Data / Medical devices / France / In2Bones SAS
In2Bones SAS: FDA-registered device maker in Saint-Priest Rhone, France, 11 510(k) clearances
In2Bones SAS is registered with the FDA (registration 3010470577) in Saint-Priest Rhone, France. It lists 28 device types. The FDA files 11 510(k) clearances under its listings, the newest dated March 15, 2018. 6 recall events name it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3010470577
- Address
- Immeuble Sequoia 3 97 Allee Alexandre Borodine, Saint-Priest Rhone, France, 69800
- Owner or operator
- In2Bones SAS (10046803)
- Roles
- Exporter to the US, Specification developer
- First device listed
- May 15, 2014
- Registered through
- 2027
- Brand names listed
- AKILINK, All manual instruments, Ankle Fusion Plating System, Awl, Drill bits, Driver, Posthesis, GENERIC LID REUSABLE INSTRUMENTS, Handle and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Awl | HWJ | 1 | Exporter to the US, Specification developer | accessdata.fda.gov |
| Bender | HXW | 1 | Exporter to the US, Specification developer | accessdata.fda.gov |
| Bit, Surgical | GFG | 1 | Exporter to the US, Specification developer | accessdata.fda.gov |
| Bur, Surgical, General & Plastic Surgery | GFF | 1 | Exporter to the US, Specification developer | accessdata.fda.gov |
| Driver, Prosthesis | HWR | 1 | Exporter to the US, Specification developer | accessdata.fda.gov |
| Forceps, Wire Holding | HYA | 1 | Exporter to the US, Specification developer | accessdata.fda.gov |
| Gauge, Depth | HTJ | 1 | Exporter to the US, Specification developer | accessdata.fda.gov |
| Guide, Surgical, Instrument | FZX | 1 | Exporter to the US, Specification developer | accessdata.fda.gov |
| Handle, Scalpel | GDZ | 1 | Exporter to the US, Specification developer | accessdata.fda.gov |
| Impactor | HWA | 1 | Exporter to the US, Specification developer | accessdata.fda.gov |
| Instrument, Ligature Passing And Knot Tying | HCF | 1 | Exporter to the US, Specification developer | accessdata.fda.gov |
| Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | HWE | 1 | Exporter to the US, Specification developer | accessdata.fda.gov |
| Kit, Surgical Instrument, Disposable | KDD | 1 | Exporter to the US, Specification developer | accessdata.fda.gov |
| Orthopedic Manual Surgical Instrument | LXH | 1 | Exporter to the US, Specification developer | accessdata.fda.gov |
| Pin, Fixation, Smooth | HTY | 2 | Exporter to the US, Specification developer | accessdata.fda.gov |
| Pin, Fixation, Threaded | JDW | 2 | Exporter to the US, Specification developer | accessdata.fda.gov |
| Plate, Fixation, Bone | HRS | 2 | Exporter to the US, Specification developer | accessdata.fda.gov |
| Positioner, Socket | KIL | 1 | Exporter to the US, Specification developer | accessdata.fda.gov |
| Reamer | HTO | 1 | Specification developer | accessdata.fda.gov |
| Rod, Fixation, Intramedullary And Accessories | HSB | 2 | Exporter to the US, Specification developer | accessdata.fda.gov |
| Screw, Fixation, Bone | HWC | 2 | Exporter to the US, Specification developer | accessdata.fda.gov |
| Screwdriver | HXX | 1 | Exporter to the US, Specification developer | accessdata.fda.gov |
| Staple Driver | HXJ | 1 | Exporter to the US, Specification developer | accessdata.fda.gov |
| Staple, Fixation, Bone | JDR | 2 | Exporter to the US, Specification developer | accessdata.fda.gov |
| Starter, Bone Screw | HWD | 1 | Exporter to the US, Specification developer | accessdata.fda.gov |
| Tape, Measuring, Rulers And Calipers | FTY | 1 | Exporter to the US, Specification developer | accessdata.fda.gov |
| Template | HWT | 1 | Exporter to the US, Specification developer | accessdata.fda.gov |
