# K133950: Activapin HT, Fuse Link (Private Labled for Footmind, Inc.)

- Pathway: 510(k) (Special)
- Applicant: Bioretec, Ltd.
- Decided: Jan 22, 2014 after 30 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: 5 generations back to K901456 (1990). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061164: Activapin, Bioretec, Ltd. (2006) Summary page 3.
- K080879: Activatm Product Group Including Bioabsorbable Devices Activapin Fusion, Activanailtm Conicaltm, Bioretec, Ltd. (2008) Summary page 2.

## Indications for use
The devices of Blometec: ActivaPln' Product Group including ActivaPinm, ActivaPinN Fusion, AetivaNal' Conical, ActivaNaiM Flat and ActlvaPnM HT are indicated for fixation of bone fractures, osteotomies, arthrodeses and osteochondral fractures in the presence of appropriate immoblization.

Source page: https://510kreport.com/device/K133950
Methodology: https://510kreport.com/methodology