510(k) · Cleared
ClearedCoLink Plating System, Fracture and Correction System, CoLink Mini Plating System, CoLink View Plating System, CoLink 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 Jan 17, 2020 as substantially equivalent to K191535 (In2bones USA, LLC, 2019) and 6 other predicates after a 28-day review. Its family tree reaches back 17 generations to 1996.
- Decided
- Jan 17, 2020
- Review
- 28 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 7
Its longest line of descent runs back 17 generations to K962616 (1996). 200 ancestors in all, the oldest K792022 (1979). No later device cites it as a predicate yet.
- Root · 17 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
- 13 generations between
- 3 generations backK151886 Acumed Ankle and Small Fragment Base Set UpdateAcumed, LLC · 2015
- 2 generations backK181113 CoLink™ Afx Plating SystemIn2bones USA, LLC · 2018
- 1 generation backK191535 CoLink® Mini Plating SystemIn2bones USA, LLC · 2019
- This deviceK193543 CoLink Plating System, Fracture and Correction System, CoLink Mini…In2bones USA, LLC · 2020
Show all 17 generations
- Root · 17 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
- 16 generations backK982732 Synthes (Usa) Distal Radius Plate System (DRPS)Synthes · 1998
- 15 generations backK023007 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2002
- 14 generations backK030198 Hand Innovations, Inc. Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
- 13 generations backK032705 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
- 12 generations backK050932 Distal Volar Radius Anatomical Plate SystemHand Innovations, Inc. · 2005 · Recalled
- 11 generations backK051735 Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper…Smith & Nephew, Inc. · 2005
- 10 generations backK071563 Peri-Loc Periarticular Locked Plating SystemSmith & Nephew, Inc. · 2007
- 9 generations backK090675 Smith & Nephew, Inc. VLP Foot Plating, Screw System and AccessoriesSmith & Nephew, Inc. · 2009
- 8 generations backK100776 Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot SystemSynthes (Usa) · 2010
- 7 generations backK120070 Synthes Variable Angle LCP Elbow SystemSynthes USA · 2012 · Recalled
- 6 generations backK120717 Synthes Variable Angle LCP Elbow System (Medical and Posterolateral…Synthes USA · 2012
- 5 generations backK120854 Synthes VA LCP Ankle Trauma SystemSynthes USA · 2012
- 4 generations backK143385 Acumed Ankle Plating SystemAcumed, LLC · 2015
- 3 generations backK151886 Acumed Ankle and Small Fragment Base Set UpdateAcumed, LLC · 2015
- 2 generations backK181113 CoLink™ Afx Plating SystemIn2bones USA, LLC · 2018
- 1 generation backK191535 CoLink® Mini Plating SystemIn2bones USA, LLC · 2019
- This deviceK193543 CoLink Plating System, Fracture and Correction System, CoLink Mini…In2bones USA, LLC · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −17 | K962616 | Synthes Dorsal Distal Radius Plate (DDRP) System | Synthes (Usa) | 1996 | — |
| −16 | K982732 | Synthes (Usa) Distal Radius Plate System (DRPS) | Synthes | 1998 | — |
| −15 | K023007 | Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2002 | — |
| −14 | K030198 | Hand Innovations, Inc. Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2003 | — |
| −13 | K032705 | Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2003 | — |
| −12 | K050932 | Distal Volar Radius Anatomical Plate System | Hand Innovations, Inc. | 2005 | 1 |
| −11 | K051735 | Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper Extremity | Smith & Nephew, Inc. | 2005 | — |
| −10 | K071563 | Peri-Loc Periarticular Locked Plating System | Smith & Nephew, Inc. | 2007 | — |
| −9 | K090675 | Smith & Nephew, Inc. VLP Foot Plating, Screw System and Accessories | Smith & Nephew, Inc. | 2009 | — |
| −8 | K100776 | Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot System | Synthes (Usa) | 2010 | — |
| −7 | K120070 | Synthes Variable Angle LCP Elbow System | Synthes USA | 2012 | 1 |
| −6 | K120717 | Synthes Variable Angle LCP Elbow System (Medical and Posterolateral Distal… | Synthes USA | 2012 | — |
| −5 | K120854 | Synthes VA LCP Ankle Trauma System | Synthes USA | 2012 | — |
| −4 | K143385 | Acumed Ankle Plating System | Acumed, LLC | 2015 | — |
| −3 | K151886 | Acumed Ankle and Small Fragment Base Set Update | Acumed, LLC | 2015 | — |
