# K073602: Modification to: Apex Knee System

- Pathway: 510(k) (Special)
- Applicant: Omnlife Science
- Decided: Feb 14, 2008 after 55 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: 2 generations back to K943462 (1994). 7 ancestors in all.
72 later devices descend from it; 3 cite it directly.
0 of 80 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060192: Apex Knee System, Omni Life Science, Inc. (2006) Summary page 2.
- K062654: Depuy Sigma Cruciate Retaining Porocoat Femoral Components, DePuy Orthopaedics, Inc. (2006) Summary page 2.

## Most influential descendants
- K080842: Apex Knee System, Model KC-230XY, KC-240XY [ NO Holes, 2 Holes] (2008), 61 descendants of its own
- K131353: Comprehensive Reverse Shoulder - Titanium Glenosphere (2013), 60 descendants of its own
- K140478: Aequalis Reversed Shoulder Prosthesis (2014), 21 descendants of its own
- K193373: Comprehensive® Reverse Shoulder (2020), 20 descendants of its own
- K172502: Comprehensive Augmented Glenoid Components, Comprehensive Standard Baseplate, Comprehensive Mini Baseplate (2018), 20 descendants of its own

## Indications for use
The Apex Knee System is intended, for use as a primary or revision total knee replacement. This knee replacement system is intended for cemented fixation, with the option of using a porous coated femoral comronent for uncemented or cemented fixation. This prosthesis may be used for the following conditions, as appropriate: * Non-inflammatory degenerative joint disease, including osteoarthritis and avascular necrosis; * Rheumatoid arthritis; * Correction of functional deformity; • Congenital dislocation; * Revision procedures where other treatments or devices have failed.

Source page: https://510kreport.com/device/K073602
Methodology: https://510kreport.com/methodology