# K942340: Cortical Bone Screw

- Pathway: 510(k) (Traditional)
- Applicant: Acu Med, Inc.
- Decided: Dec 5, 1994 after 203 days
- Product code: HWC (Screw, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3040
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
34 later devices descend from it; 1 cites it directly.
0 of 35 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
- K061206: Acute Bone Screw (2006), 33 descendants of its own
- 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

## Recalls of this device
- May 19, 2009 · Not classified · Z-1602-2010: Mix-up of parts - Product labeled cortical bone screw actually contains Acutract fixation screw
- Jul 9, 2007 · Not classified · Z-2135-2008: Product mislabeled. The inner sticky labels for the patient identified the product incorrectly as a Cortical screw (non-locking). The product package was labeled correctly.
- Dec 27, 2005 · Not classified · Z-2155-2008: Package of 3.5mm X 32.5mm cortical screw may contain 3.5mm X 22.5mm cortical screw.

Source page: https://510kreport.com/device/K942340
Methodology: https://510kreport.com/methodology