# K111230: Synthes 3.5MM Low Profile Cortical Screw

- Pathway: 510(k) (Traditional)
- Applicant: Synthes (USA) Products, LLC
- Decided: May 24, 2011 after 22 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
Longest line of descent: 1 generation back to K043185 (2005). 1 ancestor in all.
122 later devices descend from it; 3 cite it directly.
0 of 124 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K043185: Synthes 3.5MM Cortex Screws, Synthes (Usa) (2005) Summary page 1.

## Most influential descendants
- K112583: Synthes Cortical Screws (2011), 118 descendants of its own
- K120854: Synthes VA LCP Ankle Trauma System (2012), 44 descendants of its own
- K161616: DePuy Synthes 4.0 mm and 4.5 mm Cortex Screws, DePuy Synthes 2.4 mm Cannulated Screws, DePuy Synthes 3.5 mm and 4.0 mm Cannulated Screws, DePuy Synthes 4.5 mm Cannulated Screws, DePuy Synthes 6.5 mm Cannulated Screws, DePuy Synthes 7.0 mm and 7.3 mm Cannulated Screws, DePuy Synthes 1.5 mm Headless Compression Screws, DePuy Synthes 2.4 mm Headless Compression Screws, DePuy Synthes 3.0 mm Headless Compression Screws, DePuy Synthes 4.5 mm and 6.5 mm Headless Compression Screw (2017), 33 descendants of its own
- K143385: Acumed Ankle Plating System (2015), 23 descendants of its own
- K151886: Acumed Ankle and Small Fragment Base Set Update (2015), 15 descendants of its own

## Indications for use
The Synthes 3.5mm Low Profile Contical 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 in adults, and in both children (2-12 years) and adolescents (12-21 years) in which grow~h plates have fused or in which growth plates will not be crossed by the screw fixation.

Source page: https://510kreport.com/device/K111230
Methodology: https://510kreport.com/methodology