510(k) · Cleared
ClearedCoLink™ Afx Plating 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 Jun 15, 2018 as substantially equivalent to K163293 (In2bones USA, LLC, 2017) and 4 other predicates after a 49-day review. Its family tree reaches back 15 generations to 1996. 14 later devices descend from it.
- Decided
- Jun 15, 2018
- Review
- 49 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 15 generations to K962616 (1996). 121 ancestors in all, the oldest K792022 (1979). 14 later devices descend from it, 9 citing it directly.
- Root · 15 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
- 11 generations between
- 3 generations backK120854 Synthes VA LCP Ankle Trauma SystemSynthes USA · 2012
- 2 generations backK143385 Acumed Ankle Plating SystemAcumed, LLC · 2015
- 1 generation backK151886 Acumed Ankle and Small Fragment Base Set UpdateAcumed, LLC · 2015
- This deviceK181113 CoLink™ Afx Plating SystemIn2bones USA, LLC · 2018
- Descendant · cites it directly · 6 of its ownK191535 CoLink® Mini Plating SystemIn2bones USA, LLC · 2019
- Descendant · cites it directly · 4 of its ownK212487 CoLink Vallux Plating SystemIn2bones USA, LLC · 2021
- Descendant · 2 generations on · 3 of its ownK211650 The Radian MIS Bunion SystemNvision Biomedical Technologies, Inc. · 2021
- Descendant · 3 generations on · 1 of its ownK253718 enHAnce PEEK Bunion SystemNvision Biomedical Technologies, Inc. · 2026
- Descendant · cites it directly · 1 of its ownK213069 CoLink NeoFuse Plating SystemIn2bones USA, LLC · 2021
Show all 15 generations
- Root · 15 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
- 14 generations backK982732 Synthes (Usa) Distal Radius Plate System (DRPS)Synthes · 1998
- 13 generations backK023007 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2002
- 12 generations backK030198 Hand Innovations, Inc. Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
- 11 generations backK032705 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
- 10 generations backK050932 Distal Volar Radius Anatomical Plate SystemHand Innovations, Inc. · 2005 · Recalled
- 9 generations backK051735 Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper…Smith & Nephew, Inc. · 2005
- 8 generations backK071563 Peri-Loc Periarticular Locked Plating SystemSmith & Nephew, Inc. · 2007
- 7 generations backK090675 Smith & Nephew, Inc. VLP Foot Plating, Screw System and AccessoriesSmith & Nephew, Inc. · 2009
- 6 generations backK100776 Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot SystemSynthes (Usa) · 2010
- 5 generations backK120070 Synthes Variable Angle LCP Elbow SystemSynthes USA · 2012 · Recalled
- 4 generations backK120717 Synthes Variable Angle LCP Elbow System (Medical and Posterolateral…Synthes USA · 2012
- 3 generations backK120854 Synthes VA LCP Ankle Trauma SystemSynthes USA · 2012
- 2 generations backK143385 Acumed Ankle Plating SystemAcumed, LLC · 2015
- 1 generation backK151886 Acumed Ankle and Small Fragment Base Set UpdateAcumed, LLC · 2015
- This deviceK181113 CoLink™ Afx Plating SystemIn2bones USA, LLC · 2018
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K191535CoLink® Mini Plating SystemIn2bones USA, LLC · 2019 · cites it directly6descendants
- K212487CoLink Vallux Plating SystemIn2bones USA, LLC · 2021 · cites it directly4descendants
- K211650The Radian MIS Bunion SystemNvision Biomedical Technologies, Inc. · 2021 · 2 generations on3descendants
- K253718enHAnce PEEK Bunion SystemNvision Biomedical Technologies, Inc. · 2026 · 3 generations on1descendant
- K213069CoLink NeoFuse Plating SystemIn2bones USA, LLC · 2021 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −15 | K962616 | Synthes Dorsal Distal Radius Plate (DDRP) System | Synthes (Usa) | 1996 | — |
| −14 | K982732 | Synthes (Usa) Distal Radius Plate System (DRPS) | Synthes | 1998 | — |
| −13 | K023007 | Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2002 | — |
| −12 | K030198 | Hand Innovations, Inc. Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2003 | — |
| −11 | K032705 | Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2003 | — |
| −10 | K050932 | Distal Volar Radius Anatomical Plate System | Hand Innovations, Inc. | 2005 | 1 |
| −9 | K051735 | Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper Extremity | Smith & Nephew, Inc. | 2005 | — |
| −8 | K071563 | Peri-Loc Periarticular Locked Plating System | Smith & Nephew, Inc. | 2007 | — |
| −7 | K090675 | Smith & Nephew, Inc. VLP Foot Plating, Screw System and Accessories | Smith & Nephew, Inc. | 2009 | — |
| −6 | K100776 | Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot System | Synthes (Usa) | 2010 | — |
| −5 | K120070 | Synthes Variable Angle LCP Elbow System | Synthes USA | 2012 | 1 |
| −4 | K120717 | Synthes Variable Angle LCP Elbow System (Medical and Posterolateral Distal… | Synthes USA | 2012 | — |
| −3 | K120854 | Synthes VA LCP Ankle Trauma System | Synthes USA | 2012 | — |
