# K012945: Synthes 2.4 MM Cannulated Screw

- Pathway: 510(k) (Traditional)
- Applicant: Synthes (Usa)
- Decided: Dec 3, 2001 after 90 days
- Product code: HWC (Screw, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3040
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
711 later devices descend from it; 10 cite it directly.
1 of 712 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K090675: Smith & Nephew, Inc. VLP Foot Plating, Screw System and Accessories (2009), 487 descendants of its own
- K100776: Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot System (2010), 228 descendants of its own
- K102343: Emerge Medical Cannulated Screw Fixation System (2010), 220 descendants of its own
- K103705: Low Profile Screws (2011), 219 descendants of its own
- K082874: Biodrive Cannulated Screw System (2009), 168 descendants of its own

## Recalls of this device
- Feb 12, 2013 · Class II · Z-0890-2013: Out of specification result - stability test failure of free available chlorine (FAC) which functions as a preservative for the hydrogel. The 13 month test result obtained was 4 ppm FAC and the stabil

## Indications for use
The Synthes 2.4 mm Cannulated Screw is intended for fixation of fractures and non-unions of small bones and small bone arthrodeses. Examples include, but are not limited to scaphoid and other carpal fractures, metacarpal and phalangeal fusions, osteotomies, and bunionectomies.

Source page: https://510kreport.com/device/K012945
Methodology: https://510kreport.com/methodology