510(k) · Cleared
Recalled · 2010Stabilization Screw
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
New Deal, S.A. · HWC Screw, Fixation, Bone
Cleared on Mar 17, 2005 as substantially equivalent to K011262 (New Deal, S.A., 2001) and 3 other predicates after a 34-day review. Its family tree reaches back 3 generations to 1996. 55 later devices descend from it. It has been recalled 4 times.
- Decided
- Mar 17, 2005
- Review
- 34 days
- Class
- Class II
- Product code
- HWC
- Recalls
- 4
- Predicates
- 4
Its longest line of descent runs back 3 generations to K962823 (1996). 8 ancestors in all. 55 later devices descend from it, 5 citing it directly.
- Root · 3 generations backK962823 Synthes Sterile 3.0 MM Cannulated Screw and Threaded WasherSynthes (Usa) · 1996
- 2 generations backK993762 I.CO.S ScrewNew Deal, S.A. · 2000
- 1 generation backK011821 Modification to the I.C.O.S ScrewNew Deal, S.A. · 2001
- This deviceK050346 Stabilization ScrewNew Deal, S.A. · 2005
- Descendant · cites it directly · 52 of its ownK071639 Qwix Positioning ScrewNewdeal Sas · 2007 · Recalled
- Descendant · cites it directly · 26 of its ownK091798 Merete Compression ScrewsMerete Medical GmbH · 2009
- Descendant · 2 generations on · 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
Showing 5 of 55 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 55 · See all- K071639Qwix Positioning ScrewNewdeal Sas · 2007 · cites it directly52descendants
- K091798Merete Compression ScrewsMerete Medical GmbH · 2009 · cites it directly26descendants
- K131722I.T.S. Extremity Fixation SystemsI.T.S. GmbH · 2013 · 2 generations on24descendants
- K131920Stabilization ScrewIn2bones Sas · 2014 · cites it directly18descendants
- K160174I.B.S. 2.0 Osteosynthesis screwIn2bones Sas · 2016 · 2 generations on17descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K962823 | Synthes Sterile 3.0 MM Cannulated Screw and Threaded Washer | Synthes (Usa) | 1996 | — |
| −2 | K993762 | I.CO.S Screw | New Deal, S.A. | 2000 | — |
| −1 | K011821 | Modification to the I.C.O.S Screw | New Deal, S.A. | 2001 | — |
| 0 (this device) | K050346 | Stabilization Screw | New Deal, S.A. | 2005 | — |
| +1 | K071639 | Qwix Positioning Screw | Newdeal Sas | 2007 | 1 |
| +1 | K091798 | Merete Compression Screws | Merete Medical GmbH | 2009 | — |
| +2 | 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 | — |
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 |
|---|---|---|
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 2 | 0 |
| 2015 | 3 | 0 |
| 2016 | 3 | 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? (4)
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 |
|---|---|---|---|
| * | K011262 | Modification to the Bold ScrewSummary page 2…o the predicate devices. J. Conclusion The 3.0 mm STABILIZATION SCREW is substantially equivalent to the predicate devices NewDeal Bold® Screw, K011262, DePuy Scarf Thread-Head Screw, K971070, and the 4.3 mm STABILIZATION SCREW is substantially equivalent to NewDeal… | 2001 |
| * | K971070 | Scarf Thread-Head (TM) Head ScrewSummary page 2…ing predicate devices: 3.0 mm STABILIZATION SCREW: Newdeal BOLD® screw KO1 1262 DePuy Scarf Thread-Head Screw K971070 4.3 mm STABILIZATION SCREW: Newdeal 4.0 mm I.CO.S.® Screw K011821 Synthes 4.5 mm Cannul… | 1997 |
| * | K011821 | Modification to the I.C.O.S ScrewSummary page 2…KO1 1262 DePuy Scarf Thread-Head Screw K971070 4.3 mm STABILIZATION SCREW: Newdeal 4.0 mm I.CO.S.® Screw K011821 Synthes 4.5 mm Cannulated Screw K963172 H. Comparison of Technological Characteristics The technol… | 2001 |
| * | K963172 | Synthes Sterile 4.5 MM Cannulated ScrewsSummary page 2…ead Screw K971070 4.3 mm STABILIZATION SCREW: Newdeal 4.0 mm I.CO.S.® Screw K011821 Synthes 4.5 mm Cannulated Screw K963172 H. Comparison of Technological Characteristics The technological characteristics of the STABILIZATION SCREW are the… | 1996 |
What descends from it? (55)
See all 555 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 |
|---|---|---|---|---|
| Feb 8, 2010 | Not classified | Z-1254-2010 | Labeling mix-ups | The screws were etched incorrectly as 32mm instead of the correct 34mm length. |
| Feb 8, 2010 | Not classified | Z-1253-2010 | Labeling mix-ups | The screws were etched incorrectly as 34mm instead of the correct 32mm. |
| Feb 27, 2008 | Not classified | Z-1445-2008 | Labeling mix-ups | 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 | Labeling mix-ups | Certain QWIX Fixation Screws (Part numbers 111426s and 111428s) have been etched and labelled with an incorrect length. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 9 years and passes through 2 companies; a new generation was cleared every 3.3 years on median.
- None of the 8 ancestors has a recall.
- Of its descendants, K071639 (Newdeal Sas, 2007) has gone furthest, with 52 descendants of its own.
- 3 other devices also cite its predicate K011262.
How does its category compare?
All HWC devicesHWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K050346 · printed Nov 6, 2026
Cite this page
510(k) Report. “K050346: Stabilization Screw.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K050346
Report an extraction error
Are you the manufacturer?
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