# K050346: Stabilization Screw

- Pathway: 510(k) (Traditional)
- Applicant: New Deal, S.A.
- Decided: Mar 17, 2005 after 34 days
- Product code: HWC (Screw, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3040
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K962823 (1996). 8 ancestors in all.
55 later devices descend from it; 5 cite it directly.
0 of 64 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011262: Modification to the Bold Screw, New Deal, S.A. (2001) Summary page 2.
- K971070: Scarf Thread-Head (TM) Head Screw, Landos, Inc. (1997) Summary page 2.
- K011821: Modification to the I.C.O.S Screw, New Deal, S.A. (2001) Summary page 2.
- K963172: Synthes Sterile 4.5 MM Cannulated Screws, Synthes (Usa) (1996) Summary page 2.

## Most influential descendants
- K071639: Qwix Positioning Screw (2007), 52 descendants of its own
- K091798: Merete Compression Screws (2009), 26 descendants of its own
- K131722: I.T.S. Extremity Fixation Systems (2013), 24 descendants of its own
- K131920: Stabilization Screw (2014), 18 descendants of its own
- K160174: I.B.S. 2.0 Osteosynthesis screw (2016), 17 descendants of its own

## Recalls of this device
- Feb 8, 2010 · Not classified · Z-1254-2010: The screws were etched incorrectly as 32mm instead of the correct 34mm length.
- Feb 8, 2010 · Not classified · Z-1253-2010: The screws were etched incorrectly as 34mm instead of the correct 32mm.
- Feb 27, 2008 · Not classified · Z-1445-2008: Certain QWIX Fixation Screws (Reference numbers 111426S and 111428S) have been etched and labelled with an incorrect length.
- Feb 27, 2008 · Not classified · Z-1446-2008: Certain QWIX Fixation Screws (Part numbers 111426s and 111428s) have been etched and labelled with an incorrect length.

## Indications for use
The STABILIZATION SCREW is indicated for fixation of bone fractures or for bone reconstruction. Examples include: Mono or Bi-cortical osteotomies in the foot or hand (including Hallux Valgus treatment) Fractures management in the foot and hand Fixation of bone fragments in long bones or small bones fractures Arthrodesis in hand, foot or ankle surgery The size of the chosen screw should be adapted to the specific indication.

Source page: https://510kreport.com/device/K050346
Methodology: https://510kreport.com/methodology