Company · US
In2bones USA, LLC
FDA 510(k) clearances and medical device recalls filed under this name, 2014 to 2026. Name variants (Inc, Corp, punctuation) are merged.
45510(k) clearances (1 in 12 months)
16recalls (2 in 12 months)
14recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| HRS | Plate, Fixation, Bone | 22 |
| HWC | Screw, Fixation, Bone | 17 |
| JDR | Staple, Fixation, Bone | 6 |
| HSN | Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer | 4 |
| HTY | Pin, Fixation, Smooth | 3 |
| KWH | Prosthesis, Toe, Constrained, Polymer | 2 |
| KWI | Prosthesis, Elbow, Hemi-, Radial, Polymer | 2 |
| GFF | Bur, Surgical, General & Plastic Surgery | 1 |
| HSB | Rod, Fixation, Intramedullary And Accessories | 1 |
| HTN | Washer, Bolt Nut | 1 |
| LXH | Orthopedic Manual Surgical Instrument | 1 |
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 30, 2026 | K261154 | CoLink® & CoLag® Non-Sterile Screws In2Bones USA, LLC | HWC |
| Aug 13, 2024 | K241387 | CoLink NeoFuse MIS Plating System (see attached parts list) In2bones USA | HRS |
| May 24, 2024 | K233089 | NeoSpan® Compression Implant System In2bones USA, LLC | HRS |
| Apr 23, 2024 | K231699 | QUANTUM® Patient Specific Instrumentation (PSI) System In2bones Sas, FR | HSN |
| Jul 27, 2023 | K231236 | IBS-B MIS Beveled Screw System In2bones USA, LLC | HWC |
| Apr 6, 2023 | K230313 | QUANTUM Patient Specific Instrumentation (PSI) System In2bones Sas, FR | HSN |
| May 27, 2022 | K213698 | CoLink PCR Plating System In2bones USA, LLC | HRS |
| Mar 31, 2022 | K220260 | Hercules Syndesmosis Implant System In2bones USA, LLC | HTN |
| Dec 17, 2021 | K212872 | Avenger Radial Head System In2bones USA, LLC | KWI |
| Dec 13, 2021 | K213069 | CoLink NeoFuse Plating System In2bones USA, LLC | HRS |
| Nov 18, 2021 | K212487 | CoLink Vallux Plating System In2bones USA, LLC | HRS |
| Aug 11, 2021 | K211883 | QUANTUM® Patient Specific Instrumentation (PSI) System In2bones Sas, FR | HSN |
| May 4, 2021 | K203698 | CoLink Sfx Implant System In2bones USA, LLC | HTY |
| Mar 12, 2021 | K210060 | CoLink Mfx Implant System In2bones USA, LLC | HRS |
| Aug 20, 2020 | K201636 | Hercules Suture Anchor System In2bones USA, LLC | MBI |
| Jul 15, 2020 | K201149 | CoLink Plating System In2bones USA, LLC | HRS |
| Apr 23, 2020 | K200762 | CoLink Cfx Plating System In2bones USA, LLC | HRS |
| Jan 29, 2020 | K191380 | Quantum® Total Ankle Prosthesis In2bones Sas, FR | HSN |
| Jan 17, 2020 | K193543 | CoLink Plating System, Fracture and Correction System, CoLink Mini Plating System, CoLink View Plating System, CoLink Af In2bones USA, LLC | HRS |
| Jan 7, 2020 | K192754 | Avenger Radial Head System In2bones USA, LLC | KWI |
| Aug 8, 2019 | K190385 | CoLink Plating System, Fracture and Correction System, RTS Implant System, NeoSpan Compression Staple System In2bones USA, LLC | HRS |
| Jul 29, 2019 | K191535 | CoLink® Mini Plating System In2bones USA, LLC | HRS |
| Sep 27, 2018 | K182402 | CoLink View Plating System In2bones USA, LLC | HRS |
| Jun 20, 2018 | K180377 | Fracture and Correction System In2bones USA, LLC | HWC |
| Jun 15, 2018 | K181113 | CoLink Afx Plating System In2bones USA, LLC | HRS |
| Mar 15, 2018 | K173811 | TRIWAY Tibiotalocalcaneal (TTC) Arthrodesis System In2bones Sas, FR | HSB |
| Feb 23, 2018 | K173491 | RTS Lesser MTP Implant System In2bones USA, LLC | KWH |
| Jan 19, 2018 | K173616 | DIP Arthrodesis System In2bones Sas, FR | HTY |
| Nov 28, 2017 | K173121 | Ankle Fusion Plating System In2bones Sas, FR | HRS |
| Nov 28, 2017 | K170688 | PITStop® implant In2bones Sas, FR | HWC |
| Nov 27, 2017 | K172300 | CoLink View Plating System In2bones USA, LLC | HRS |
| Jul 14, 2017 | K170518 | In2Bones Fracture and Correction System In2bones USA, LLC | HRS |
