# K102578: Apex PS Knee System

- Pathway: 510(k) (Traditional)
- Applicant: Omni Life Science, Inc.
- Decided: Mar 25, 2011 after 198 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 K943462 (1994). 10 ancestors in all.
8 later devices descend from it; 3 cite it directly.
0 of 19 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 1.
- K073602: Modification to: Apex Knee System, Omnlife Science (2008) Summary page 1.
- K950010: Darwin Knee System (Cruciate Substituting) Porous Coated and Non-Porous Coated, Johnson & Johnson Professionals, Inc. (1995) Summary page 1.
- K936159: Natural-Knee II System, Intermedics Orthopedics (1995) Summary page 1.

## Most influential descendants
- K112891: Apex Revision Knee Systems (2012), 5 descendants of its own
- K153437: Apex Revision Knee System (2015), 4 descendants of its own
- K163332: Apex Revision Knee System (2017), 3 descendants of its own
- K191765: OMNI TiN Coated Apex Knee™ System (2019), 2 descendants of its own
- K111184: Apex PS Knee System - PS-C Insert (2011), 2 descendants of its own

## Indications for use
The Apex Knee™ System is intended for use as a primary or revision total knee replacement. 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; Revision procedures where other treatments or devices have failed; The porous coated femoral component may be used cemented or uncemented (biological fixation). All other femoral, tibial baseplate and patellar components are indicated for cemented use only. The Apex Knee Modular Tibia System Tibial Augment are intended to be bolted to the Tibia baseplate and cemented to the prepared tibia.

Source page: https://510kreport.com/device/K102578
Methodology: https://510kreport.com/methodology