# K261057: ActivaScrew™ Cannulated COM

- Pathway: 510(k) (Traditional)
- Applicant: Bioretec, Ltd.
- Decided: Sep 4, 2026 after 157 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: 7 generations back to K792022 (1979). 15 ancestors in all.
No later device cites it as a predicate yet.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081392: Bioretec Activascrew, Activascrew Cannulated and Activascrew Cannulated with Activapin, Bioretec, Ltd. (2008) Summary page 5.

## Indications for use
ActivaScrew™ Cannulated COM is indicated for fixation of bone and osteochondral fractures, osteotomies, arthrodeses, and bone grafts of the upper (hand, non-diaphyseal arm & forearm) and lower (foot, non-diaphyseal ankle) extremities in the presence of appropriate immobilization. ActivaScrew™ Cannulated COM is intended to be used for skeletally mature adults.

Source page: https://510kreport.com/device/K261057
Methodology: https://510kreport.com/methodology