510(k) · Cleared
ClearedCoLink Plating System, Fracture and Correction System, RTS Implant System, NeoSpan Compression Staple 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 Aug 8, 2019 as substantially equivalent to K182402 (In2bones USA, LLC, 2018) and 8 other predicates after a 170-day review. Its family tree reaches back 16 generations to 1996.
- Decided
- Aug 8, 2019
- Review
- 170 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 9
Its longest line of descent runs back 16 generations to K962616 (1996). 214 ancestors in all, the oldest K780132 (1978). No later device cites it as a predicate yet.
- Root · 16 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
- 12 generations between
- 3 generations backK143385 Acumed Ankle Plating SystemAcumed, LLC · 2015
- 2 generations backK151886 Acumed Ankle and Small Fragment Base Set UpdateAcumed, LLC · 2015
- 1 generation backK181113 CoLink™ Afx Plating SystemIn2bones USA, LLC · 2018
- This deviceK190385 CoLink Plating System, Fracture and Correction System, RTS Implant…In2bones USA, LLC · 2019
Show all 16 generations
- Root · 16 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
- 15 generations backK982732 Synthes (Usa) Distal Radius Plate System (DRPS)Synthes · 1998
- 14 generations backK023007 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2002
- 13 generations backK030198 Hand Innovations, Inc. Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
- 12 generations backK032705 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
- 11 generations backK050932 Distal Volar Radius Anatomical Plate SystemHand Innovations, Inc. · 2005 · Recalled
- 10 generations backK051735 Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper…Smith & Nephew, Inc. · 2005
- 9 generations backK071563 Peri-Loc Periarticular Locked Plating SystemSmith & Nephew, Inc. · 2007
- 8 generations backK090675 Smith & Nephew, Inc. VLP Foot Plating, Screw System and AccessoriesSmith & Nephew, Inc. · 2009
- 7 generations backK100776 Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot SystemSynthes (Usa) · 2010
- 6 generations backK120070 Synthes Variable Angle LCP Elbow SystemSynthes USA · 2012 · Recalled
- 5 generations backK120717 Synthes Variable Angle LCP Elbow System (Medical and Posterolateral…Synthes USA · 2012
- 4 generations backK120854 Synthes VA LCP Ankle Trauma SystemSynthes USA · 2012
- 3 generations backK143385 Acumed Ankle Plating SystemAcumed, LLC · 2015
- 2 generations backK151886 Acumed Ankle and Small Fragment Base Set UpdateAcumed, LLC · 2015
- 1 generation backK181113 CoLink™ Afx Plating SystemIn2bones USA, LLC · 2018
- This deviceK190385 CoLink Plating System, Fracture and Correction System, RTS Implant…In2bones USA, LLC · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −16 | K962616 | Synthes Dorsal Distal Radius Plate (DDRP) System | Synthes (Usa) | 1996 | — |
| −15 | K982732 | Synthes (Usa) Distal Radius Plate System (DRPS) | Synthes | 1998 | — |
| −14 | K023007 | Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2002 | — |
| −13 | K030198 | Hand Innovations, Inc. Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2003 | — |
| −12 | K032705 | Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2003 | — |
| −11 | K050932 | Distal Volar Radius Anatomical Plate System | Hand Innovations, Inc. | 2005 | 1 |
| −10 | K051735 | Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper Extremity | Smith & Nephew, Inc. | 2005 | — |
| −9 | K071563 | Peri-Loc Periarticular Locked Plating System | Smith & Nephew, Inc. | 2007 | — |
| −8 | K090675 | Smith & Nephew, Inc. VLP Foot Plating, Screw System and Accessories | Smith & Nephew, Inc. | 2009 | — |
| −7 | K100776 | Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot System | Synthes (Usa) | 2010 | — |
| −6 | K120070 | Synthes Variable Angle LCP Elbow System | Synthes USA | 2012 | 1 |
| −5 | K120717 | Synthes Variable Angle LCP Elbow System (Medical and Posterolateral Distal… | Synthes USA | 2012 | — |
| −4 | K120854 | Synthes VA LCP Ankle Trauma System | Synthes USA | 2012 | — |
| −3 | K143385 | Acumed Ankle Plating System | Acumed, LLC | 2015 | — |
| −2 | K151886 | Acumed Ankle and Small Fragment Base Set Update | Acumed, LLC | 2015 | — |
| −1 | K181113 | CoLink™ Afx Plating System | In2bones USA, LLC | 2018 | — |
| 0 (this device) | K190385 | CoLink Plating System, Fracture and Correction System, RTS Implant System… | In2bones USA, LLC | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1979 | 1 | 0 |
| 1982 | 1 | 0 |
| 1989 | 2 | 0 |
| 1990 | 4 | 0 |
| 1991 | 1 | 0 |
| 1992 | 2 | 0 |
| 1993 | 3 | 0 |
| 1994 | 7 | 0 |
| 1995 | 7 | 0 |
| 1996 | 16 | 0 |
| 1997 | 7 | 0 |
| 1998 | 8 | 0 |
| 1999 | 9 | 0 |
| 2000 | 12 | 0 |
| 2001 | 16 | 0 |
| 2002 | 9 | 0 |
| 2003 | 9 | 0 |
| 2004 | 11 | 0 |
| 2005 | 12 | 0 |
| 2006 | 8 | 0 |
| 2007 | 5 | 0 |
| 2008 | 9 | 0 |
| 2009 | 6 | 0 |
| 2010 | 7 | 0 |
| 2011 | 8 | 0 |
| 2012 | 3 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 3 | 0 |
| 2017 | 3 | 0 |
| 2018 | 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? (9)
