# K094017: Tibial Baseplate Augment Model KC-22118, KC-22128, KC-22138, KC-22148, KC-22158

- Pathway: 510(k) (Special)
- Applicant: Omni Life Science, Inc.
- Decided: Mar 5, 2010 after 66 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: 6 (0 Class I)
- 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.
7 later devices descend from it; 1 cites it directly.
0 of 14 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.
- K031183: Tibial Spacer for the Natural-Knee II Cemented Modular Tibial Baseplate, Centerpulse Orthopedics, Inc. (2003) Summary page 1.

## Most influential descendants
- K101994: Apex Knee Modular  Tibia System (2010), 6 descendants of its own
- 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

## Recalls of this device
- Aug 9, 2012 · Class II · Z-2372-2012: The Apex Knee System Modular Tibia Augment may breach the inner and outer sterile pouches, compromising the sterility
- Aug 9, 2012 · Class II · Z-2370-2012: The Apex Knee System Modular Tibia Augment may breach the inner and outer sterile pouches, compromising the sterility
- Aug 9, 2012 · Class II · Z-2374-2012: The Apex Knee System Modular Tibia Augment may breach the inner and outer sterile pouches, compromising the sterility
- Aug 9, 2012 · Class II · Z-2371-2012: The Apex Knee System Modular Tibia Augment may breach the inner and outer sterile pouches, compromising the sterility
- Aug 9, 2012 · Class II · Z-2373-2012: The Apex Knee System Modular Tibia Augment may breach the inner and outer sterile pouches, compromising the sterility
- Aug 9, 2012 · Class II · Z-2375-2012: The Apex Knee System Modular Tibia Augment may breach the inner and outer sterile pouches, compromising the sterility

## Indications for use
The Apex Knee System Tibial Baseplate Augment is intended for use with the Apex Knee System as a primary or revision total knee replacement. This knee replacement system is intended for cemented fixation and 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.

Source page: https://510kreport.com/device/K094017
Methodology: https://510kreport.com/methodology