| −2 | K181113 | CoLink™ Afx Plating System | In2bones USA, LLC | 2018 | — |
| −1 | K191535 | CoLink® Mini Plating System | In2bones USA, LLC | 2019 | — |
| 0 (this device) | K193543 | CoLink Plating System, Fracture and Correction System, CoLink Mini Plating… | In2bones USA, LLC | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 3 | 0 |
| 1991 | 1 | 0 |
| 1992 | 2 | 0 |
| 1993 | 3 | 0 |
| 1994 | 7 | 0 |
| 1995 | 7 | 0 |
| 1996 | 16 | 0 |
| 1997 | 6 | 0 |
| 1998 | 7 | 0 |
| 1999 | 9 | 0 |
| 2000 | 11 | 0 |
| 2001 | 16 | 0 |
| 2002 | 8 | 0 |
| 2003 | 8 | 0 |
| 2004 | 11 | 0 |
| 2005 | 12 | 0 |
| 2006 | 8 | 0 |
| 2007 | 4 | 0 |
| 2008 | 9 | 0 |
| 2009 | 6 | 0 |
| 2010 | 7 | 0 |
| 2011 | 8 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 3 | 0 |
| 2018 | 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 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? (7)
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 |
|---|---|---|---|
| * | K191535 | CoLink® Mini Plating SystemSummary page 7…The subject components were demonstrated to be substantially equivalent to the following systems previously cleared by the FDA: • Primary Predicate: o K191535 – CoLink Mini Plating System • Secondary Predicates: o K182402 / K172300 – CoLink View Plating System… | 2019 |
| * | K182402 | CoLink View Plating SystemSummary page 7…llowing systems previously cleared by the FDA: • Primary Predicate: o K191535 – CoLink Mini Plating System • Secondary Predicates: o K182402 / K172300 – CoLink View Plating System o K180377 – Fracture and Correction System o K181113 – CoLink Afx… | 2018 |
| * | K172300 | CoLink View Plating SystemSummary page 7…stems previously cleared by the FDA: • Primary Predicate: o K191535 – CoLink Mini Plating System • Secondary Predicates: o K182402 / K172300 – CoLink View Plating System o K180377 – Fracture and Correction System o K181113 – CoLink Afx Plating Sy… | 2017 |
| * | K180377 | Fracture and Correction SystemSummary page 7…ry Predicate: o K191535 – CoLink Mini Plating System • Secondary Predicates: o K182402 / K172300 – CoLink View Plating System o K180377 – Fracture and Correction System o K181113 – CoLink Afx Plating System o K170518 – In2Bones Fracture and… | 2018 |
| * | K181113 | CoLink™ Afx Plating SystemSummary page 7…ng System • Secondary Predicates: o K182402 / K172300 – CoLink View Plating System o K180377 – Fracture and Correction System o K181113 – CoLink Afx Plating System o K170518 – In2Bones Fracture and Correction System o K163293 – CoLink Platin… | 2018 |
| * | K170518 | In2Bones Fracture and Correction SystemSummary page 7…o K182402 / K172300 – CoLink View Plating System o K180377 – Fracture and Correction System o K181113 – CoLink Afx Plating System o K170518 – In2Bones Fracture and Correction System o K163293 – CoLink Plating System The subject In2Bones USA, LLC product fa… | 2017 |
| * | K163293 | Colink™ Plating SystemSummary page 7…K180377 – Fracture and Correction System o K181113 – CoLink Afx Plating System o K170518 – In2Bones Fracture and Correction System o K163293 – CoLink Plating System The subject In2Bones USA, LLC product families have been demonstrated to be substantially equivalent to… | 2017 |
What descends from it?
No later submission names this one as a predicate yet.
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 24 years and passes through 7 companies; a new generation was cleared every 1.2 years on median.
- 35 of the 200 ancestors have a recall of any class.
- 1 other device also cites its predicate K191535.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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 / CoLink® View Plating System / CoLink® Mini 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…
Read the full statement (153 words)
The In2Bones USA LLC, CoLink® Plating System / CoLink® View Plating System / CoLink® Mini 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.
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/K193543 · printed Nov 6, 2026
Cite this page
510(k) Report. “K193543: CoLink Plating System, Fracture and Correction System, CoLink Mini Plating System, CoLink View Plating System, 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/K193543
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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