# K130954: Ars Screw; Slant Screw

- Pathway: 510(k) (Traditional)
- Applicant: Advanced Interventional Technology, LLC
- Decided: May 31, 2013 after 56 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: 5 generations back to K962823 (1996). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071639: Qwix Positioning Screw, Newdeal Sas (2007) Summary page 2.
- K050346: Stabilization Screw, New Deal, S.A. (2005) Summary page 2.

## Indications for use
The ARS and SLANT SCREW medical devices are indicated for the fixation of bone fractures and bone reconstruction. Examples include but are not limited to: * Fixation of bone fragments in long or small bone fractures *arthrodesis in hand or foot surgery *mono or bi-cortical osteotomies in the foot or hand *distal or proximal metatarsal or metacarpal osteotomies *fixation of osteotomies for hallux valgus treatment (such as Scarf, Chevron, etc.)

Source page: https://510kreport.com/device/K130954
Methodology: https://510kreport.com/methodology