In2bones USA, LLC
Cordova, TN, US
IN2BONES USA, LLC appears in FDA device records in Cordova, TN. FDA records list 27 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 5 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 27 510(k) clearances for In2bones USA, LLC between 2016 and 2026. The busiest year on record is 2020, with 5. The most recent is 2026, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2016 | 2 |
| 2017 | 3 |
| 2018 | 4 |
| 2019 | 2 |
| 2020 | 5 |
| 2021 | 5 |
| 2022 | 2 |
| 2023 | 1 |
| 2024 | 2 |
| 2026 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K261154 | CoLink® & CoLag® Non-Sterile Screws | HWC | Substantially Equivalent | |
| K241387 | CoLink NeoFuse MIS Plating System (see attached parts list) | HRS | Substantially Equivalent | |
| K233089 | NeoSpan® Compression Implant System | HRS | Substantially Equivalent | |
| K231236 | IBS-B MIS Beveled Screw System | HWC | Substantially Equivalent | |
| K213698 | CoLink PCR Plating System | HRS | Substantially Equivalent | |
| K220260 | Hercules Syndesmosis Implant System | HTN | Substantially Equivalent | |
| K212872 | Avenger Radial Head System | KWI | Substantially Equivalent | |
| K213069 | CoLink NeoFuse Plating System | HRS | Substantially Equivalent | |
| K212487 | CoLink Vallux Plating System | HRS | Substantially Equivalent | |
| K203698 | CoLink Sfx Implant System | HTY | Substantially Equivalent | |
| K210060 | CoLink Mfx Implant System | HRS | Substantially Equivalent | |
| K201636 | Hercules Suture Anchor System | MBI | Substantially Equivalent | |
| K201149 | CoLink Plating System | HRS | Substantially Equivalent | |
| K200762 | CoLink Cfx Plating System | HRS | Substantially Equivalent | |
| K193543 | CoLink Plating System, Fracture and Correction System, CoLink Mini Plating System, CoLink View Plating System, CoLink Afx Plating System | HRS | Substantially Equivalent | |
| K192754 | Avenger Radial Head System | KWI | Substantially Equivalent | |
| K190385 | CoLink Plating System, Fracture and Correction System, RTS Implant System, NeoSpan Compression Staple System | HRS | Substantially Equivalent | |
| K191535 | CoLink® Mini Plating System | HRS | Substantially Equivalent | |
| K182402 | CoLink View Plating System | HRS | Substantially Equivalent | |
| K180377 | Fracture and Correction System | HWC | Substantially Equivalent | |
| K181113 | CoLink™ Afx Plating System | HRS | Substantially Equivalent | |
| K173491 | RTS Lesser MTP Implant System | KWH | Substantially Equivalent | |
| K172300 | CoLink View Plating System | HRS | Substantially Equivalent | |
| K170518 | In2Bones Fracture and Correction System | HRS | Substantially Equivalent | |
| K163293 | Colink™ Plating System | HRS | Substantially Equivalent | |
| K161426 | NeoSpan Compression Staple Impant w/instruments | JDR | Substantially Equivalent | |
| K153609 | RTS Flexible 1 MPJ Implant w/Grommets | KWH | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3011580264 | 3011580264 | IN2BONES USA, LLC | 7750a Trinity Rd, Cordova, TN 38018 US | 2026 | and 4 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- HWRDriver, Prosthesis
- MBIFastener, Fixation, Nondegradable, Soft Tissue
- FZXGuide, Surgical, Instrument
- LXHOrthopedic Manual Surgical Instrument
- HXIPasser, Wire, Orthopedic
- HTYPin, Fixation, Smooth
- HRSPlate, Fixation, Bone
- KWIProsthesis, Elbow, Hemi-, Radial, Polymer
- KWHProsthesis, Toe, Constrained, Polymer
- HWCScrew, Fixation, Bone
- JDRStaple, Fixation, Bone
- HWTTemplate
- FSMTray, Surgical, Instrument
- HTNWasher, Bolt Nut
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2355-2026 | NeoSpan SuperElastic Compression Staple w/Instruments Catalog Number and Product Name T50 SN010 NeoSpan SuperElastic Compression Staple w/Instruments, Size 10x10x10 UDI-DI Code: 00817906020083 T50 SN012 NeoSpan SuperElastic Compression Staple w/Instruments, Size 12x12x12 UDI-DI Code: 00817906020090 T50 SN020 NeoSpan SuperElastic Compression Staple w/Instruments, Size 20x20x20 UDI-DI Code: 00817906020151 T50 SN110 NeoSpan SuperElastic Compression Staple w/Instruments, Size 10x15x13 UDI-DI Code: 00817906020113 T50 SN115 NeoSpan SuperElastic Compression Staple w/Instruments, Size 15Wx15x15 UDI-DI Code: 00817906020137 T50 SN118 NeoSpan SuperElastic Compression Staple w/Instruments, Size 18x14x14 UDI-DI Code: 00810021861364 Single/multiple component metallic bone fixation appliances and accessories The In2Bones USA NeoSpan" Compression Staple Implant w/instruments is indicated for hand and foot bone fragments, osteotomy fixation and joint arthrodesis. | Due to the Magnetic Resonance Conditional Symbol missing on the carton, inner tray, and patient label. | Class II | Open, Classified | |
| Z-2506-2021 | CoLink Bone Graft Harvester, 8mm, Sterile, Disposable, REF G05 S1008 - Product Usage: is a general instrument intended for assisting surgeons in the manipulation of bone during surgical procedures. | Complaints were received of CoLink Bone Graft Harvesters breaking at the outer tube weld site. | Class II | Terminated | |
| Z-0670-2019 | NeoSpan SuperElastic Compression Staple w/Instruments, Size 10x10x10, Part Number T50 SN010 | The NeoSpan Compression Staple (10x10x10) kits from two lots contain the wrong size drill bit. They contain a 3mm drill bit instead of a 2mm drill bit. | Class II | Terminated | |
| Z-2880-2018 | CoLink(TM) Lapidus Plate XP, +2 mm, Left, REF P40 ST265, QTY 1, In2Bones Product Usage: 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. | 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. | Class II | Terminated | |
| Z-2879-2018 | CoLink(TM) Lapidus Plate XP, +2 mm, Right, REF P40 ST165, QTY 1, In2Bones Product Usage: 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. | 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. | Class II | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain