# K080842: Apex Knee System, Model KC-230XY, KC-240XY [ NO Holes, 2 Holes]

- Pathway: 510(k) (Special)
- Applicant: Omni Life Science, Inc.
- Decided: May 23, 2008 after 59 days
- Product code: MBH (Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer)
- Device class: 2
- Regulation: 21 CFR 888.3565
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K913231 (1991). 18 ancestors in all.
61 later devices descend from it; 1 cites it directly.
0 of 80 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 2.
- K073602: Modification to: Apex Knee System, Omnlife Science (2008) Summary page 2.
- K043123: Apex Modular HA Hip Stem, Apex Surgical, LLC (2005) Summary page 2.

## Most influential descendants
- K131353: Comprehensive Reverse Shoulder - Titanium Glenosphere (2013), 60 descendants of its own
- K140478: Aequalis Reversed Shoulder Prosthesis (2014), 21 descendants of its own
- K193373: Comprehensive® Reverse Shoulder (2020), 20 descendants of its own
- K172502: Comprehensive Augmented Glenoid Components, Comprehensive Standard Baseplate, Comprehensive Mini Baseplate (2018), 20 descendants of its own
- K151293: Aequalis Ascend Flex Shoulder System, Aequalis Reversed Shoulder Prosthesis (2015), 20 descendants of its own

## 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 component may be used uncemented (biological fixation). All other femoral, tibial baseplate, and patellar components are indicated for cemented use only.

Source page: https://510kreport.com/device/K080842
Methodology: https://510kreport.com/methodology