# K060192: Apex Knee System

- Pathway: 510(k) (Traditional)
- Applicant: Omni Life Science, Inc.
- Decided: Jun 15, 2006 after 141 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: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K943462 (1994). 4 ancestors in all.
111 later devices descend from it; 9 cite it directly.
0 of 116 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K943462: Darwin Knee System, Johnson & Johnson Professionals, Inc. (1994) Summary page 2.
- K961685: P.F.C. Cruciate Retaining Knee System (Size 1.5), Johnson & Johnson Professionals, Inc. (1996) Summary page 2.
- K973412: Natural-Knee II Constrained Knee System, Sulzer Orthopedics, Inc. (1997) Summary page 2.
- K021578: Natural-Knee II System Cocr Tibial Baseplate, Sulzer Orthopedics, Inc. (2002) Summary page 2.

## Most influential descendants
- K073602: Modification to: Apex Knee System (2008), 72 descendants of its own
- 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
- K112906: Klassic Knee System (2012), 33 descendants of its own
- K140942: Klassic Knee Tibial Stem Extension (2014), 27 descendants of its own

## Recalls of this device
- Nov 20, 2017 · Class II · Z-1117-2018: The Apex Knee System Tibial Baseplate identified has an improper expiration date marked on the external packaging. The improper expiration date (2202-03) is marked on the external packaging only. The 

## 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 and single use implantation. This prosthesis may be used for the following conditions, as appropriate: * Non-inflammatory degenerative joint disease, including osteoarthritis and avascular necrosis; * Rheurmatoid arthritis; * Correction of functional deformity; * Revision procedures where other treatments or devices have failed.

Source page: https://510kreport.com/device/K060192
Methodology: https://510kreport.com/methodology