# K071639: Qwix Positioning Screw

- Pathway: 510(k) (Special)
- Applicant: Newdeal Sas
- Decided: Jul 9, 2007 after 24 days
- Product code: HWC (Screw, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3040
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K962823 (1996). 9 ancestors in all.
52 later devices descend from it; 5 cite it directly.
0 of 62 devices in its family (counting itself) have a Class I recall.

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

## Most influential descendants
- 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
- K170518: In2Bones Fracture and Correction System (2017), 15 descendants of its own
- K172617: Treace Medical Concepts (TMC) Compression Screw System (2017), 11 descendants of its own

## Recalls of this device
- Jul 21, 2016 · Class II · Z-2600-2016: Labeling on the Qwix Screw product states that it is a "compression screw" instead of a "positioning screw".

## Indications for use
The QWIX Positioning 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 or 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/K071639
Methodology: https://510kreport.com/methodology