# K061206: Acute Bone Screw

- Pathway: 510(k) (Traditional)
- Applicant: Acute Innovations, LLC
- Decided: Jun 19, 2006 after 49 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: 1 generation back to K942340 (1994). 2 ancestors in all.
33 later devices descend from it; 1 cites it directly.
0 of 36 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K024169: Macropore OS Reconstruction, Macropore Biosurgery, Inc. (2003) Summary page 1.
- K942340: Cortical Bone Screw, Acu Med, Inc. (1994) Summary page 1.

## Most influential descendants
- K073556: Medxpert P.E.S. (Pectus Exacvatum System), Medxpert Stratos (2008), 32 descendants of its own
- K133616: Matrixrib Fixation System (2014), 26 descendants of its own
- K142823: Biomet Microfixation Thoracic Fixation System (2015), 23 descendants of its own
- K151173: Biomet Microfixation RibFix Blu Thoracic Fixation System (2015), 13 descendants of its own
- K152253: Biomet Microfixation RibFix Blu Thoracic Fixation System (2016), 11 descendants of its own

## Indications for use
The Acute Bone Screw is a general purpose screw intended to stabilize and provide fixation for fractures, fusions, and osteotomies of the thorax (ribs, sternum, clavicle, scapula).

Source page: https://510kreport.com/device/K061206
Methodology: https://510kreport.com/methodology