510(k) · Cleared
ClearedFracture and Correction 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 Jun 20, 2018 as substantially equivalent to K170518 (In2bones USA, LLC, 2017) and 3 other predicates after a 128-day review. Its family tree reaches back 11 generations to 2000. 7 later devices descend from it.
- Decided
- Jun 20, 2018
- Review
- 128 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 11 generations to K000684 (2000). 94 ancestors in all, the oldest K792022 (1979). 7 later devices descend from it, 5 citing it directly.
- Root · 11 generations backK000684 Small Fragment Dynamic Compression Locking (DCL) SystemSynthes (Usa) · 2000 · Recalled
- 7 generations between
- 3 generations backK112437 Arthrex Fracture SystemArthrex, Inc. · 2011
- 2 generations backK123241 Arthrex Fracture PlatesArthrex, Inc. · 2013
- 1 generation backK170518 In2Bones Fracture and Correction SystemIn2bones USA, LLC · 2017 · Recalled
- This deviceK180377 Fracture and Correction SystemIn2bones USA, LLC · 2018
- Descendant · cites it directly · 1 of its ownK231236 IBS-B MIS Beveled Screw SystemIn2bones USA, LLC · 2023
- Descendant · cites it directly · 1 of its ownK202817 GEO Bone Screw SystemGramercy Extremity Orthopedics, LLC · 2020
- Descendant · 2 generations on · 0 of its ownK254280 F.A.S.T ScrewSteps Ortho · 2026
- Descendant · cites it directly · 0 of its ownK261154 CoLink® & CoLag® Non-Sterile ScrewsIn2Bones USA, LLC · 2026
- Descendant · 2 generations on · 0 of its ownK230946 Accelerate Compression Screw System-Small Product Code ACC-S…Trax Surgical · 2023
Show all 11 generations
- Root · 11 generations backK000684 Small Fragment Dynamic Compression Locking (DCL) SystemSynthes (Usa) · 2000 · Recalled
- 10 generations backK011335 Synths One-Third Tubular DCL PlateSynthes (Usa) · 2001 · Recalled
- 9 generations backK012655 Congruent Bone Plate SystemAcu Med, Inc. · 2001 · Recalled
- 8 generations backK021626 Hallu PlatesNew Deal, S.A. · 2002
- 7 generations backK040907 Arthrex Small Fragment Plates and ScrewsArthrex, Inc. · 2004
- 6 generations backK052614 Low Profile Plate and Screw SystemArthrex, Inc. · 2005
- 5 generations backK103705 Low Profile ScrewsArthrex, Inc. · 2011
- 4 generations backK111253 Arthrex Distal Extremity Plate SystemArthrex, Inc. · 2011
- 3 generations backK112437 Arthrex Fracture SystemArthrex, Inc. · 2011
- 2 generations backK123241 Arthrex Fracture PlatesArthrex, Inc. · 2013
- 1 generation backK170518 In2Bones Fracture and Correction SystemIn2bones USA, LLC · 2017 · Recalled
- This deviceK180377 Fracture and Correction SystemIn2bones USA, LLC · 2018
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K231236IBS-B MIS Beveled Screw SystemIn2bones USA, LLC · 2023 · cites it directly1descendant
- K202817GEO Bone Screw SystemGramercy Extremity Orthopedics, LLC · 2020 · cites it directly1descendant
- K254280F.A.S.T ScrewSteps Ortho · 2026 · 2 generations on0descendants
- K261154CoLink® & CoLag® Non-Sterile ScrewsIn2Bones USA, LLC · 2026 · cites it directly0descendants
- K230946Accelerate Compression Screw System-Small Product Code ACC-S; Accelerate Compression…Trax Surgical · 2023 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K000684 | Small Fragment Dynamic Compression Locking (DCL) System | Synthes (Usa) | 2000 | 1 |
| −10 | K011335 | Synths One-Third Tubular DCL Plate | Synthes (Usa) | 2001 | 2 |
| −9 | K012655 | Congruent Bone Plate System | Acu Med, Inc. | 2001 | 16 |
| −8 | K021626 | Hallu Plates | New Deal, S.A. | 2002 | — |
| −7 | K040907 | Arthrex Small Fragment Plates and Screws | Arthrex, Inc. | 2004 | — |
| −6 | K052614 | Low Profile Plate and Screw System | Arthrex, Inc. | 2005 | — |
| −5 | K103705 | Low Profile Screws | Arthrex, Inc. | 2011 | — |
| −4 | K111253 | Arthrex Distal Extremity Plate System | Arthrex, Inc. | 2011 | — |
