# K080879: Activatm Product Group Including Bioabsorbable Devices Activapin Fusion, Activanailtm Conicaltm

- Pathway: 510(k) (Traditional)
- Applicant: Bioretec, Ltd.
- Decided: Jun 24, 2008 after 85 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: 4 generations back to K901456 (1990). 7 ancestors in all.
1 later device descends from it; 1 cites it directly.
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 2.

## Most influential descendants
- K133950: Activapin HT, Fuse Link (Private Labled for Footmind, Inc.) (2014), 0 descendants of its own

## Indications for use
The devices of Bioretec ActivaPin Product Group including ActivaPin, ActivaPin Fusion, ActivaNail Conical and ActivaNail Flat are indicated for fixation of bone fractures, osteotomies, arthrodeses and osteochondral fractures in the presence of appropriate immobilization.

Source page: https://510kreport.com/device/K080879
Methodology: https://510kreport.com/methodology