# K050275: Modification to: Inion Otps Biodegradable Pin

- Pathway: 510(k) (Special)
- Applicant: Inion, Ltd.
- Decided: Mar 7, 2005 after 28 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: 2 generations back to K901456 (1990). 4 ancestors in all.
51 later devices descend from it; 3 cite it directly.
0 of 56 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031712: Inion Otps Biodegradable Pin, Inion, Ltd. (2003) Summary page 1.

## Most influential descendants
- K061164: Activapin (2006), 37 descendants of its own
- K133636: Extremity Medical Hammertoe Device (2014), 31 descendants of its own
- K141857: CrossTie Intraosseous Fixation System (2015), 16 descendants of its own
- K151270: CrossTIE Intraosseous Fixation System (2015), 15 descendants of its own
- K181872: MIS Bunion System (2019), 14 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/K050275
Methodology: https://510kreport.com/methodology