# K893685: Ceramic Femoral Head

- Pathway: 510(k) (Traditional)
- Applicant: Dow Corning Wright
- Decided: Sep 26, 1989 after 133 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.
15 later devices descend from it; 2 cite it directly.
1 of 16 devices in its family (counting itself) has a Class I recall.

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

## Most influential descendants
- K100866: Profemur Hip System Modular Necks (2010), 14 descendants of its own
- K112080: Preserve Hip Stem (2011), 8 descendants of its own
- K111910: Gladiator Hip Stem (2011), 5 descendants of its own
- K150302: PROFEMUR Preserve Classic Stem (2015), 4 descendants of its own
- K112150: Profemur Gladiator HA Hip Stem (2011), 4 descendants of its own

Source page: https://510kreport.com/device/K893685
Methodology: https://510kreport.com/methodology