# K243991: Klassic Knee System - Revision Tibial Baseplate

- Pathway: 510(k) (Traditional)
- Applicant: Total Joint Othopedics, Inc.
- Decided: Mar 24, 2025 after 88 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: 6 generations back to K870730 (1987). 41 ancestors in all.
1 later device descends 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 6.
- K230537: Klassic Knee Revision System, Total Joint Othopedics, Inc. (2023) Summary page 6.

## Most influential descendants
- K261734: Klassic Infection Spacer System (2026), 0 descendants of its own

## 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 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/K243991
Methodology: https://510kreport.com/methodology