510(k) · Cleared
Recalled · Class II · 2024Stabilization Screw
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
In2bones Sas · HWC Screw, Fixation, Bone
Cleared on May 1, 2014 as substantially equivalent to K050346 (New Deal, S.A., 2005) and 4 other predicates after a 309-day review. Its family tree reaches back 5 generations to 1996. 18 later devices descend from it. It has been recalled 3 times.
- Decided
- May 1, 2014
- Review
- 309 days
- Class
- Class II
- Product code
- HWC
- Recalls
- 3
- Predicates
- 5
Its longest line of descent runs back 5 generations to K962823 (1996). 13 ancestors in all, the oldest K944330 (1995). 18 later devices descend from it, 5 citing it directly.
- Root · 5 generations backK962823 Synthes Sterile 3.0 MM Cannulated Screw and Threaded WasherSynthes (Usa) · 1996
- 4 generations backK993762 I.CO.S ScrewNew Deal, S.A. · 2000
- 3 generations backK011821 Modification to the I.C.O.S ScrewNew Deal, S.A. · 2001
- 2 generations backK050346 Stabilization ScrewNew Deal, S.A. · 2005 · Recalled
- 1 generation backK071639 Qwix Positioning ScrewNewdeal Sas · 2007 · Recalled
- This deviceK131920 Stabilization ScrewIn2bones Sas · 2014
- Descendant · cites it directly · 17 of its ownK160174 I.B.S. 2.0 Osteosynthesis screwIn2bones Sas · 2016
- Descendant · cites it directly · 15 of its ownK170518 In2Bones Fracture and Correction SystemIn2bones USA, LLC · 2017 · Recalled
- Descendant · 2 generations on · 7 of its ownK180377 Fracture and Correction SystemIn2bones USA, LLC · 2018
- Descendant · 2 generations on · 6 of its ownK191535 CoLink® Mini Plating SystemIn2bones USA, LLC · 2019
- Descendant · 3 generations on · 4 of its ownK212487 CoLink Vallux Plating SystemIn2bones USA, LLC · 2021
Showing 5 of 18 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 18 · See all- K160174I.B.S. 2.0 Osteosynthesis screwIn2bones Sas · 2016 · cites it directly17descendants
- K170518In2Bones Fracture and Correction SystemIn2bones USA, LLC · 2017 · cites it directly15descendants
- K180377Fracture and Correction SystemIn2bones USA, LLC · 2018 · 2 generations on7descendants
- K191535CoLink® Mini Plating SystemIn2bones USA, LLC · 2019 · 2 generations on6descendants
- K212487CoLink Vallux Plating SystemIn2bones USA, LLC · 2021 · 3 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K962823 | Synthes Sterile 3.0 MM Cannulated Screw and Threaded Washer | Synthes (Usa) | 1996 | — |
| −4 | K993762 | I.CO.S Screw | New Deal, S.A. | 2000 | — |
| −3 | K011821 | Modification to the I.C.O.S Screw | New Deal, S.A. | 2001 | — |
| −2 | K050346 | Stabilization Screw | New Deal, S.A. | 2005 | 4 |
| −1 | K071639 | Qwix Positioning Screw | Newdeal Sas | 2007 | 1 |
| 0 (this device) | K131920 | Stabilization Screw | In2bones Sas | 2014 | — |
| +1 | K160174 | I.B.S. 2.0 Osteosynthesis screw | In2bones Sas | 2016 | — |
| +1 | K170518 | In2Bones Fracture and Correction System | In2bones USA, LLC | 2017 | 1 |
| +2 | K180377 | Fracture and Correction System | In2bones USA, LLC | 2018 | — |
| +2 | K191535 | CoLink® Mini Plating System | In2bones USA, LLC | 2019 | — |
| +3 | K212487 | CoLink Vallux Plating System | In2bones USA, LLC | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1996 | 3 | 0 |
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2001 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 2020 | 3 | 0 |
| 2021 | 2 | 0 |
| 2023 | 2 | 0 |
| 2025 | 1 | 0 |
| 2026 | 4 | 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? (5)
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…e fields may be created and maintained. They are prescription devices. PredcateCompression design: PredcateNewdeal Stabilization screw (K050346) Devices: SBI Autofix (K052576) Synthes 7.0/7.3 cannulated screw (K96201 1) Ne… | 2005 |
| * | K052576 | Sbi AutofixSummary page 2…eated and maintained. They are prescription devices. PredcateCompression design: PredcateNewdeal Stabilization screw (K050346) Devices: SBI Autofix (K052576) Synthes 7.0/7.3 cannulated screw (K96201 1) Neutralization design:… | 2005 |
| * | K962011 | Synthes 7.0/7.3 MM Cannulated ScrewsSummary page 2…cateCompression design: PredcateNewdeal Stabilization screw (K050346) Devices: SBI Autofix (K052576) Synthes 7.0/7.3 cannulated screw (K96201 1) Neutralization design: Newdeal QWIX positioning screw (K071639)… | 1996 |
| * | K071639 | Qwix Positioning ScrewSummary page 2…52576) Synthes 7.0/7.3 cannulated screw (K96201 1) Neutralization design: Newdeal QWIX positioning screw (K071639) Acumned Acutrak screws (K944330) Synthes 7.0/7.3 cannulated screw (K962011I… | 2007 |
| * | K944330 | Acutrak Plus Fixation SystemSummary page 2…screw (K96201 1) Neutralization design: Newdeal QWIX positioning screw (K071639) Acumned Acutrak screws (K944330) Synthes 7.0/7.3 cannulated screw (K962011I… | 1995 |
What descends from it? (18)
See all 185 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 |
|---|---|---|---|---|
| Jan 26, 2024 | Class II | Z-1320-2024 | Process control | This Field Action is being conducted following the identification of a batch mix-up between I.B.S Compression screws diameter 6.5mm length 75mm and I.B.S Compression screws diameter 6.5mm length 80mm. The screws of the batches concerned… |
| Jan 26, 2024 | Class II | Z-1319-2024 | Process control | This Field Action is being conducted following the identification of a batch mix-up between I.B.S Compression screws diameter 6.5mm length 75mm and I.B.S Compression screws diameter 6.5mm length 80mm. The screws of the batches concerned… |
| Nov 18, 2015 | Class II | Z-0397-2016 | Nonconforming Material/Component | One batch of osteosynthesis screws were manufactured with the incorrect Torx imprint on the screw head. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 18 years and passes through 4 companies; a new generation was cleared every 3.3 years on median.
- 3 of the 13 ancestors have a recall of any class.
- Of its descendants, K160174 (In2bones Sas, 2016) has gone furthest, with 17 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. 2014, 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 I.B.S.M osteosynthesis screws are intended for:
- The fixation of arthrodeses, osteotomies or fractures of long or short bones of the upper and lower limbs
- Osteosyntheses requiring a mono or bicortical compression
The size of the chosen screw should be adapted to the specific indications.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K131920 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131920: 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/K131920
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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