In2Bones SAS
Saint-Priest Rhone, FR
In2Bones SAS appears in FDA device records in Saint-Priest Rhone, FR. FDA records list 18 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 10 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 18 510(k) clearances for In2Bones SAS between 2014 and 2024. The busiest year on record is 2016, with 5. The most recent is 2024, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2014 | 3 |
| 2015 | 1 |
| 2016 | 5 |
| 2017 | 3 |
| 2018 | 2 |
| 2020 | 1 |
| 2021 | 1 |
| 2023 | 1 |
| 2024 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K231699 | QUANTUM® Patient Specific Instrumentation (PSI) System | HSN | Substantially Equivalent | |
| K230313 | QUANTUM Patient Specific Instrumentation (PSI) System | HSN | Substantially Equivalent | |
| K211883 | QUANTUM® Patient Specific Instrumentation (PSI) System | HSN | Substantially Equivalent | |
| K191380 | Quantum® Total Ankle Prosthesis | HSN | Substantially Equivalent | |
| K173811 | TRIWAY Tibiotalocalcaneal (TTC) Arthrodesis System | HSB | Substantially Equivalent | |
| K173616 | DIP Arthrodesis System | HTY | Substantially Equivalent | |
| K173121 | Ankle Fusion Plating System | HRS | Substantially Equivalent | |
| K170688 | PIT’Stop® implant | HWC | Substantially Equivalent | |
| K170594 | I.B.S. osteosynthesis screws | HWC | Substantially Equivalent | |
| K160174 | I.B.S. 2.0 Osteosynthesis screw | HWC | Substantially Equivalent | |
| K160995 | NEOVIEW Plating System | HRS | Substantially Equivalent | |
| K153770 | OS2(R)-VP Varisation Staple | JDR | Substantially Equivalent | |
| K153395 | OS2-C Compression Staple | JDR | Substantially Equivalent | |
| K153204 | In2Bones Kirschner wire | HTY | Substantially Equivalent | |
| K143323 | OS2-V Varisation Staple | JDR | Substantially Equivalent | |
| K132912 | DUAFIT INTERGPHALANGEAL IMPLANT, PEEK-FUSE INTERPHALANGEAL IMPLANT | HWC | Substantially Equivalent | |
| K131920 | STABILIZATION SCREW | HWC | Substantially Equivalent | |
| K132911 | I.B.S SNAP-OFF SCREW / SOLAFIX SNAP-OFF SCREW | HWC | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3010470577 | 3010470577 | In2Bones SAS | Immeuble Sequoia 3, Saint-Priest Rhone 69800 FR | 2026 | and 22 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- OYKAnkle Arthroplasty Implantation System
- HWJAwl
- HXWBender
- HTWBit, Drill
- GFGBit, Surgical
- GFFBur, Surgical, General & Plastic Surgery
- HXDClamp
- HWRDriver, Prosthesis
- HYAForceps, Wire Holding
- HTJGauge, Depth
- FZXGuide, Surgical, Instrument
- GDZHandle, Scalpel
- HWAImpactor
- HCFInstrument, Ligature Passing And Knot Tying
- HWEInstrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment
- KDDKit, Surgical Instrument, Disposable
- LXHOrthopedic Manual Surgical Instrument
- HTYPin, Fixation, Smooth
- JDWPin, Fixation, Threaded
- HRSPlate, Fixation, Bone
- KILPositioner, Socket
- HSNProsthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer
- HTOReamer
- HSBRod, Fixation, Intramedullary And Accessories
- HWCScrew, Fixation, Bone
- HXXScrewdriver
- HXJStaple Driver
- JDRStaple, Fixation, Bone
- HWDStarter, Bone Screw
- FTYTape, Measuring, Rulers And Calipers
- HWTTemplate
- FSMTray, Surgical, Instrument
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1320-2024 | I.B.S 6.5-C Compression screw - diam 6.5mm lg 80mm,Part Number S65 ST180 | 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. | Class II | Open, Classified | |
| Z-1319-2024 | 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. | