# K062617: Modification to Inion Otps Biodegradable Fixation System

- Pathway: 510(k) (Special)
- Applicant: Inion, Ltd.
- Decided: Oct 4, 2006 after 29 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). 12 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 16 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 1.

## Most influential descendants
- K081392: Bioretec Activascrew, Activascrew Cannulated and Activascrew Cannulated with Activapin (2008), 2 descendants of its own
- K261057: ActivaScrew™ Cannulated COM (2026), 0 descendants of its own
- K130716: Bioretec Activascrew Interference (2013), 0 descendants of its own

## Indications for use
These INION OTPSTM BIODEGRADABLE FIXATION SYSTEM implants are generally intended for maintenance of reduction and fixation of cancellous bone fractures, osteotomies or arthrodeses of the upper extremity, ankle and foot in the presence of appropriate brace and/or immobilization. Specific indications: * Fractures and osteotomies of the malleoli * Ankle fractures

Source page: https://510kreport.com/device/K062617
Methodology: https://510kreport.com/methodology