510(k) · Cleared
ClearedIBS-B MIS Beveled Screw System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
In2bones USA, LLC · HWC Screw, Fixation, Bone
Cleared on Jul 27, 2023 as substantially equivalent to K131920 (In2bones Sas, 2014) and 3 other predicates after a 90-day review. Its family tree reaches back 12 generations to 2000. 1 later device descends from it.
- Decided
- Jul 27, 2023
- Review
- 90 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 12 generations to K000684 (2000). 96 ancestors in all, the oldest K792022 (1979). 1 later device descends from it, 1 citing it directly.
- Root · 12 generations backK000684 Small Fragment Dynamic Compression Locking (DCL) SystemSynthes (Usa) · 2000 · Recalled
- 8 generations between
- 3 generations backK123241 Arthrex Fracture PlatesArthrex, Inc. · 2013
- 2 generations backK170518 In2Bones Fracture and Correction SystemIn2bones USA, LLC · 2017 · Recalled
- 1 generation backK180377 Fracture and Correction SystemIn2bones USA, LLC · 2018
- This deviceK231236 IBS-B MIS Beveled Screw SystemIn2bones USA, LLC · 2023
- Descendant · cites it directly · 0 of its ownK254280 F.A.S.T ScrewSteps Ortho · 2026
Show all 12 generations
- Root · 12 generations backK000684 Small Fragment Dynamic Compression Locking (DCL) SystemSynthes (Usa) · 2000 · Recalled
- 11 generations backK011335 Synths One-Third Tubular DCL PlateSynthes (Usa) · 2001 · Recalled
- 10 generations backK012655 Congruent Bone Plate SystemAcu Med, Inc. · 2001 · Recalled
- 9 generations backK021626 Hallu PlatesNew Deal, S.A. · 2002
- 8 generations backK040907 Arthrex Small Fragment Plates and ScrewsArthrex, Inc. · 2004
- 7 generations backK052614 Low Profile Plate and Screw SystemArthrex, Inc. · 2005
- 6 generations backK103705 Low Profile ScrewsArthrex, Inc. · 2011
- 5 generations backK111253 Arthrex Distal Extremity Plate SystemArthrex, Inc. · 2011
- 4 generations backK112437 Arthrex Fracture SystemArthrex, Inc. · 2011
- 3 generations backK123241 Arthrex Fracture PlatesArthrex, Inc. · 2013
- 2 generations backK170518 In2Bones Fracture and Correction SystemIn2bones USA, LLC · 2017 · Recalled
- 1 generation backK180377 Fracture and Correction SystemIn2bones USA, LLC · 2018
- This deviceK231236 IBS-B MIS Beveled Screw SystemIn2bones USA, LLC · 2023
Most influential descendants
Showing 1 of 1 · See all- K254280F.A.S.T ScrewSteps Ortho · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K000684 | Small Fragment Dynamic Compression Locking (DCL) System | Synthes (Usa) | 2000 | 1 |
| −11 | K011335 | Synths One-Third Tubular DCL Plate | Synthes (Usa) | 2001 | 2 |
| −10 | K012655 | Congruent Bone Plate System | Acu Med, Inc. | 2001 | 16 |
| −9 | K021626 | Hallu Plates | New Deal, S.A. | 2002 | — |
| −8 | K040907 | Arthrex Small Fragment Plates and Screws | Arthrex, Inc. | 2004 | — |
| −7 | K052614 | Low Profile Plate and Screw System | Arthrex, Inc. | 2005 | — |
| −6 | K103705 | Low Profile Screws | Arthrex, Inc. | 2011 | — |
| −5 | K111253 | Arthrex Distal Extremity Plate System | Arthrex, Inc. | 2011 | — |
| −4 | K112437 | Arthrex Fracture System | Arthrex, Inc. | 2011 | — |
| −3 | K123241 | Arthrex Fracture Plates | Arthrex, Inc. | 2013 | — |
| −2 | K170518 | In2Bones Fracture and Correction System | In2bones USA, LLC | 2017 | 1 |
| −1 | K180377 | Fracture and Correction System | In2bones USA, LLC | 2018 | — |
| 0 (this device) | K231236 | IBS-B MIS Beveled Screw System | In2bones USA, LLC | 2023 | — |
| +1 | K254280 | F.A.S.T Screw | Steps Ortho | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 2 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 3 | 0 |
| 1995 | 6 | 0 |
| 1996 | 13 | 0 |
| 1997 | 5 | 0 |
| 1998 | 4 | 0 |
| 1999 | 6 | 0 |
| 2000 | 2 | 0 |
| 2001 | 10 | 0 |
| 2002 | 5 | 0 |
| 2003 | 3 | 0 |
| 2004 | 3 | 0 |
| 2005 | 6 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 1 | 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 |
|---|---|---|---|
| * | K131920 | Stabilization ScrewSummary page 4…ial Equivalence: The subject components were demonstrated to be substantially equivalent to the following systems previously cleared by the FDA: Primary Predicate • K131920 – In2Bones SAS Osteosynthesis Screws… | 2014 |
| * | K162353 | MICATM Screw SystemSummary page 5…K231236 Page 2 of 2 Additional Predicates • K162353 – MICA Screws • K170518 & K180377 – In2Bones Fracture and Correction System The subject IBS-B MIS Beveled Screw System screws… | 2017 |
| * | K170518 | In2Bones Fracture and Correction SystemSummary page 5…6 Page 2 of 2 Additional Predicates • K162353 – MICA Screws • K170518 & K180377 – In2Bones Fracture and Correction System The subject IBS-B MIS Beveled Screw System screws are similar geometry to th… | 2017 |
| * | K180377 | Fracture and Correction SystemSummary page 5…Page 2 of 2 Additional Predicates • K162353 – MICA Screws • K170518 & K180377 – In2Bones Fracture and Correction System The subject IBS-B MIS Beveled Screw System screws are similar geometry to the previous… | 2018 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K254280 | F.A.S.T Screw | 2026 | 0 |
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 23 years and passes through 5 companies; a new generation was cleared every 1.2 years on median.
- 17 of the 96 ancestors have a recall of any class.
- Of its descendants, K254280 (Steps Ortho, 2026) has gone furthest, with 0 descendants of its own.
- 4 other devices also cite its predicate K131920.
How does its category compare?
All HWC devicesHWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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 In2Bones IBS-B MIS Beveled Screw System is indicated for the fixation of arthrodesis, osteotomies or fractures of long or short bones of the upper and lower limbs appropriate for the size of the device.
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/K231236 · printed Nov 6, 2026
Cite this page
510(k) Report. “K231236: IBS-B MIS Beveled Screw System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K231236
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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