# K101994: Apex Knee Modular  Tibia System

- Pathway: 510(k) (Traditional)
- Applicant: Omnlife Science
- Decided: Sep 28, 2010 after 75 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: 5 generations back to K982302 (1998). 32 ancestors in all.
6 later devices descend from it; 1 cites it directly.
0 of 39 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.
- K094017: Tibial Baseplate Augment Model KC-22118, KC-22128, KC-22138, KC-22148, KC-22158, Omni Life Science, Inc. (2010) Summary page 1.
- K080361: Regenerex Tibial Components, Biomet, Inc. (2008) Summary page 1.

## Most influential descendants
- K131472: Apex Knee Modular Tibia System (2013), 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
- K252044: Triathlon® Total Knee System - Triathlon® Gold Femoral Components (2025), 0 descendants of its own

## Recalls of this device
- May 23, 2025 · Class II · Z-2069-2025: Investigation has identified that the age of the nylon packaging material has caused a loss of integrity of some pouches.

## Indications for use
The Apex Knee TM 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 uncemnented (biological fixation). The porous coated tibial baseplate component may be used uncemented (biological fixation). All other femoral, tibia] baseplate and patellar components are indicated for cemented use only. The Apex Knee T" 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/K101994
Methodology: https://510kreport.com/methodology