# K050636: Synthes 3.0MM Headless Compression Screws

- Pathway: 510(k) (Traditional)
- Applicant: Synthes (Usa)
- Decided: Apr 21, 2005 after 41 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.
544 later devices descend from it; 19 cite it directly.
1 of 545 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 its predicate without a number.
- (no number) Synthes 3.0 mm Sterile 3.0 mm Cannulated Screw and Threaded Washer: named in the summary without a submission 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
- K111994: Smith & Nephew Cannulated Screws and Washers (2011), 161 descendants of its own
- K112583: Synthes Cortical Screws (2011), 118 descendants of its own
- K143039: CrossRoads Screw System (2015), 79 descendants of its own

## Recalls of this device
- Sep 12, 2018 · Class II · Z-0238-2019: The product inside the package does not match the label. The product was labeled as long thread screws that have a 6mm thread length but were actually short thread screws with a 4mm thread length.

## Indications for use
The Synthes 3.0 mm Headless Compression Screws are intended for fixation of intra-articular and extra-articular fractures and non-unions of small bones and small bone fragments; arthrodeses of small joints; bunionectomies and ostetotomies. Examples include, but are not limited to scaphoid and other carpal bones, metacarpals, tarsals, metatarsals, patella, ulnar styloid, capitellum, radial head and radial styloid.

Source page: https://510kreport.com/device/K050636
Methodology: https://510kreport.com/methodology