# K080101: Aap Cannulated Screw and Darco Headed Screw

- Pathway: 510(k) (Special)
- Applicant: Aap Implantate AG
- Decided: Mar 25, 2008 after 71 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: 2 generations back to K810205 (1981). 10 ancestors in all.
180 later devices descend from it; 4 cite it directly.
1 of 191 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021233: Aap Cannulated Screws, Aap Implantate AG (2002) Summary page 2.
- K990776: Aap Cannulated Screw, 7.5MM, 4.5MM, 4.0MM, 3.5MM, 7.0MM, Aap Implantate AG (1999) Summary page 2.

## Most influential descendants
- K100359: Darco Headed Cannulated Screw (2010), 145 descendants of its own
- 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

## Indications for use
The nap Cannulated Screws are intended for use over a guide pin or wire for bone fracture fixation and bone fragment fixation. aap's washers may be used with the screws in certain applications. * Minimally invasive fracture /joint reconstructions * Additive osteosynthesis for complex joint fractures * Multiple- fragment joint fractures * Femoral neck and femoral head fractures Femoral supracondylar fractures Tibial plateau 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 Fractures of the acetabulum Fractures of the dorsal pelvic ring Condylar fractures Peadiatric epiphyseal and metaphyseal fractures * 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 metatarsl V * Fractures of the tarsal region

Source page: https://510kreport.com/device/K080101
Methodology: https://510kreport.com/methodology