# K050683: Synthes (Usa) 3.5MM Conical Screws

- Pathway: 510(k) (Traditional)
- Applicant: Synthes (Usa)
- Decided: Apr 27, 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.
70 later devices descend from it; 3 cite it directly.
0 of 71 devices in its family (counting itself) have 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 3.5 mm Locking Screws: named in the summary without a submission number

## Most influential descendants
- K082934: Extremity Medical Midfoot Screw System (2009), 63 descendants of its own
- K101700: IO Fix Hand, IO Fix Foot, Extremity Medical Screw System (2010), 56 descendants of its own
- K171018: Axis Charcot Fixation System, 4.5 to 8.5mm Screw System (2017), 24 descendants of its own
- K142581: APTUS Foot System (2015), 22 descendants of its own
- K190586: Monster® Screw System (2019), 21 descendants of its own

## Recalls of this device
- May 13, 2015 · Class II · Z-1800-2015: Certain lots of the 3.7mm Cannulated Locking Screws and 3.7mm Cannulated Conical Screws were found to have been labeled incorrectly.

## Indications for use
The Synthes 3.5 mm Conical Screws are intended to be used with existing Synthes LCP plating systems for fixation and interfiagmentary compression of various bones, such as the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, tibia and fibula, particularly in osteopenic bone.

Source page: https://510kreport.com/device/K050683
Methodology: https://510kreport.com/methodology