# K061164: Activapin

- Pathway: 510(k) (Traditional)
- Applicant: Bioretec, Ltd.
- Decided: Jul 6, 2006 after 71 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: 3 generations back to K901456 (1990). 6 ancestors in all.
37 later devices descend from it; 6 cite it directly.
0 of 44 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 2.
- K050275: Modification to: Inion Otps Biodegradable Pin, Inion, Ltd. (2005) Summary page 2.
- K003659: Plga Pin, Model 171120,171140,171520,171540,171560,172020,172040,172060,173240,173260, Bionx Implants, Inc. (2001) Summary page 2.

## Most influential descendants
- 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
- K221181: Treace Medical Concepts (TMC) Plating System (2023), 7 descendants of its own

## Indications for use
The ActivaPinTM is indicated for fixation of bone fractures, osteotomies, arthrodeses and osteochondral fractures in the presence of appropriate immobilization.

Source page: https://510kreport.com/device/K061164
Methodology: https://510kreport.com/methodology