# K231975: PNK Total Knee System

- Pathway: 510(k) (Traditional)
- Applicant: Tjc Life Co., Ltd.
- Decided: Nov 21, 2023 after 141 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 K870730 (1987). 31 ancestors in all.
No later device cites it as a predicate yet.
0 of 32 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170753: Acculoc Total Knee System, Rootloc Co., Ltd. (2018) Summary page 7.
- K110404: Eaum Total Knee System, Corentec Co., Ltd. (2012) Summary page 7.
- K130673: Lospa Total Knee Replacement System, Corentec Co., Ltd. (2013) Summary page 7.
- K170534: Prolixus Total Knee System, Otis Biotech Co., Ltd. (2017) Summary page 7.
- K142649: Progressive Orthopedic Total Knee System, The Progressive Orthopaedic Company, LLC (2015) Summary page 7.

## Indications for use
The PNK Total Knee System is indicated in knee arthroplasty for reduction or relief of pain and/or improved knee function in skeletally mature patients with severe knee pain and disability due to rheumatoid arthritis, osteoarthritis, primary and secondary traumatic arthritis, avascular necrosis of the femoral condyle, posttraumatic loss of joint configuration. Moderate valgus, varus, or flexion deformity in which the ligamentous structures can be returned to adequate function and stability. This device may also be indicated in correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous arthroplasty procedure. The PNK Total Knee System is designed for cemented use only.

Source page: https://510kreport.com/device/K231975
Methodology: https://510kreport.com/methodology