# K230537: Klassic Knee Revision System

- Pathway: 510(k) (Traditional)
- Applicant: Total Joint Othopedics, Inc.
- Decided: May 19, 2023 after 81 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: 5 generations back to K870730 (1987). 40 ancestors in all.
2 later devices descend 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)
- K112906: Klassic Knee System, Total Joint Orthopedics, Inc. (2012) Summary page 5.
- K140942: Klassic Knee Tibial Stem Extension, Total Joint Orthopedics, Inc. (2014) Summary page 5.
- K070095: Triathlon TS Knee System, Howmedica Osteonics Corp. (2007) Summary page 5.

## Most influential descendants
- K243991: Klassic Knee System - Revision Tibial Baseplate (2025), 1 descendant of its own
- K261734: Klassic Infection Spacer System (2026), 0 descendants of its own

## Indications for use
The Klassic® Revision 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 (1JD): 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® Revision System is indicated for cemented use only, except for the Klassic® Femur, with Cobalt 3D®, 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/K230537
Methodology: https://510kreport.com/methodology