# K112583: Synthes Cortical Screws

- Pathway: 510(k) (Traditional)
- Applicant: Synthes (USA) Products, LLC
- Decided: Dec 5, 2011 after 90 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: 10 generations back to K962616 (1996). 85 ancestors in all.
118 later devices descend from it; 28 cite it directly.
0 of 204 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030310: Synthes Stainless Steel Modular Hand System, Synthes (Usa) (2003) Summary page 1.
- K010321: Modular Foot System - 2.7 MM Module, Synthes (Usa) (2001)
- K043185: Synthes 3.5MM Cortex Screws, Synthes (Usa) (2005) Summary page 1.
- K111230: Synthes 3.5MM Low Profile Cortical Screw, Synthes (USA) Products, LLC (2011)
- K000684: Small Fragment Dynamic Compression Locking (DCL) System, Synthes (Usa) (2000) Summary page 1.
- K000682: Synthes Large Fragment Dynamic Compression Locking (DCL) System, Synthes (Usa) (2000) Summary page 1.
- K100776: Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot System, Synthes (Usa) (2010) Summary page 1.
- K023879: Small Titanium Wrist Fusion Plate, Synthes (Usa) (2003) Summary page 1.

## Most influential descendants
- 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
- K181113: CoLink™ Afx Plating System (2018), 14 descendants of its own

## Indications for use
The Synthes I .0mm, 1.3num, 1.5mm, 2.0mm, and 2.4mm Cortex Screws are intended for use in trauma procedures, reconstructive procedures, and general surgery of the hand, wrist, and other small bones and bone fragments in adults and in both children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by screw fixation. The Synthes 2.7mm Cortex Screw is intended for fractures and osteotomnies of small bones and bone fragments, including the foot, ankle, and hand in adults and in both children (2-.12 years) and adolescents (12-21 years) in which growth plates hlave fused or in which growth plates will not be crossed by screw fixation. The Synthes 2.7mm Cortex Screw may also be used in fusion applications in adults and adolescents (12-2lyears) when used with the Synthes 2.4mmn/2.7mm Variable Angle LCP Fore foot/M idfoot System (K100776) and in adults and pediatric patients (2-12 years) when used with the Synthes Ti Wrist Fusion Plate (K023879). The Synthies 3.5mm and 4.0mmn 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 in adults and in both children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by screw fixation. The Synthes 4.5imm Cortex Screw is intended for fixation of various long bones, such as the humerus, femur and tibia. It is also for use in fixation of non-unions or malunions in adults and in both children (2-12 years) and adolescents (12-2 1 years) in which growth plates have fused or in which growth plates will not be crossed by screw fixation.

Source page: https://510kreport.com/device/K112583
Methodology: https://510kreport.com/methodology