# K150105: Klassic Knee System-Sombrero Patella

- Pathway: 510(k) (Special)
- Applicant: Total Joint Orthopedics, Inc.
- Decided: Feb 17, 2015 after 28 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 K923277 (1993). 23 ancestors in all.
24 later devices descend from it; 4 cite it directly.
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.
- K934695: Natural-Knee Tibial Baseplate/All Poly Patella, Intermedics Orthopedics (1996) Summary page 5.

## 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 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/K150105
Methodology: https://510kreport.com/methodology