# K011946: The Spin Snap-Off Screw

- Pathway: 510(k) (Traditional)
- Applicant: New Deal, S.A.
- Decided: Aug 24, 2001 after 64 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: 2 generations back to K924138 (1993). 7 ancestors in all.
6 later devices descend from it; 4 cite it directly.
0 of 14 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.
- K962233: Twist-Off Screw, Landos, Inc. (1996) Summary page 2.
- K950595: Luhr Mandibular/Small Fixation Implants, Howmedica Corp. (1995) Summary page 2.
- K952272: TI. Alloy 2.0 MM Cortex Screw, Synthes (Usa) (1995) Summary page 2.
- K002271: 2.4MM Cortex Screw, Self-Tapping, Synthes (Usa) (2000) Summary page 2.
- K924018: M3 Lag Screw Fixation System, Osteomed Corp. (1993) Summary page 2.
- K924138: Osteomed M3 System (SBF System), Osteomed Corp. (1993) Summary page 2.

## Most influential descendants
- K051323: Merete Twistcut Snap-Off Bone Screw (2005), 2 descendants of its own
- K253108: VEOFIX Snap Off Screw (2026), 0 descendants of its own
- K210016: Integra DigiFuse Cannulated Intramedullary Fusion System,Integra Total Foot System,Integra CAPTURE Screw System & Integra Ti6 Internal Fixation System,Subtalar MBA System,MetaSurg Subtalar Implant,NewDeal BOLD Screw,NewDeal HALLU Lock Plate System,NewDeal HALLU Plates,QWIX Positioning Screw,SPIN Snap-Off Screw,NewDeal TIBIAXYS System (2021), 0 descendants of its own
- K163710: BePOD® EZ Weil Screws (2017), 0 descendants of its own
- K170012: Foot and Hand Motion (2017), 0 descendants of its own

## Indications for use
The “new” SPIN® SNAP-OFF SCREW is indicated for fixation of bone fractures or for bone reconstruction. Examples include: Fixation of small bone fragments. Weil osteotomy Mono-cortical fixation Osteotomies and fractures fixation in the foot and hand

Source page: https://510kreport.com/device/K011946
Methodology: https://510kreport.com/methodology