# K232175: XN Knee Prosthesis System

- Pathway: 510(k) (Traditional)
- Applicant: Beijing Chunlizhengda Medical Instruments Co., Ltd.
- Decided: Apr 14, 2024 after 268 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: 1 generation back to K053514 (2006). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K053514: Triathlon Total Knee System, Stryker Orthopaedics (2006) Summary page 6.

## Indications for use
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. Revision of previous unsuccessful uni-knee replacement or other procedure. The system components are intended for cemented use only.

Source page: https://510kreport.com/device/K232175
Methodology: https://510kreport.com/methodology