# K951740: Intramedulary Fixation Rod

- Pathway: 510(k) (Traditional)
- Applicant: Acu Med, Inc.
- Decided: Aug 11, 1995 after 140 days
- Product code: HSB (Rod, Fixation, Intramedullary And Accessories)
- Device class: 2
- Regulation: 21 CFR 888.3020
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
113 later devices descend from it; 5 cite it directly.
0 of 114 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
- K032722: Trigen Straight Humeral Nail System (2003), 100 descendants of its own
- K051557: Trigen Retrograde Femoral, Supracondylar and Tibial Nails (2005), 69 descendants of its own
- K061019: Trigen Meta-Nail Retrograde Femoral and Tibial Nails (2006), 60 descendants of its own
- K100497: Quantum IM Composite Nailing System (Quantum Nailing System) (2010), 29 descendants of its own
- K082754: Aequalis Humeral Nail System (2009), 22 descendants of its own

## Recalls of this device
- Mar 7, 2012 · Not classified · Z-1357-2012: The packaging contains the wrong product. It does not contain model HR-0824-S as the package indicates.

Source page: https://510kreport.com/device/K951740
Methodology: https://510kreport.com/methodology