# K031712: Inion Otps Biodegradable Pin

- Pathway: 510(k) (Traditional)
- Applicant: Inion, Ltd.
- Decided: Aug 28, 2003 after 87 days
- Product code: HTY (Pin, Fixation, Smooth)
- 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: 1 generation back to K901456 (1990). 3 ancestors in all.
382 later devices descend from it; 7 cite it directly.
0 of 386 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K010983: Plla Pin, Bionx Implants, Inc. (2001) Summary page 1.
- K901456: Orthosorb (R) Absorbable Pin, Johnson & Johnson International (1990) Summary page 1.
- K961608: Synthes (U.S.a.) Polypin, Synthes (Usa) (1997) Summary page 1.

## Most influential descendants
- K033717: Transet Fracture Fixation System (2004), 309 descendants of its own
- 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

## Indications for use
The Inion OTPSTM Biodegradable Pin is indicated for maintenance of alignment and fixation of bone fractures, osteotomies, arthrodeses or bone grafts in the presence of appropriate additional immobilization (e.g. rigid fixation implants, cast, brace).

Source page: https://510kreport.com/device/K031712
Methodology: https://510kreport.com/methodology