# K912598: Ace Cortical Bone Screw

- Pathway: 510(k) (Traditional)
- Applicant: Ace Medical Co.
- Decided: Nov 27, 1991 after 170 days
- Product code: HWC (Screw, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3040
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
27 later devices descend from it; 1 cites it directly.
0 of 28 devices in its family (counting itself) have 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
- K970549: Titanium Alloy Bone Screws (1997), 26 descendants of its own
- K023365: Leforte System Bone Screw (2003), 20 descendants of its own
- K131311: Arix Foot System (2013), 9 descendants of its own
- K050669: Jeil Bone Fixation System (2005), 8 descendants of its own
- K161864: ARIX Foot System (2016), 5 descendants of its own

Source page: https://510kreport.com/device/K912598
Methodology: https://510kreport.com/methodology