| Tray, Surgical, Instrument | FSM | 1 | Exporter to the US, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| March 15, 2018 | K173811 | TRIWAY Tibiotalocalcaneal (TTC) Arthrodesis System | HSB | Substantially Equivalent | In2bones Sas | accessdata.fda.gov |
| November 28, 2017 | K173121 | Ankle Fusion Plating System | HRS | Substantially Equivalent | In2bones Sas | accessdata.fda.gov |
| November 28, 2017 | K170688 | PITStop® implant | HWC | Substantially Equivalent | In2bones Sas | accessdata.fda.gov |
| May 10, 2017 | K170594 | I.B.S. osteosynthesis screws | HWC | Substantially Equivalent | In2bones Sas | accessdata.fda.gov |
| October 6, 2016 | K160174 | I.B.S. 2.0 Osteosynthesis screw | HWC | Substantially Equivalent | In2bones Sas | accessdata.fda.gov |
| March 21, 2016 | K153770 | OS2(R)-VP Varisation Staple | JDR | Substantially Equivalent | In2bones Sas | accessdata.fda.gov |
| February 1, 2016 | K153204 | In2Bones Kirschner wire | HTY | Substantially Equivalent | In2bones Sas | accessdata.fda.gov |
| February 26, 2015 | K143323 | OS2-V Varisation Staple | JDR | Substantially Equivalent | In2bones Sas | accessdata.fda.gov |
| July 30, 2014 | K132912 | DUAFIT INTERGPHALANGEAL IMPLANT, PEEK-FUSE INTERPHALANGEAL IMPLANT | HWC | Substantially Equivalent | In2bones Sas | accessdata.fda.gov |
| May 1, 2014 | K131920 | STABILIZATION SCREW | HWC | Substantially Equivalent | In2bones Sas | accessdata.fda.gov |
| April 4, 2014 | K132911 | I.B.S SNAP-OFF SCREW / SOLAFIX SNAP-OFF SCREW | HWC | Substantially Equivalent | In2bones Sas | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| January 26, 2024 | 94063 | Class II | Ongoing | I.B.S 6.5-C Compression screw - diam 6.5mm lg 75mm,Part Number S65 ST175 | This Field Action is being conducted following the identification of a batch mix-up between I.B.S Compression screws diameter 6.5mm length 75mm and I.B.S Compression screws diameter 6.5mm length 80mm. The screws of the batches concerned by the recall may have different lengths from those issued on their labels. | accessdata.fda.gov |
| February 9, 2021 | 87341 | Class II | Terminated | In2Bones Shannon Percutaneous Burr - Product Usage: indicated for forefoot mini-invasive and percutaneous surgery. | This Field Action is being conducted following identification of manufacturing non-conformity of some batches of Shannon burrs diameter 2.0mm length 20mm, possibly causing the breakage of the burr during use. | accessdata.fda.gov |
| July 13, 2017 | 77781 | Class II | Terminated | 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 ST014 (e) NEO(R) 0.27 - 16 m | The firm received several customer complaints reporting some perioperative breakages of NE0411 Non-Locking screws when inserting the screw into the radius diaphysis | accessdata.fda.gov |
| December 19, 2016 | 76104 | Class II | Terminated | 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 extraarticular fractures of the | Dimensional non-conformity of the thread on the screw head. | accessdata.fda.gov |
| November 18, 2015 | 72711 | Class II | Terminated | IBS - Osteosynthesis screws for bone fixation Model S25 ST014. | One batch of osteosynthesis screws were manufactured with the incorrect Torx imprint on the screw head. | accessdata.fda.gov |
| March 9, 2015 | 70736 | Class II | Terminated | DUAFIT(R) PIP 0o CA SIZE 2, REF A60 SP002, STERILE R, Rx only. Interphalangeal implant. | Dimensional non-conformity leading to the impossibility to introduce the implant in the dedicated holder. | accessdata.fda.gov |
Compare with other makers
- All makers of Screw, Fixation, Bone
- All makers of Kit, Surgical Instrument, Disposable
- All makers of Bender
- All makers of Screwdriver
- All makers of Impactor
- All makers of Rod, Fixation, Intramedullary And Accessories
Updated March 20, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.