| −3 | K112437 | Arthrex Fracture System | Arthrex, Inc. | 2011 | — |
| −2 | K123241 | Arthrex Fracture Plates | Arthrex, Inc. | 2013 | — |
| −1 | K170518 | In2Bones Fracture and Correction System | In2bones USA, LLC | 2017 | 1 |
| 0 (this device) | K180377 | Fracture and Correction System | In2bones USA, LLC | 2018 | — |
| +1 | K231236 | IBS-B MIS Beveled Screw System | In2bones USA, LLC | 2023 | — |
| +1 | K202817 | GEO Bone Screw System | Gramercy Extremity Orthopedics, LLC | 2020 | — |
| +2 | K254280 | F.A.S.T Screw | Steps Ortho | 2026 | — |
| +1 | K261154 | CoLink® & CoLag® Non-Sterile Screws | In2Bones USA, LLC | 2026 | — |
| +2 | K230946 | Accelerate Compression Screw System-Small Product Code ACC-S; Accelerate… | Trax Surgical | 2023 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2023 | 2 | 0 |
| 2026 | 2 | 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 |
|---|---|---|---|
| * | K170518 | In2Bones Fracture and Correction SystemSummary page 5…e demonstrated to be substantially equivalent to the following systems previously cleared by the FDA: Primary Predicate • K170518 – In2Bones Fracture and Correction System Additional Predicates • K052576 – AutoFix Screws… | 2017 |
| * | K052576 | Sbi AutofixSummary page 5…the FDA: Primary Predicate • K170518 – In2Bones Fracture and Correction System Additional Predicates • K052576 – AutoFix Screws • K160174 – IBS 2.0mm Screws • K143460 – Wright Medical Cannulated Screw Sys… | 2005 |
| * | K160174 | I.B.S. 2.0 Osteosynthesis screwSummary page 5…• K170518 – In2Bones Fracture and Correction System Additional Predicates • K052576 – AutoFix Screws • K160174 – IBS 2.0mm Screws • K143460 – Wright Medical Cannulated Screw System See below for a comparison… | 2016 |
| * | K143460 | Cannulated Screw SystemSummary page 5…and Correction System Additional Predicates • K052576 – AutoFix Screws • K160174 – IBS 2.0mm Screws • K143460 – Wright Medical Cannulated Screw System See below for a comparison table of the subject and predicate devices.… | 2015 |
What descends from it? (7)
5 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K231236 | IBS-B MIS Beveled Screw System | 2023 | 1 |
| K202817 | GEO Bone Screw System | 2020 | 1 |
| K261154 | CoLink® & CoLag® Non-Sterile Screws | 2026 | 0 |
| K193543 | CoLink Plating System, Fracture and Correction System, CoLink Mini Plating System… | 2020 | 0 |
| K190385 | CoLink Plating System, Fracture and Correction System, RTS Implant System, NeoSpan… | 2019 | 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 18 years and passes through 5 companies; a new generation was cleared every 1.2 years on median.
- 17 of the 94 ancestors have a recall of any class.
- Of its descendants, K231236 (In2bones USA, LLC, 2023) has gone furthest, with 1 descendant of its own.
- 5 other devices also cite its predicate K170518.
How does its category compare?
All HWC devicesHWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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 USA LLC, Fracture and Correction System plates and screws are intended to treat fractures, fusions, osteotomies and non-unions of the 5th metatarsal.
The Fracture and Correction System lag screws are intended to be used as stand-alone bone screws, or in a plate-screw system for internal bone fixation for bone fractures, fusions, osteotomies and non-unions of various bones, including humerus, radius, ulna, tibia, calcaneus, fibula, and small bones (metacarpals, metatarsals, and phalanges).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K180377 · printed Nov 6, 2026
Cite this page
510(k) Report. “K180377: Fracture and Correction System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K180377
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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