# K071616: Arc Surgical Biotrak Pin System

- Pathway: 510(k) (Traditional)
- Applicant: Arc Surgical, LLC
- Decided: Dec 19, 2007 after 189 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: 6 generations back to K864912 (1987). 15 ancestors in all.
No later device cites it as a predicate yet.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041288: Modification to Smartpin, Linvatec Biomaterials, Inc. (2004) Summary page 1.
- K011522: Resorbable Bone Pins, Biomet, Inc. (2001)
- K050259: Arthrex Bio-Pin, Arthrex, Inc. (2005) Summary page 1.
- K991971: Arthrex Chondral Dart, Model AR-4005B-18, Arthrex, Inc. (2000) Summary page 1.

## Indications for use
The BIOTIAKTM Pin is intended for use in fixation and/or alignment of fragments and fractures of non-load bearing bones, osteotomies, arthrodeses, cancellous fragments, and osteochondral fragments in the upper and lower extremities.

Source page: https://510kreport.com/device/K071616
Methodology: https://510kreport.com/methodology