# K201611: Apex Knee System

- Pathway: 510(k) (Traditional)
- Applicant: Omnilife Science
- Decided: Apr 2, 2021 after 291 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: 10 generations back to K982302 (1998). 148 ancestors in all.
No later device cites it as a predicate yet.
0 of 149 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K191765: OMNI TiN Coated Apex Knee™ System, Omni Life Science, Inc. (2019) Summary page 4.
- K060192: Apex Knee System, Omni Life Science, Inc. (2006) Summary page 6.
- K102578: Apex PS Knee System, Omni Life Science, Inc. (2011) Summary page 6.
- K111184: Apex PS Knee System - PS-C Insert, Omni Life Science, Inc. (2011) Summary page 6.
- K112891: Apex Revision Knee Systems, Omni Life Science, Inc. (2012) Summary page 6.

## 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). The porous coated tibial baseplate is to be used uncemented (biological fixation). All other femoral, tibial baseplate, and patellar components are indicated for cemented use only. The Apex Knee™ Modular Tibia System Tibial Augments are intended to be bolted to the Tibia baseplate and cemented to the prepared tibia.

Source page: https://510kreport.com/device/K201611
Methodology: https://510kreport.com/methodology