# K951673: Rod, Fixation, Intramedullary and Accessories

- Pathway: 510(k) (Traditional)
- Applicant: Acu Med, Inc.
- Decided: Jul 6, 1995 after 86 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.
36 later devices descend from it; 2 cite it directly.
0 of 37 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
- K031438: Acumed Small Bone Locking Rod System II (2003), 24 descendants of its own
- K071944: Acumed Small Bone Locking System II (2007), 15 descendants of its own
- K143276: Acumed Small Bone IM Nail System (2015), 10 descendants of its own
- K142945: Sonoma Fibula Repair System (2015), 10 descendants of its own
- K132945: CFN-Cannulated Femur Nail, CTN-Cannulated Tibia Nail, CHN-Cannulated Humeral Nail (2014), 10 descendants of its own

Source page: https://510kreport.com/device/K951673
Methodology: https://510kreport.com/methodology