| May 10, 2017 | K170594 | I.B.S. osteosynthesis screws In2bones Sas, FR | HWC |
| May 5, 2017 | K163293 | Colink Plating System In2bones USA, LLC | HRS |
| Oct 24, 2016 | K161426 | NeoSpan Compression Staple Impant w/instruments In2bones USA, LLC | JDR |
| Oct 6, 2016 | K160174 | I.B.S. 2.0 Osteosynthesis screw In2bones Sas, FR | HWC |
| Sep 8, 2016 | K153609 | RTS Flexible 1 MPJ Implant w/Grommets In2bones USA, LLC | KWH |
| Jun 10, 2016 | K160995 | NEOVIEW Plating System In2bones Sas, FR | HRS |
| Mar 21, 2016 | K153770 | OS2(R)-VP Varisation Staple In2bones Sas, FR | JDR |
| Feb 18, 2016 | K153395 | OS2-C Compression Staple In2bones Sas, FR | JDR |
| Feb 1, 2016 | K153204 | In2Bones Kirschner wire In2bones Sas, FR | HTY |
| Feb 26, 2015 | K143323 | OS2-V Varisation Staple In2bones Sas, FR | JDR |
| Jul 30, 2014 | K132912 | DUAFIT INTERGPHALANGEAL IMPLANT, PEEK-FUSE INTERPHALANGEAL IMPLANT In2bones Sas | HWC |
| May 1, 2014 | K131920 | STABILIZATION SCREW In2bones Sas | HWC |
| Apr 4, 2014 | K132911 | I.B.S SNAP-OFF SCREW / SOLAFIX SNAP-OFF SCREW In2bones Sas, FR | HWC |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 14, 2026 | In2bones USA, LLC REF: P65 ST862
CoLag SCREW, FT, 6.7X62.5 mm Open, Classified |
HWC | K170518 |
| Jun 8, 2026 | In2bones USA, LLC 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 S Open, Classified |
JDR | K161426 |
| Mar 20, 2024 | In2Bones, SAS I.B.S 6.5-C Compression screw - diam 6.5mm lg 80mm,Part Number S65 ST180 Open, Classified |
HWC | K131920 |
| Mar 20, 2024 | In2Bones, SAS I.B.S 6.5-C Compression screw - diam 6.5mm lg 75mm,Part Number S65 ST175 Open, Classified |
HWC | K131920 |
| Aug 18, 2021 | In2bones USA, LLC 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. Terminated |
LXH | None listed |
| Feb 9, 2021 | In2Bones, SAS In2Bones Shannon Percutaneous Burr - Product Usage: indicated for forefoot mini-invasive and percutaneous surgery. Terminated |
GFF | None listed |
| Nov 14, 2018 | In2bones USA, LLC NeoSpan SuperElastic Compression Staple w/Instruments, Size 10x10x10, Part Number T50 SN010 Terminated |
JDR | K161426 |
| Jul 16, 2018 | In2bones USA, LLC 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 Terminated |
HWC | K163293 |
| Jul 16, 2018 | In2bones USA, LLC 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, revisio Terminated |
HWC | K163293 |
| Jul 13, 2017 | In2Bones, SAS Non-Locking screws in the following lengths:
(a) NEO(R) 0.27 - 10 mm, REF W27 ST010
(b) NEO(R) 0.27 - 12 mm, REF W27 ST012
(c) DRP 0.27 - 12 mm, REF W27 ST012
(d) NEO(R) 0.27 - 14 mm, REF W27 ST01 Terminated |
HRS | K160995 |
| Jan 6, 2017 | In2Bones, SAS NEOVIEW(R) SCREWS SET, REF W27 ST900, STERILE R
The NEOVIEW Plating System is intended for fixation of intra-articular and extraarticular fractures of the distal radius and reconstruction of the dist Terminated |
HRS | K160995 |
| Jan 6, 2017 | In2Bones, SAS NEO SCREW 02.7-14MM LOCKING, REF W27 ST114, In2Bones, 28 chemin du petit bois, 69130 Ecully - France
The NEOVIEW Plating System is intended for fixation of intra-articular and extraarticular fracture Terminated |
HRS | K160995 |
| Jan 6, 2017 | In2Bones, SAS SCREW 02.7-12MM LOCKING, REF W27 ST112: a) DRP, b) NEO, In2Bones, 28 chemin du petit bois, 69130 Ecully - France
The NEOVIEW Plating System is intended for fixation of intra-articular and extraartic Terminated |
HRS | K160995 |
| Dec 9, 2015 | In2Bones, SAS IBS - Osteosynthesis screws for bone fixation Model S25 ST014. Terminated |
HWC | K131920 |
| Mar 25, 2015 | In2Bones, SAS DUAFIT(R) PIP 0o CA SIZE 3, REF A60 SP003, STERILE R, Rx only.
Interphalangeal implant. Terminated |
HWC | K132912 |
| Mar 25, 2015 | In2Bones, SAS DUAFIT(R) PIP 0o CA SIZE 2, REF A60 SP002, STERILE R, Rx only.
Interphalangeal implant. Terminated |
HWC | K132912 |