# K132911: I.B.S Snap-Off Screw / Solafix Snap-Off Screw

- Pathway: 510(k) (Traditional)
- Applicant: In2bones Sas
- Decided: Apr 4, 2014 after 199 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: 7 generations back to K000684 (2000). 32 ancestors in all.
No later device cites it as a predicate yet.
0 of 33 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K991477: Spin Snap-Off Screw, New Deal, S.A. (1999) Summary page 2.
- K103705: Low Profile Screws, Arthrex, Inc. (2011) Summary page 3.
- K053394: Nexa Bone Screw System, Nexa Orthopedics, Inc. (2005) Summary page 2.

## Indications for use
The I.B.S. snap-off screws are intended for bone reconstruction, osteotomy and fracture fixation of bones appropriate for the size of the device. Examples include: Mono-conical fixation of small bone fragments Weil osteotomy Osteotomies and fractures fixation in the foot and hand.

Source page: https://510kreport.com/device/K132911
Methodology: https://510kreport.com/methodology