# K140942: Klassic Knee Tibial Stem Extension

- Pathway: 510(k) (Traditional)
- Applicant: Total Joint Orthopedics, Inc.
- Decided: May 16, 2014 after 32 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: 4 generations back to K870730 (1987). 39 ancestors in all.
27 later devices descend from it; 4 cite it directly.
0 of 67 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 2.
- K063633: Depuy Knee Prosthesis System Universal Stem Extensions and Femoral Metaphyseal Sleeves, DePuy Orthopaedics, Inc. (2007) Summary page 2.
- K070095: Triathlon TS Knee System, Howmedica Osteonics Corp. (2007) Summary page 2.

## Most influential descendants
- K162422: Klassic Knee System (2016), 23 descendants of its own
- K180159: Klassic® Knee System (2018), 22 descendants of its own
- K190562: iTotal Identity Cruciate Retaining Knee Replacement System (2019), 15 descendants of its own
- K201023: iTotal® Identity Posterior Stabilized Knee Replacement System (2020), 14 descendants of its own
- K203447: iTotal Identity Cruciate Retaining (CR) Total Knee Replacement, iTotal Identity Posterior Stabilizing (PS) Total Knee Replacement (2020), 12 descendants of its own

## Indications for use
The Klassic Knee Tibial Stem Extension is intended for use with the Klassic Knee System. The Klassic Knee System is intended for prosthetic replacement with the use of bone cement 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

Source page: https://510kreport.com/device/K140942
Methodology: https://510kreport.com/methodology