# K141949: Cortical Screw 3.5, T15, Self-Tapping, Titanium, Cortical Screw 4.5, T25, Self Tapping, Titanium

- Pathway: 510(k) (Traditional)
- Applicant: Aap Implantate AG
- Decided: Sep 12, 2014 after 56 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: 4 generations back to K000684 (2000). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072411: Aap Bone Plates and Screw Implants, Aap Implantate AG (2008) Summary page 4.
- K113652: Loqteq Small Fragment Set Loqteq Cortical SCREW3.5, Small Head, T15, Self Tapping Loqteq Cortical Screw 3.5, T15, Self T, Aap Implantate AG (2012) Summary page 4.
- K113648: Loqteq Large Fragment Set Loqteq Cortical Screw 4.5, Small Head, T25, Self Tapping Loqteq Cortical Screw 4.5, T25, Self, Aap Implantate AG (2012) Summary page 4.

## Indications for use
The devices are intended to treat fractures of various bones, including the clavicle, scapula, pelvis, long bone (humerus, ulna, radius, femur, tibia and fibula), and small bone (metacarpals, metatarsals, and phalanges) according to the standard of the AO Foundation (AO Principles of Fracture Management). All aap bone screws are for single use only and are not intended for any spinal fixation procedures.

Source page: https://510kreport.com/device/K141949
Methodology: https://510kreport.com/methodology