# K043185: Synthes 3.5MM Cortex Screws

- Pathway: 510(k) (Traditional)
- Applicant: Synthes (Usa)
- Decided: Feb 3, 2005 after 78 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
No predicates in its family tree.
405 later devices descend from it; 20 cite it directly.
0 of 406 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 Cortex Screws: named in the summary without a submission number

## Most influential descendants
- K103705: Low Profile Screws (2011), 219 descendants of its own
- K111253: Arthrex Distal Extremity Plate System (2011), 135 descendants of its own
- K111230: Synthes 3.5MM Low Profile Cortical Screw (2011), 122 descendants of its own
- K112583: Synthes Cortical Screws (2011), 118 descendants of its own
- K112437: Arthrex Fracture System (2011), 91 descendants of its own

## Indications for use
The Synthes 3.5 mm Cortex Screws are intended for fixation of fractures, osteotomies and non-unions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, tibia, calcaneous, femur and fibula.

Source page: https://510kreport.com/device/K043185
Methodology: https://510kreport.com/methodology