# K071863: Activapin, Nexfix RFS Pin, Nexfix Resorbable Fixation System (RFS)

- Pathway: 510(k) (Special)
- Applicant: Bioretec, Ltd.
- Decided: Aug 31, 2007 after 56 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.
No later device cites it as a predicate yet.
0 of 8 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 1.

## 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/K071863
Methodology: https://510kreport.com/methodology