510(k) · Cleared
ClearedI.B.S. 2.0 Osteosynthesis 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 Oct 6, 2016 as substantially equivalent to K014154 (Vilex, Inc., 2002) and 2 other predicates after a 253-day review. Its family tree reaches back 6 generations to 1996. 17 later devices descend from it.
- Decided
- Oct 6, 2016
- Review
- 253 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 6 generations to K962823 (1996). 15 ancestors in all, the oldest K944330 (1995). 17 later devices descend from it, 4 citing it directly.
- Root · 6 generations backK962823 Synthes Sterile 3.0 MM Cannulated Screw and Threaded WasherSynthes (Usa) · 1996
- 5 generations backK993762 I.CO.S ScrewNew Deal, S.A. · 2000
- 4 generations backK011821 Modification to the I.C.O.S ScrewNew Deal, S.A. · 2001
- 3 generations backK050346 Stabilization ScrewNew Deal, S.A. · 2005 · Recalled
- 2 generations backK071639 Qwix Positioning ScrewNewdeal Sas · 2007 · Recalled
- 1 generation backK131920 Stabilization ScrewIn2bones Sas · 2014 · Recalled
- This deviceK160174 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 · cites it directly · 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
- Descendant · 4 generations on · 3 of its ownK211650 The Radian MIS Bunion SystemNvision Biomedical Technologies, Inc. · 2021
Showing 5 of 17 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 17 · See all- K170518In2Bones Fracture and Correction SystemIn2bones USA, LLC · 2017 · cites it directly15descendants
- K180377Fracture and Correction SystemIn2bones USA, LLC · 2018 · cites it directly7descendants
- K191535CoLink® Mini Plating SystemIn2bones USA, LLC · 2019 · 2 generations on6descendants
- K212487CoLink Vallux Plating SystemIn2bones USA, LLC · 2021 · 3 generations on4descendants
- K211650The Radian MIS Bunion SystemNvision Biomedical Technologies, Inc. · 2021 · 4 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K962823 | Synthes Sterile 3.0 MM Cannulated Screw and Threaded Washer | Synthes (Usa) | 1996 | — |
| −5 | K993762 | I.CO.S Screw | New Deal, S.A. | 2000 | — |
| −4 | K011821 | Modification to the I.C.O.S Screw | New Deal, S.A. | 2001 | — |
| −3 | K050346 | Stabilization Screw | New Deal, S.A. | 2005 | 4 |
| −2 | K071639 | Qwix Positioning Screw | Newdeal Sas | 2007 | 1 |
| −1 | K131920 | Stabilization Screw | In2bones Sas | 2014 | 3 |
| 0 (this device) | K160174 | I.B.S. 2.0 Osteosynthesis screw | In2bones Sas | 2016 | — |
| +1 | K170518 | In2Bones Fracture and Correction System | In2bones USA, LLC | 2017 | 1 |
| +1 | 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 | — |
| +4 | K211650 | The Radian MIS Bunion System | Nvision Biomedical Technologies, Inc. | 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 |
| 2002 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (3)
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 |
|---|---|---|---|
| * | K014154 | Vilex/Duval/Orthex Cannulated Bone Screw DB1 Thread, Model F25-XX-09; Vilex Solid Bone…Summary page 5…atient surgery center where sterile field may be created and maintained. Predicate Devices Vilex Cannulated Bone Screw Double Thread (K014154) I.B.S.™ osteosynthesis screw (K131920) SBI AUTOFIX screw (K052576) Indicat… | 2002 |
| * | K131920 | Stabilization ScrewSummary page 5…ication Device Description The I.B.S™ 2.0 Osteosynthesis screw is a line extension of the existing compression screw line cleared in K131920 I.B.S™ Osteosynthesis screw. The I.B.S.™ 2.0 Osteosynthesis screws are can… | 2014 |
| * | K052576 | Sbi AutofixSummary page 5…Vilex Cannulated Bone Screw Double Thread (K014154) I.B.S.™ osteosynthesis screw (K131920) SBI AUTOFIX screw (K052576) Indications for use: The I.B.S.™ 2.0 Osteosynthesis screws are intended for: - The fixation of… | 2005 |
What descends from it? (17)
See all 174 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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 20 years and passes through 4 companies; a new generation was cleared every 3.3 years on median.
- 4 of the 15 ancestors have a recall of any class.
- Of its descendants, K170518 (In2bones USA, LLC, 2017) has gone furthest, with 15 descendants of its own.
- 15 other devices also cite its predicate K014154.
How does its category compare?
All HWC devicesHWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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 1.B.S.™ 2.0 Osteosynthesis screws are intended for:
- The fixation of arthrodeses, osteotomies or fractures of small bones of the upper and lower limbs
- Osteosynthesis requiring mono or bicortical compression
The size of the chosen screw should be adapted to the specific indications.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K160174 · printed Nov 4, 2026
Cite this page
510(k) Report. “K160174: I.B.S. 2.0 Osteosynthesis screw.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K160174
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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