# K061763: Arc Surgical Biotrak Screw

- Pathway: 510(k) (Traditional)
- Applicant: Arc Surgical, LLC
- Decided: Sep 19, 2006 after 89 days
- Product code: HWC (Screw, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3040
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K992301 (1999). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032098: Arthrex Bio-Compression Screw, Small, Arthrex Bio-Compression Screw, Large, Models AR-5024B, AR-5025B, Arthrex, Inc. (2003) Summary page 1.
- K003077: Smartscrew Model 222006...227510, Bionx Implants, Ltd. (2001) Summary page 1.
- K992301: Reunite Screws, Biomet Manufacturing, Inc. (1999) Summary page 1.

## Recalls of this device
- Aug 21, 2009 · Not classified · Z-0073-2010: Labeling may contain 2 lot numbers and 2 model numbers. It was observed that the box top label (30170060-S, W67391) does not match the two side labels (3010320-S, W67385). The part and patient labelin

## Indications for use
The Biotrak TM resorbable compression screw is intended to provide fixation and/or reduction of small bone fractures, osteotomies, and arthrodeses, cancellous fragments, and osteochondral fragments in the upper and lower extremities. Specifically, these indications include osteochondral defects (OCDs), patella rim fractures, tarsal fractures, metatarsal fusions and fractures, metatarsal osteotomies, hallux valgus corrections, humeral condyle fractures, metacarpal fusions and fractures, carpal fusions and fractures, radial head fractures, and distal radius fractures.

Source page: https://510kreport.com/device/K061763
Methodology: https://510kreport.com/methodology