# K100359: Darco Headed Cannulated Screw

- Pathway: 510(k) (Traditional)
- Applicant: Wrightmedicaltechnologyinc
- Decided: Jun 24, 2010 after 132 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: 3 generations back to K810205 (1981). 11 ancestors in all.
145 later devices descend from it; 6 cite it directly.
1 of 157 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080101: Aap Cannulated Screw and Darco Headed Screw, Aap Implantate AG (2008) Summary page 1.

## Most influential descendants
- K143039: CrossRoads Screw System (2015), 79 descendants of its own
- K162825: CAPTIVATE™ Compression Screws (2017), 74 descendants of its own
- K171651: Excelsius GPS (2017), 69 descendants of its own
- K111678: Ortho Solutions Extremity Fixation Implants for Osteosysnthesis (2012), 58 descendants of its own
- K191100: ExcelsiusGPS Spine 1.1 Interbody Module (2019), 42 descendants of its own

## Indications for use
The DARCOS Headed Cannulated Screws are intended for use over a guide pin or wire for bone fracture fixation and bone fragment fixation. Wright Medical's washers may be used with the screws in cases where the patient has poor bone quality. * Minimally invasive fracture / joint reconstructions * Multiple- fragment joint fractures * Simple metaphyseal fractures * Simple epiphyseal fractures o Fractures of the head of the humerus o Fractures of the head of the tibia o Cooper fractures of the tibia o Fractures of the radius * Fractures of the wrist, ankle, elbow and shoulder * Scaphoid fractures and other fractures of the hand * Metatarsal fractures and other fractures of the foot * Ligament fixation of the proximal humerus * Ligament avulsion injuries (Apohysis) * Fractures of small joint bones o Malleolar fractures o Navicular fractures * Fractures of the calcaneus and talus * Arthrodesis of the ankle joint * Avulsion fracture and metatarsal V * Fractures of the tarsal region

Source page: https://510kreport.com/device/K100359
Methodology: https://510kreport.com/methodology