# K934643: Ace Humeral Nail

- Pathway: 510(k) (Traditional)
- Applicant: Ace Orthopedic Manufacturing Co.
- Decided: Mar 22, 1994 after 174 days
- Product code: HSB (Rod, Fixation, Intramedullary And Accessories)
- Device class: 2
- Regulation: 21 CFR 888.3020
- 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.
0 of 16 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
- K033878: Ace Antegrade Retrograde Humeral Nail System (2004), 10 descendants of its own
- K181827: Affixus Natural Nail System Humeral Nail (2018), 6 descendants of its own
- K231114: Zimmer® Natural Nail® System Cephalomedullary Nails; Affixus® Natural Nail® Humeral Nail System (2023), 4 descendants of its own
- K051965: Osteobridge Idsf Intramedullary Diaphyseal Segmental Defect Fixation Rod System (2006), 3 descendants of its own
- K241651: Affixus Tibial and Antegrade Femoral Nailing System (2024), 2 descendants of its own

Source page: https://510kreport.com/device/K934643
Methodology: https://510kreport.com/methodology