# K111062: Apex Knee System, Apex All Poly Tibia

- Pathway: 510(k) (Traditional)
- Applicant: Omni Life Science, Inc.
- Decided: Jul 13, 2011 after 86 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). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K002740: Tibial & Patellar Components for the Profix & Genesis II Total Knee Systems, Smith & Nephew, Inc. (2000) Summary page 1.
- K060192: Apex Knee System, Omni Life Science, Inc. (2006) Summary page 1.

## Indications for use
The Apex Knee TM System, Apex All Poly Tibia: The Apex All Poly Tibia is intended for use as part of 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 Apex All Poly Tibia is for use only with the Apex Knee System Femoral and Patella components. The Apex All Poly Tibia is indicated for cemented use only.

Source page: https://510kreport.com/device/K111062
Methodology: https://510kreport.com/methodology