510(k) · Cleared
Recalled · Class II · 2026In2Bones Fracture and Correction System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
In2bones USA, LLC · HRS Plate, Fixation, Bone
Cleared on Jul 14, 2017 as substantially equivalent to K123241 (Arthrex, Inc., 2013) and 3 other predicates after a 143-day review. Its family tree reaches back 10 generations to 2000. 15 later devices descend from it. It has been recalled once.
- Decided
- Jul 14, 2017
- Review
- 143 days
- Class
- Class II
- Product code
- HRS
- Recalls
- 1
- Predicates
- 4
Its longest line of descent runs back 10 generations to K000684 (2000). 89 ancestors in all, the oldest K792022 (1979). 15 later devices descend from it, 6 citing it directly.
- Root · 10 generations backK000684 Small Fragment Dynamic Compression Locking (DCL) SystemSynthes (Usa) · 2000 · Recalled
- 6 generations between
- 3 generations backK111253 Arthrex Distal Extremity Plate SystemArthrex, Inc. · 2011
- 2 generations backK112437 Arthrex Fracture SystemArthrex, Inc. · 2011
- 1 generation backK123241 Arthrex Fracture PlatesArthrex, Inc. · 2013
- This deviceK170518 In2Bones Fracture and Correction SystemIn2bones USA, LLC · 2017
- Descendant · cites it directly · 7 of its ownK180377 Fracture and Correction SystemIn2bones USA, LLC · 2018
- Descendant · cites it directly · 6 of its ownK191535 CoLink® Mini Plating SystemIn2bones USA, LLC · 2019
- Descendant · 2 generations on · 4 of its ownK212487 CoLink Vallux Plating SystemIn2bones USA, LLC · 2021
- Descendant · 3 generations on · 3 of its ownK211650 The Radian MIS Bunion SystemNvision Biomedical Technologies, Inc. · 2021
- Descendant · 4 generations on · 1 of its ownK253718 enHAnce PEEK Bunion SystemNvision Biomedical Technologies, Inc. · 2026
Show all 10 generations
- Root · 10 generations backK000684 Small Fragment Dynamic Compression Locking (DCL) SystemSynthes (Usa) · 2000 · Recalled
- 9 generations backK011335 Synths One-Third Tubular DCL PlateSynthes (Usa) · 2001 · Recalled
- 8 generations backK012655 Congruent Bone Plate SystemAcu Med, Inc. · 2001 · Recalled
- 7 generations backK021626 Hallu PlatesNew Deal, S.A. · 2002
- 6 generations backK040907 Arthrex Small Fragment Plates and ScrewsArthrex, Inc. · 2004
- 5 generations backK052614 Low Profile Plate and Screw SystemArthrex, Inc. · 2005
- 4 generations backK103705 Low Profile ScrewsArthrex, Inc. · 2011
- 3 generations backK111253 Arthrex Distal Extremity Plate SystemArthrex, Inc. · 2011
- 2 generations backK112437 Arthrex Fracture SystemArthrex, Inc. · 2011
- 1 generation backK123241 Arthrex Fracture PlatesArthrex, Inc. · 2013
- This deviceK170518 In2Bones Fracture and Correction SystemIn2bones USA, LLC · 2017
Showing 5 of 15 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 15 · See all- K180377Fracture and Correction SystemIn2bones USA, LLC · 2018 · cites it directly7descendants
- K191535CoLink® Mini Plating SystemIn2bones USA, LLC · 2019 · cites it directly6descendants
- K212487CoLink Vallux Plating SystemIn2bones USA, LLC · 2021 · 2 generations on4descendants
- K211650The Radian MIS Bunion SystemNvision Biomedical Technologies, Inc. · 2021 · 3 generations on3descendants
- K253718enHAnce PEEK Bunion SystemNvision Biomedical Technologies, Inc. · 2026 · 4 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K000684 | Small Fragment Dynamic Compression Locking (DCL) System | Synthes (Usa) | 2000 | 1 |
| −9 | K011335 | Synths One-Third Tubular DCL Plate | Synthes (Usa) | 2001 | 2 |
| −8 | K012655 | Congruent Bone Plate System | Acu Med, Inc. | 2001 | 16 |
| −7 | K021626 | Hallu Plates | New Deal, S.A. | 2002 | — |
| −6 | K040907 | Arthrex Small Fragment Plates and Screws | Arthrex, Inc. | 2004 | — |
| −5 | K052614 | Low Profile Plate and Screw System | Arthrex, Inc. | 2005 | — |
| −4 | K103705 | Low Profile Screws | Arthrex, Inc. | 2011 | — |
| −3 | K111253 | Arthrex Distal Extremity Plate System | Arthrex, Inc. | 2011 | — |
| −2 | K112437 | Arthrex Fracture System | Arthrex, Inc. | 2011 | — |
| −1 | K123241 | Arthrex Fracture Plates | Arthrex, Inc. | 2013 | — |
