510(k) · Cleared
Recalled · Class II · 2018Colink™ 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 May 5, 2017 as substantially equivalent to K083447 (Memometal Technologies, 2009) and 1 other predicate after a 164-day review. Its family tree reaches back 4 generations to 2000. 21 later devices descend from it. It has been recalled 2 times.
- Decided
- May 5, 2017
- Review
- 164 days
- Class
- Class II
- Product code
- HRS
- Recalls
- 2
- Predicates
- 2
Its longest line of descent runs back 4 generations to K000684 (2000). 13 ancestors in all. 21 later devices descend from it, 14 citing it directly.
- Root · 4 generations backK000684 Small Fragment Dynamic Compression Locking (DCL) SystemSynthes (Usa) · 2000 · Recalled
- 3 generations backK011335 Synths One-Third Tubular DCL PlateSynthes (Usa) · 2001 · Recalled
- 2 generations backK102282 The Varia Fibula Locked Plating System Line Extension Addition of…Howmedica Osteonics Corp., Dba Stryker Orthopaedics · 2010
- 1 generation backK123000 Integra Total Foot SystemsIntegra LifeSciences Corporation · 2012
- This deviceK163293 Colink™ Plating SystemIn2bones USA, LLC · 2017
- Descendant · cites it directly · 16 of its ownK172300 CoLink View Plating SystemIn2bones USA, LLC · 2017
- Descendant · cites it directly · 14 of its ownK181113 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
Showing 5 of 21 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 21 · See all- K172300CoLink View Plating SystemIn2bones USA, LLC · 2017 · cites it directly16descendants
- K181113CoLink™ Afx Plating SystemIn2bones USA, LLC · 2018 · cites it directly14descendants
- 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
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K000684 | Small Fragment Dynamic Compression Locking (DCL) System | Synthes (Usa) | 2000 | 1 |
| −3 | K011335 | Synths One-Third Tubular DCL Plate | Synthes (Usa) | 2001 | 2 |
| −2 | K102282 | The Varia Fibula Locked Plating System Line Extension Addition of Straight… | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2010 | — |
| −1 | K123000 | Integra Total Foot Systems | Integra LifeSciences Corporation | 2012 | — |
| 0 (this device) | K163293 | Colink™ Plating System | In2bones USA, LLC | 2017 | — |
| +1 | K172300 | CoLink View Plating System | In2bones USA, LLC | 2017 | — |
| +1 | 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 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
| 2006 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 2 | 0 |
| 2010 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 4 | 0 |
| 2020 | 3 | 0 |
| 2021 | 4 | 0 |
| 2022 | 1 | 0 |
| 2024 | 2 | 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? (2)
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 |
|---|---|---|---|
| * | K083447 | Memometal Anchorage Bone Plate System, Models PLSS/PLSL, PLP10/PLP20/PLP30/PLP40/PLP50Summary page 4…87 HRS, HWC III. Predicate Device Predicate Device: Stryker (Memometal) Anchorage Bone Plate System, K083447 Integra Total Foot System, K123000 Reference Device: In2Bones SAS, I.B.S. Osteosy… | 2009 |
| * | K123000 | Integra Total Foot SystemsSummary page 4…vice: Stryker (Memometal) Anchorage Bone Plate System, K083447 Integra Total Foot System, K123000 Reference Device: In2Bones SAS, I.B.S. Osteosynthesis screws, K131920 In2Bones US… | 2012 |
| † | K131920 | Stabilization Screw | 2014 |
| † | K153609 | RTS Flexible 1 MPJ Implant w/Grommets | 2016 |
| † | K161426 | NeoSpan Compression Staple Impant w/instruments | 2016 |
What descends from it? (21)
See all 2114 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K172300 | CoLink View Plating System | 2017 | 16 |
| K181113 | CoLink™ Afx Plating System | 2018 | 14 |
| K191535 | CoLink® Mini Plating System | 2019 | 6 |
| K212487 | CoLink Vallux Plating System | 2021 | 4 |
| K182402 | CoLink View Plating System | 2018 | 2 |
| K213069 | CoLink NeoFuse Plating System | 2021 | 1 |
| K210060 | CoLink Mfx Implant System | 2021 | 1 |
| K200762 | CoLink Cfx Plating System | 2020 | 1 |
| K190391 | TDM Plate and Screw Systems | 2019 | 1 |
| K213698 | CoLink PCR Plating System | 2022 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 16, 2018 | Class II | Z-2880-2018 | Process control | CoLink(TM) Lapidus Plate +2mm Right and Left, were laser marked incorrectly. In these lots, right plates were laser marked as left plates and the left plates were laser marked as right plates. |
| Jul 16, 2018 | Class II | Z-2879-2018 | Process control | CoLink(TM) Lapidus Plate +2mm Right and Left, were laser marked incorrectly. In these lots, right plates were laser marked as left plates and the left plates were laser marked as right plates. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 17 years and passes through 4 companies; a new generation was cleared every 4.4 years on median.
- 5 of the 13 ancestors have a recall of any class.
- Of its descendants, K172300 (In2bones USA, LLC, 2017) has gone furthest, with 16 descendants of its own.
- 9 other devices also cite its predicate K083447.
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, 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K163293 · printed Nov 6, 2026
Cite this page
510(k) Report. “K163293: Colink™ 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/K163293
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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