| −2 | K143385 | Acumed Ankle Plating System | Acumed, LLC | 2015 | — |
| −1 | K151886 | Acumed Ankle and Small Fragment Base Set Update | Acumed, LLC | 2015 | — |
| 0 (this device) | K181113 | CoLink™ Afx Plating System | In2bones USA, LLC | 2018 | — |
| +1 | K191535 | CoLink® Mini Plating System | In2bones USA, LLC | 2019 | — |
| +1 | K212487 | CoLink Vallux Plating System | In2bones USA, LLC | 2021 | — |
| +2 | K211650 | The Radian MIS Bunion System | Nvision Biomedical Technologies, Inc. | 2021 | — |
| +3 | K253718 | enHAnce PEEK Bunion System | Nvision Biomedical Technologies, Inc. | 2026 | — |
| +1 | K213069 | CoLink NeoFuse Plating System | In2bones USA, LLC | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 2 | 0 |
| 1994 | 4 | 0 |
| 1995 | 2 | 0 |
| 1996 | 7 | 0 |
| 1997 | 1 | 0 |
| 1998 | 4 | 0 |
| 1999 | 3 | 0 |
| 2000 | 10 | 0 |
| 2001 | 9 | 0 |
| 2002 | 3 | 0 |
| 2003 | 5 | 0 |
| 2004 | 7 | 0 |
| 2005 | 6 | 0 |
| 2006 | 7 | 0 |
| 2007 | 3 | 0 |
| 2008 | 8 | 0 |
| 2009 | 5 | 0 |
| 2010 | 6 | 0 |
| 2011 | 4 | 0 |
| 2012 | 2 | 0 |
| 2015 | 1 | 0 |
| 2017 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 2 | 0 |
| 2020 | 3 | 0 |
| 2021 | 4 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 3 | 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? (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 |
|---|---|---|---|
| * | K163293 | Colink™ Plating SystemSummary page 5…ial Equivalence: The subject components were demonstrated to be substantially equivalent to the following systems previously cleared by the FDA: Primary Predicate • K163293 – In2Bones CoLink™ Plating System Additional Predicates • K172300 - In2Bones CoLink™ Plating System • K983495- Syntec-Taic… | 2017 |
| * | K172300 | CoLink View Plating SystemSummary page 5…ntially equivalent to the following systems previously cleared by the FDA: Primary Predicate • K163293 – In2Bones CoLink™ Plating System Additional Predicates • K172300 - In2Bones CoLink™ Plating System • K983495- Syntec-Taichung Plates • K151886- Acumed Ankle Fracture System Gen III • K0… | 2017 |
| * | K983495 | Syntec-Taichung Non-Sterile Bone Plate and Screw Implants, Model#'S 222020-248120…Summary page 5…viously cleared by the FDA: Primary Predicate • K163293 – In2Bones CoLink™ Plating System Additional Predicates • K172300 - In2Bones CoLink™ Plating System • K983495- Syntec-Taichung Plates • K151886- Acumed Ankle Fracture System Gen III • K011335 – Synthes One-Third Tubular DCL Plate Th… | 1998 |
| * | K151886 | Acumed Ankle and Small Fragment Base Set UpdateSummary page 5…Predicate • K163293 – In2Bones CoLink™ Plating System Additional Predicates • K172300 - In2Bones CoLink™ Plating System • K983495- Syntec-Taichung Plates • K151886- Acumed Ankle Fracture System Gen III • K011335 – Synthes One-Third Tubular DCL Plate The subject CoLink™ Plating System made… | 2015 |
| * | K011335 | Synths One-Third Tubular DCL PlateSummary page 5…System Additional Predicates • K172300 - In2Bones CoLink™ Plating System • K983495- Syntec-Taichung Plates • K151886- Acumed Ankle Fracture System Gen III • K011335 – Synthes One-Third Tubular DCL Plate The subject CoLink™ Plating System made of Titanium Alloy and Commercially Pure Titanium a… | 2001 |
What descends from it? (14)
See all 149 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K191535 | CoLink® Mini Plating System | 2019 | 6 |
| K212487 | CoLink Vallux Plating System | 2021 | 4 |
| K213069 | CoLink NeoFuse Plating System | 2021 | 1 |
| K210060 | CoLink Mfx Implant System | 2021 | 1 |
| K200762 | CoLink Cfx Plating System | 2020 | 1 |
| K261154 | CoLink® & CoLag® Non-Sterile Screws | 2026 | 0 |
| 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)
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 22 years and passes through 7 companies; a new generation was cleared every 1.6 years on median.
- 26 of the 121 ancestors have a recall of any class.
- Of its descendants, K191535 (In2bones USA, LLC, 2019) has gone furthest, with 6 descendants of its own.
- 13 other devices also cite its predicate K163293.
How does its category compare?
All HRS devicesHRS Plate, 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 · 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, CoLink™ Plating System is indicated for stabilization and fixation of fractures, revision procedures, joint fusion, osteotomies and reconstruction of the small bones in the hand, wrist, foot and ankle in both pediatric and adult patients.
The In2Bones USA LLC, CoLink™ Afx Plating System is indicated for stabilization and fixation of fractures and osteotomies in the ankle, including tibia and fibula, in both pediatric and adult patients.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K181113 · printed Nov 6, 2026
Cite this page
510(k) Report. “K181113: CoLink™ Afx Plating System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K181113
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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