# K190280: Klassic Knee System - Sombrero Patella with Standard Poly, Klassic Knee System - Sombrero Patella with E-Link Poly

- Pathway: 510(k) (Special)
- Applicant: Total Joint Orthopedics, Inc.
- Decided: Mar 15, 2019 after 35 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: 7 generations back to K870730 (1987). 46 ancestors in all.
No later device cites it as a predicate yet.
0 of 47 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150105: Klassic Knee System-Sombrero Patella, Total Joint Orthopedics, Inc. (2015) Summary page 5.
- K180159: Klassic® Knee System, Total Joint Orthopedics, Inc. (2018) 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 (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 Knee System is indicated for cemented use only, except for the Klassic Femur with Cobalt 3D™, and the Klassic Tibial Baseplate with Ti-Coat®, which are indicated for cementless use.

Source page: https://510kreport.com/device/K190280
Methodology: https://510kreport.com/methodology