510(k) · Cleared
Recalled · Class II · 2016Qwix Positioning Screw
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Newdeal Sas · HWC Screw, Fixation, Bone
Cleared on Jul 9, 2007 as substantially equivalent to K050346 (New Deal, S.A., 2005) after a 24-day review. Its family tree reaches back 4 generations to 1996. 52 later devices descend from it. It has been recalled once.
- Decided
- Jul 9, 2007
- Review
- 24 days
- Class
- Class II
- Product code
- HWC
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 4 generations to K962823 (1996). 9 ancestors in all. 52 later devices descend from it, 5 citing it directly.
- Root · 4 generations backK962823 Synthes Sterile 3.0 MM Cannulated Screw and Threaded WasherSynthes (Usa) · 1996
- 3 generations backK993762 I.CO.S ScrewNew Deal, S.A. · 2000
- 2 generations backK011821 Modification to the I.C.O.S ScrewNew Deal, S.A. · 2001
- 1 generation backK050346 Stabilization ScrewNew Deal, S.A. · 2005 · Recalled
- This deviceK071639 Qwix Positioning ScrewNewdeal Sas · 2007
- Descendant · cites it directly · 24 of its ownK131722 I.T.S. Extremity Fixation SystemsI.T.S. GmbH · 2013 · Recalled
- Descendant · cites it directly · 18 of its ownK131920 Stabilization ScrewIn2bones Sas · 2014 · Recalled
- Descendant · 2 generations on · 17 of its ownK160174 I.B.S. 2.0 Osteosynthesis screwIn2bones Sas · 2016
- Descendant · 2 generations on · 15 of its ownK170518 In2Bones Fracture and Correction SystemIn2bones USA, LLC · 2017 · Recalled
- Descendant · 2 generations on · 11 of its ownK172617 Treace Medical Concepts (TMC) Compression Screw SystemTreace Medical Concepts, Inc. · 2017
Showing 5 of 52 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 52 · See all- K131722I.T.S. Extremity Fixation SystemsI.T.S. GmbH · 2013 · cites it directly24descendants
- K131920Stabilization ScrewIn2bones Sas · 2014 · cites it directly18descendants
- K160174I.B.S. 2.0 Osteosynthesis screwIn2bones Sas · 2016 · 2 generations on17descendants
- K170518In2Bones Fracture and Correction SystemIn2bones USA, LLC · 2017 · 2 generations on15descendants
- K172617Treace Medical Concepts (TMC) Compression Screw SystemTreace Medical Concepts, Inc. · 2017 · 2 generations on11descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K962823 | Synthes Sterile 3.0 MM Cannulated Screw and Threaded Washer | Synthes (Usa) | 1996 | — |
| −3 | K993762 | I.CO.S Screw | New Deal, S.A. | 2000 | — |
| −2 | K011821 | Modification to the I.C.O.S Screw | New Deal, S.A. | 2001 | — |
| −1 | K050346 | Stabilization Screw | New Deal, S.A. | 2005 | 4 |
| 0 (this device) | K071639 | Qwix Positioning Screw | Newdeal Sas | 2007 | — |
| +1 | K131722 | I.T.S. Extremity Fixation Systems | I.T.S. GmbH | 2013 | 2 |
| +1 | K131920 | Stabilization Screw | In2bones Sas | 2014 | 3 |
| +2 | K160174 | I.B.S. 2.0 Osteosynthesis screw | In2bones Sas | 2016 | — |
| +2 | K170518 | In2Bones Fracture and Correction System | In2bones USA, LLC | 2017 | 1 |
| +2 | K172617 | Treace Medical Concepts (TMC) Compression Screw System | Treace Medical Concepts, Inc. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 2 | 0 |
| 2014 | 2 | 0 |
| 2015 | 3 | 0 |
| 2016 | 2 | 0 |
| 2017 | 6 | 0 |
| 2018 | 2 | 0 |
| 2019 | 3 | 0 |
| 2020 | 3 | 0 |
| 2021 | 5 | 0 |
| 2022 | 4 | 0 |
| 2023 | 4 | 0 |
| 2024 | 4 | 0 |
| 2025 | 3 | 0 |
| 2026 | 9 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in HWC? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new HWC device
- #1 K203011 Monster Screw Systemscore 22.2 · 14 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K050346 | Stabilization ScrewSummary page 2…pecific indication. G. Substantial Equivalence The QWIX® Positioning Screw is substantially equivalent to commercially marketed device, Stabilization Screw, K050346. H. Comparison of Technological Characteristics The modified device has the same fundamental scientific technology and in… | 2005 |
| † | K011821 | Modification to the I.C.O.S Screw | 2001 |
| † | K962011 | Synthes 7.0/7.3 MM Cannulated Screws | 1996 |
What descends from it? (52)
See all 525 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 21, 2016 | Class II | Z-2600-2016 | Labeling mix-ups | Labeling on the Qwix Screw product states that it is a "compression screw" instead of a "positioning screw". |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 11 years and passes through 3 companies; a new generation was cleared every 3.3 years on median.
- 1 of the 9 ancestors has a recall of any class.
- Of its descendants, K131722 (I.T.S. GmbH, 2013) has gone furthest, with 24 descendants of its own.
- 4 other devices also cite its predicate K050346.
How does its category compare?
All HWC devicesHWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · HWC
15in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HWC
111in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HWC
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HWC
2,893in 2025
MAUDE reports naming product code HWC, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 35 | 77 | 25 | 669 |
| 2008 | 33 | 76 | 33 | 660 |
| 2009 | 27 | 113 | 29 | 651 |
| 2010 | 23 | 110 | 7 | 765 |
| 2011 | 35 | 88 | 12 | 1,104 |
| 2012 | 20 | 99 | 30 | 3,339 |
| 2013 | 25 | 90 | 14 | 3,850 |
| 2014 | 31 | 88 | 2 | 2,549 |
| 2015 | 41 | 85 | 5 | 2,711 |
| 2016 | 26 | 131 | 4 | 2,285 |
| 2017 | 40 | 127 | 4 | 2,561 |
| 2018 | 20 | 106 | 1 | 3,662 |
| 2019 | 30 | 108 | 5 | 5,463 |
| 2020 | 28 | 75 | 4 | 4,820 |
| 2021 | 26 | 84 | 2 | 4,446 |
| 2022 | 26 | 167 | 13 | 3,934 |
| 2023 | 24 | 104 | 0 | 3,718 |
| 2024 | 17 | 90 | 0 | 3,575 |
| 2025 | 15 | 111 | 1 | 2,893 |
| 2026 | 21 | 125 | 2 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K071639 · printed Nov 4, 2026
Cite this page
510(k) Report. “K071639: Qwix Positioning Screw.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K071639
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026