| 0 (this device) | K170518 | In2Bones Fracture and Correction System | In2bones USA, LLC | 2017 | — |
| +1 | K180377 | Fracture and Correction System | In2bones USA, LLC | 2018 | — |
| +1 | K191535 | CoLink® Mini Plating System | In2bones USA, LLC | 2019 | — |
| +2 | K212487 | CoLink Vallux Plating System | In2bones USA, LLC | 2021 | — |
| +3 | K211650 | The Radian MIS Bunion System | Nvision Biomedical Technologies, Inc. | 2021 | — |
| +4 | K253718 | enHAnce PEEK Bunion System | Nvision Biomedical Technologies, Inc. | 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 | 5 | 0 |
| 2000 | 2 | 0 |
| 2001 | 10 | 0 |
| 2002 | 5 | 0 |
| 2003 | 3 | 0 |
| 2004 | 2 | 0 |
| 2005 | 6 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 HRS? 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 HRS device
- #1 K222465 Tyber Medical Anatomical Plating Systemscore 27.5 · 16 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 |
|---|---|---|---|
| * | K123241 | Arthrex Fracture PlatesSummary page 5…Class II Product Code: HRS, HWC, HTN Review Panel: Orthopedic III. Predicate Device Predicate Device: K123241 Arthrex Fracture Plates K983495 Syntec Taichung Non-Sterile Bone Plate and Screw… | 2013 |
| * | K983495 | Syntec-Taichung Non-Sterile Bone Plate and Screw Implants, Model#'S 222020-248120…Summary page 5…eview Panel: Orthopedic III. Predicate Device Predicate Device: K123241 Arthrex Fracture Plates K983495 Syntec Taichung Non-Sterile Bone Plate and Screw Implants K1319… | 1998 |
| * | K131920 | Stabilization ScrewSummary page 5…ates K983495 Syntec Taichung Non-Sterile Bone Plate and Screw Implants K131920 In2Bones SAS I.B.S. Osteosynthesis Screw K160174 In2Bones SAS I.B.S. 2.0 Osteosynthesis Screw… | 2014 |
| * | K160174 | I.B.S. 2.0 Osteosynthesis screwSummary page 5…te and Screw Implants K131920 In2Bones SAS I.B.S. Osteosynthesis Screw K160174 In2Bones SAS I.B.S. 2.0 Osteosynthesis Screw IV. Device Description The In2Bones Fracture and Correction System is a sys… | 2016 |
What descends from it? (15)
See all 156 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K180377 | Fracture and Correction System | 2018 | 7 |
| K191535 | CoLink® Mini Plating System | 2019 | 6 |
| K231236 | IBS-B MIS Beveled Screw System | 2023 | 1 |
| K201149 | CoLink Plating System | 2020 | 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 9, 2026 | Class II | Z-0157-2027 | Error in labeling | Due to labeling error, bone screws specified as fully threaded, are actually partially threaded screws. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 17 years and passes through 5 companies; a new generation was cleared every 1.2 years on median.
- 16 of the 89 ancestors have a recall of any class.
- Of its descendants, K180377 (In2bones USA, LLC, 2018) has gone furthest, with 7 descendants of its own.
- 13 other devices also cite its predicate K123241.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · HRS
54in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HRS
90in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HRS
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HRS
2,306in 2025
MAUDE reports naming product code HRS, 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 | 63 | 2 | 339 |
| 2008 | 35 | 87 | 11 | 311 |
| 2009 | 47 | 85 | 3 | 435 |
| 2010 | 49 | 100 | 16 | 491 |
| 2011 | 43 | 88 | 5 | 773 |
| 2012 | 59 | 106 | 4 | 1,663 |
| 2013 | 56 | 89 | 11 | 2,643 |
| 2014 | 76 | 57 | 0 | 2,413 |
| 2015 | 56 | 97 | 7 | 3,095 |
| 2016 | 44 | 109 | 5 | 2,276 |
| 2017 | 57 | 122 | 3 | 2,220 |
| 2018 | 40 | 116 | 2 | 2,663 |
| 2019 | 46 | 89 | 25 | 3,359 |
| 2020 | 48 | 88 | 1 | 2,790 |
| 2021 | 40 | 87 | 9 | 2,442 |
| 2022 | 47 | 144 | 3 | 1,700 |
| 2023 | 40 | 120 | 1 | 2,049 |
| 2024 | 54 | 96 | 0 | 1,849 |
| 2025 | 54 | 90 | 1 | 2,306 |
| 2026 | 51 | 82 | 3 | — |
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/K170518 · printed Nov 6, 2026
Cite this page
510(k) Report. “K170518: In2Bones 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/K170518
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