# K062980: Activascrew

- Pathway: 510(k) (Traditional)
- Applicant: Bioretec, Ltd.
- Decided: Nov 22, 2006 after 54 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: 5 generations back to K792022 (1979). 18 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030900: Inion Otps Biodegradable Fixaton System, Inion, Ltd. (2003) Summary page 2.
- K061164: Activapin, Bioretec, Ltd. (2006)

## Most influential descendants
- K130716: Bioretec Activascrew Interference (2013), 0 descendants of its own

## Indications for use
The ActivaScrew TM is 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/K062980
Methodology: https://510kreport.com/methodology