# K944330: Acutrak Plus Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Acu Med, Inc.
- Decided: May 5, 1995 after 241 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.
172 later devices descend from it; 8 cite it directly.
0 of 173 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
- K051309: Roi Fusion Rods & Plates (2005), 145 descendants of its own
- K080398: SI Joint Fusion System (2008), 144 descendants of its own
- K110838: Ifuse Implant System (2011), 143 descendants of its own
- K122074: Ifuse Implant System (2012), 139 descendants of its own
- K123850: Ifuse Implant System (2013), 134 descendants of its own

Source page: https://510kreport.com/device/K944330
Methodology: https://510kreport.com/methodology