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 |
|---|---|---|---|
| * | K182402 | CoLink View Plating SystemSummary page 10…The subject components were demonstrated to be substantially equivalent to the following systems previously cleared by the FDA: • Primary Predicate: o K182402 – CoLink View Plating System • Secondary Predicates: o K180377 – Fracture and Correction System o K… | 2018 |
| * | K180377 | Fracture and Correction SystemSummary page 10…llowing systems previously cleared by the FDA: • Primary Predicate: o K182402 – CoLink View Plating System • Secondary Predicates: o K180377 – Fracture and Correction System o K181113 – CoLink Afx Plating System o K173491 – RTS Lesser MTP Implant… | 2018 |
| * | K181113 | CoLink™ Afx Plating SystemSummary page 10…Primary Predicate: o K182402 – CoLink View Plating System • Secondary Predicates: o K180377 – Fracture and Correction System o K181113 – CoLink Afx Plating System o K173491 – RTS Lesser MTP Implant System o K172300 – CoLink View Plating Sys… | 2018 |
| * | K173491 | RTS Lesser MTP Implant SystemSummary page 10…View Plating System • Secondary Predicates: o K180377 – Fracture and Correction System o K181113 – CoLink Afx Plating System o K173491 – RTS Lesser MTP Implant System o K172300 – CoLink View Plating System o K170518 – In2Bones Fracture and… | 2018 |
| * | K172300 | CoLink View Plating SystemSummary page 10…o K180377 – Fracture and Correction System o K181113 – CoLink Afx Plating System o K173491 – RTS Lesser MTP Implant System o K172300 – CoLink View Plating System o K170518 – In2Bones Fracture and Correction System o K163293 – CoLink Plati… | 2017 |
| * | K170518 | In2Bones Fracture and Correction SystemSummary page 10…o K181113 – CoLink Afx Plating System o K173491 – RTS Lesser MTP Implant System o K172300 – CoLink View Plating System o K170518 – In2Bones Fracture and Correction System o K163293 – CoLink Plating System o K161426 – NeoSpan Compressi… | 2017 |
| * | K163293 | Colink™ Plating SystemSummary page 10…K173491 – RTS Lesser MTP Implant System o K172300 – CoLink View Plating System o K170518 – In2Bones Fracture and Correction System o K163293 – CoLink Plating System o K161426 – NeoSpan Compression Staple Implant with Instruments o K153609 – RTS F… | 2017 |
| * | K161426 | NeoSpan Compression Staple Impant w/instrumentsSummary page 10…o K172300 – CoLink View Plating System o K170518 – In2Bones Fracture and Correction System o K163293 – CoLink Plating System o K161426 – NeoSpan Compression Staple Implant with Instruments o K153609 – RTS Flexible 1 MPJ Implant with Grommets • Re… | 2016 |
| * | K153609 | RTS Flexible 1 MPJ Implant w/GrommetsSummary page 10…es Fracture and Correction System o K163293 – CoLink Plating System o K161426 – NeoSpan Compression Staple Implant with Instruments o K153609 – RTS Flexible 1 MPJ Implant with Grommets • Reference Predicates: o K160553 – DePuy Synthes MR Conditional Lab… | 2016 |
| † | K160553 | DePuy Synthes 4.0 mm and 5.0 mm Locking Screws – MR Conditional, DePuy Synthes Wrist… | 2017 |
| † | K172975 | DePuy Synthes (USA) 5.0mm / 7.3mm Crimp Positioning Pins – MR Conditional, DePuy Synthes… | 2018 |
| † | K152631 | MPO Total Knee Systems MR Labeling | 2016 |
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 23 years and passes through 7 companies; a new generation was cleared every 1.6 years on median.
- 39 of the 214 ancestors have a recall of any class.
- 1 other device also cites its predicate K182402.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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…
Read the full statement (273 words)
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.
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).
The In2Bones NeoSpan® Compression Staple Implant w/instruments is indicated for hand and foot bone fragments, osteotomy fixation and joint arthrodesis.
The RTS® Flexible 1ST MPJ Implant w/Grommets is intended for use in the treatment of:
• Hallux limitus or hallux rigidus
• Painful rheumatoid arthritis
• Hallux abducto valgus associated with arthritis
• Unstable or painful joint from previous surgery
The RTS® Lesser MTP Implant is intended for use in the treatment of:
• Partial or complete dislocation of the lesser metatarsophalangeal joint
• Pain associated with either rheumatoid or osteoarthritis
• Repair of unsuccessful arthroplasties of the lesser metatarsophalangeal joint
• Stiffness at the lesser metatarsophalangeal joint associated with joint disease
• Hammertoe deformity where the proximal phalanx is dorsally located on the metatarsal in a fixed contracture state.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K190385 · printed Nov 6, 2026
Cite this page
510(k) Report. “K190385: CoLink Plating System, Fracture and Correction System, RTS Implant System, NeoSpan Compression Staple System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K190385
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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