# K180159: Klassic® Knee System

- Pathway: 510(k) (Traditional)
- Applicant: Total Joint Orthopedics, Inc.
- Decided: Mar 9, 2018 after 49 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). 45 ancestors in all.
22 later devices descend from it; 4 cite it directly.
0 of 68 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.
- K150105: Klassic Knee System-Sombrero Patella, Total Joint Orthopedics, Inc. (2015) Summary page 5.
- K153075: Klassic Knee System, Total Joint Orthopedics, Inc. (2015) Summary page 5.
- K153310: Klassic Knee System, Total Joint Orthopedics, Inc. (2015) Summary page 5.
- K162422: Klassic Knee System, Total Joint Orthopedics, Inc. (2016) Summary page 5.

## Most influential descendants
- 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
- K210191: Identity Imprint Knee Replacement System (2021), 10 descendants of its own
- K212411: Identity Imprint Knee Replacement System (including Identity Imprint Posterior Stabilized (PS) KRS and Identity Imprint Cruciate Retaining (CR) KRS) (2021), 9 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, Porous, and the Klassic Tibial Baseplate, Porous, which are indicated for cementless use.

Source page: https://510kreport.com/device/K180159
Methodology: https://510kreport.com/methodology