful, disabling joint disease of the knee resulting from degenerative arthritis, rheumatoid arthritis or post-traumatic arthritis. • Post-traumatic loss of knee joint configuration and function. • Moderate varus, valgus or flexion deformity in which the ligamentous structures can be returned to adequate function and stability. - In revision of previous osteotomy, - In revision of previous unsuccessful unicompartimental or femoro-patellar knee. The TRAX® CR Total Knee System is for single use only and is intended for implantation with bone cement only.

Source page: https://510kreport.com/device/K230078
Methodology: https://510kreport.com/methodology