# K905048: Ace 3.5MM Cortical Bone Screw

- Pathway: 510(k) (Traditional)
- Applicant: Ace Medical Co.
- Decided: Jan 30, 1991 after 83 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.
81 later devices descend from it; 3 cite it directly.
0 of 82 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
- K072832: Anterolateral and Medial Locking Plating System (2007), 58 descendants of its own
- K092812: Synthes (Usa) 2.7MM/ 3.5MM LCP Anterolateral Distal Tibia Plates (2010), 55 descendants of its own
- K072083: Small Fragment Locking Plating System (2007), 37 descendants of its own
- K101421: Medical Plates, Lateral Plates, Posterior Lateral Plates, Olecranon Plates Model 131218704-708; 851318704-708, 131218204 (2010), 32 descendants of its own
- K162674: BioPro Foot Plating Systems (2017), 19 descendants of its own

Source page: https://510kreport.com/device/K905048
Methodology: https://510kreport.com/methodology