# K030900: Inion Otps Biodegradable Fixaton System

- Pathway: 510(k) (Traditional)
- Applicant: Inion, Ltd.
- Decided: Jun 19, 2003 after 87 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: 4 generations back to K792022 (1979). 11 ancestors in all.
333 later devices descend from it; 8 cite it directly.
0 of 345 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012001: Smartscrew, Bionx Implants, Ltd. (2001) Summary page 1.
- K003077: Smartscrew Model 222006...227510, Bionx Implants, Ltd. (2001) Summary page 1.
- K964970: Biomet Bone Screw, Biomet, Inc. (1997) Summary page 1.

## Most influential descendants
- K043248: Tightrope Syndesmosis Repair Kit, Titanium, Model AR-8920DS; Stainless Steel. Model AR-8921DS (2005), 306 descendants of its own
- K052776: Tightrope Acromioclavicular (AC) Device, Titanium, Stainless Steel , Models AR-2257, AR-TBD (2005), 217 descendants of its own
- K083070: Toggleloc System (2008), 94 descendants of its own
- K112437: Arthrex Fracture System (2011), 91 descendants of its own
- K123241: Arthrex Fracture Plates (2013), 71 descendants of its own

## Indications for use
The Inion OTPS Biodegradable Fixation System is 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 andor immobilization. Specific indications: Fractures and osteotomies of the malleoli Ankle fractures

Source page: https://510kreport.com/device/K030900
Methodology: https://510kreport.com/methodology