# K171407: ExsoMed ArcPhix and ExsoMed ArrowPhix

- Pathway: 510(k) (Traditional)
- Applicant: Exsomed Holding Company, LLC
- Decided: Aug 18, 2017 after 98 days
- Product code: HWC (Screw, Fixation, Bone)
- 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: 1 generation back to K052576 (2005). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052576: Sbi Autofix, Small Bone Innovations, LLC (2005) Summary page 5.

## Indications for use
ExsoMed ArcPhix and ArrowPhix are indicated for use in the surgical fixation of small bones, bone fragments, and osteotomies. The devices are not indicated for soft tissue fixation.

Source page: https://510kreport.com/device/K171407
Methodology: https://510kreport.com/methodology