# K232414: Klassic® Tibial Insert, PS-Post, Klassic All Poly Tibia, PS-Post

- Pathway: 510(k) (Special)
- Applicant: Total Joint Othopedics, Inc.
- Decided: Sep 8, 2023 after 29 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: 8 generations back to K870730 (1987). 47 ancestors in all.
No later device cites it as a predicate yet.
0 of 48 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112906: Klassic Knee System, Total Joint Orthopedics, Inc. (2012) Summary page 5.
- K162422: Klassic Knee System, Total Joint Orthopedics, Inc. (2016) Summary page 5.
- K183596: Klassic Knee System - Klassic Knee PS-Post Femur; Klassic Knee Tibial Insert, PS-Post, Std Poly; Klassic Knee Tibial Insert, PS-Post, E-Link Poly, Total Joint Orthopedics, Inc. (2019) Summary page 5.

## Indications for use
The Klassic® Knee System is intended for prosthetic replacement in treatment of the following: • Patient conditions of non-inflammatory degenerative joint disease (NIDJD): avascular necrosis and osteoarthritis • Patient conditions of inflammatory joint disease (IJD): rheumatoid arthritis • Patients with failed previous surgery where pain, deformity, or dysfunction persists • Correctable varus-valgus deformity and moderate flexion contracture • Revision of a previously failed knee arthroplasty • Patients who require a total knee replacement The Klassic® Knee System is indicated for cemented use only, except for the Klassic® Femur, with Cobalt 30®, the Klassic® Tibial Baseplate with Ti-Coat® and the Universal Cones ™ with Ti-Coat®, which are also indicated for cementless use.

Source page: https://510kreport.com/device/K232414
Methodology: https://510kreport.com/methodology