# K021233: Aap Cannulated Screws

- Pathway: 510(k) (Traditional)
- Applicant: Aap Implantate AG
- Decided: Dec 9, 2002 after 235 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 K810205 (1981). 9 ancestors in all.
181 later devices descend from it; 3 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)
- K990776: Aap Cannulated Screw, 7.5MM, 4.5MM, 4.0MM, 3.5MM, 7.0MM, Aap Implantate AG (1999) Summary page 1.
- K915316: Aap Bone Screw, Aap International, Ltd. (1992) Summary page 1.
- K950652: Osteotech Navicular and Cancellous Cannulated Screws, Osteotech, Inc. (1995) Summary page 1.
- K962011: Synthes 7.0/7.3 MM Cannulated Screws, Synthes (Usa) (1996) Summary page 1.
- K963192: Synthes Sterile 3.5 MM and 4.0 MM Cannulated Screws, Synthes (Usa) (1996) Summary page 1.
- K895766: Asnis II Guided Bone Screw, Howmedica Corp. (1989) Summary page 1.
- K962706: EZ-Fix Cannulated Screw System, Biodynamic Technologies, Inc. (1996) Summary page 1.
- K893512: Depuy Cannulated Bone Screw, Depuy, Inc. (1989) Summary page 1.
- K810205: Mecron Cancellous Cannulated Bone Screws, Serrano Intl. (1981) Summary page 1.
- (no number) ZIMMER MAGNA-Fx Et Mini Magna-Fx Cannulated Screw Fixation System (Stainless Steel): named in the summary without a submission number

## Most influential descendants
- K080101: Aap Cannulated Screw and Darco Headed Screw (2008), 180 descendants of its own
- 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

## Indications for use
The aap Small and Large Cannulated Screw System is 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 Fractures of the head of the humerus Fractures of the head of the tibia Cooper fractures of the tibia 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 Malleolar fractures 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/K021233
Methodology: https://510kreport.com/methodology