# K914574: Exactech Ceramic Femoral Head Component

- Pathway: 510(k) (Traditional)
- Applicant: Exactech, Inc.
- Decided: Jan 13, 1992 after 90 days
- Product code: LZO (Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3353
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
26 later devices descend from it; 1 cites it directly.
0 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K032964: Exactech 12/14 Alumina Femoral Head; Exactech Acumatch M-Series 12/14 Neck Segments (2003), 25 descendants of its own
- K073337: Mectacer Biolox Forte-Femoral Heads (2008), 16 descendants of its own
- K112115: Mectacer Biolox (R) Delta Femoral Heads (2011), 14 descendants of its own
- K121665: Bencox Foret & Bencox Delta (2012), 8 descendants of its own
- K150007: Modified Bencox Hip System (2015), 7 descendants of its own

Source page: https://510kreport.com/device/K914574
Methodology: https://510kreport.com/methodology