# K081392: Bioretec Activascrew, Activascrew Cannulated and Activascrew Cannulated with Activapin

- Pathway: 510(k) (Special)
- Applicant: Bioretec, Ltd.
- Decided: Jun 18, 2008 after 30 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: 6 generations back to K792022 (1979). 14 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072848: Activascrew, Bioretec, Ltd. (2007) Summary page 1.
- K030900: Inion Otps Biodegradable Fixaton System, Inion, Ltd. (2003) Summary page 1.
- K062617: Modification to Inion Otps Biodegradable Fixation System, Inion, Ltd. (2006) Summary page 1.

## Most influential descendants
- K261057: ActivaScrew™ Cannulated COM (2026), 0 descendants of its own
- K130716: Bioretec Activascrew Interference (2013), 0 descendants of its own

## Indications for use
The ActivaScrew TM Products are indicated for fixation of bone fractures, osteotomies, arthrodeses, bone grafts and osteochondral fractures of upper extremity, ankle and foot in the presence of appropriate immobilization.

Source page: https://510kreport.com/device/K081392
Methodology: https://510kreport.com/methodology