# K213614: Cannulated Screws

- Pathway: 510(k) (Traditional)
- Applicant: Maxxion Medical, LLC
- Decided: Aug 3, 2022 after 261 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: 13 generations back to K000684 (2000). 129 ancestors in all.
No later device cites it as a predicate yet.
0 of 130 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K201132: Arthrex Compression Screws, Arthrex, Inc. (2020) Summary page 5.
- K202589: APTUS Cannulated Compression Screws, APTUS headed Cannulated Compression Screws, APTUS K-Wire System, Medartis AG (2020) Summary page 5.

## Indications for use
Cannulated Screw and Double Compression Cannulated Screw are intended for the treatment of fractures, osteotomies, and arthrodesis of bones with the appropriate screw size. The Cannulated Compression Taper Screw (2.5-3.0 mm cannulated) are intended to be used as stand-alone bone screws for internal bone fixation for bone fractures, fusions, osteotomies and non-unions in the ankle, foot, hand, and wrist. The Cannulated Compression Taper Screw (3.5 mm and larger, cannulated) are intended to be used as stand-alone bone screws for internal bone fixation for bone fractures, fusions, osteotomies and non-unions in the ankle, foot, hand, wrist, clavicle, scapula, olecranon, humerus, radius, ulna, tibia, calcaneus, femur, and fibula.

Source page: https://510kreport.com/device/K213614
Methodology: https://510kreport.com/methodology