# K230744: Acumed Acutrak 3 Headless Compression Screw System

- Pathway: 510(k) (Traditional)
- Applicant: Acumed, LLC
- Decided: Jun 9, 2023 after 84 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
Longest line of descent: 7 generations back to K962823 (1996). 35 ancestors in all.
1 later device descends from it; 1 cites 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)
- K202680: OsteoMed ExtremiFix Mini & Small Cannulated Screw System, Osteomed, LLC (2020) Summary page 4.
- K163303: OsteoMed ExtremiFix Mid and Large Screw System, Osteomed, LLC (2017) Summary page 4.
- K063298: Osteomed Headless Cannulated Screw System, Osteomed LP (2007) Summary page 4.
- K110658: Aptus Cannulated Compression Screws, Medartis AG (2011) Summary page 4.

## Most influential descendants
- K250251: Eleganz Fusion Screw System (Fusion Screw System) (2025), 0 descendants of its own

## Indications for use
Acutrak 3 Headless Compression Screw System screws are indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation of bones appropriate for the size of the device. The screws are not intended for interference or soft tissue fixation.

Source page: https://510kreport.com/device/K230744
Methodology: https://510kreport.com/methodology