# K112906: Klassic Knee System

- Pathway: 510(k) (Traditional)
- Applicant: Total Joint Orthopedics, Inc.
- Decided: Feb 1, 2012 after 121 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: 3 generations back to K923277 (1993). 21 ancestors in all.
33 later devices descend from it; 12 cite it directly.
0 of 55 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K994370: Ortho Development Balanced Knee System, Ortho Development Corp. (2000)
- K090705: Balanced Knee System Ultracongruent Tibial Insert, Ortho Development Corp. (2009) Summary page 2.
- K936159: Natural-Knee II System, Intermedics Orthopedics (1995) Summary page 2.
- K060192: Apex Knee System, Omni Life Science, Inc. (2006). Our reading of the summary gave K960192, FDA’s number for Positron Coincidence Detection (Philips Medical Systems (Cleveland), Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “OMNI Life Science, Inc., Apex Knee System”.
- K925242: Apollo (TM) Knee System, Intermedics Orthopedics (1993) Summary page 2.
- K935523: Natural-Knee (R)/Apollo (TM) Knee, Intermedics Orthopedics (1995) Summary page 2.
- K910500: Howmedica Kinemax Plus Total Knee System, Howmedica Corp. (1991) Summary page 2.

## Most influential descendants
- K140942: Klassic Knee Tibial Stem Extension (2014), 27 descendants of its own
- K153310: Klassic Knee System (2015), 24 descendants of its own
- K153075: Klassic Knee System (2015), 24 descendants of its own
- K150105: Klassic Knee System-Sombrero Patella (2015), 24 descendants of its own
- K162422: Klassic Knee System (2016), 23 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/K112906
Methodology: https://510kreport.com/methodology