# K191765: OMNI TiN Coated Apex Knee™ System

- Pathway: 510(k) (Traditional)
- Applicant: Omni Life Science, Inc.
- Decided: Sep 25, 2019 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: 9 generations back to K982302 (1998). 146 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 149 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K163332: Apex Revision Knee System, Omnilife Science (2017) Summary page 5.
- K163167: CKS Plus Knee System, Consensus Orthopedics, Inc. (2017) Summary page 5.
- K110950: Consensus Knee System, Consensus Orthopedics, Inc. (2011) Summary page 5.
- K122239: Foundation Knee System with Tinbn Coating Foundation PS Knee System with Tinbn Coating 3DKNEE System with Tinbn Coating, Encore Medical L.P. (2013) Summary page 5.
- K020114: 3D KNEE, Encore Orthopedics, Inc. (2002) Summary page 5.
- K143443: VEGA Knee System, Columbus Total Knee System, Aesculap Implants Systems, LLC (2015) Summary page 5.
- K143106: VEGA Knee System, Aesculap Implant Systems, LLC (2014) Summary page 5.
- K120955: Columbus Total Knee System as Columbus Revision Knee System Enduro Knee System, Aesculap Implant Systems, LLC (2012) Summary page 5.
- K101815: Enduro Knee System, Aesculap Implant Systems (2010) Summary page 5.
- (no number) Aesculap Implant Systems - VEGA, Columbus: named in the summary without a submission number

## Most influential descendants
- K252044: Triathlon® Total Knee System - Triathlon® Gold Femoral Components (2025), 0 descendants of its own
- K201611: Apex Knee System (2021), 0 descendants of its own

## Indications for use
The OMNI TiN Coated Apex Knee™ System is intended for use as a primary or revision total knee replacement. This knee replacement system is intended for cemented single use implantation. 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 Knee™ Modular Tibia System Tibial Augments with TiN coating are intended to be bolted to the TiN coated Tibia Baseplate and cemented to the prepared tibia. The Apex Knee Revision Femur System Augments are intended to be bolted to the TiN coated femoral component and cemented to the prepared femur.

Source page: https://510kreport.com/device/K191765
Methodology: https://510kreport.com/methodology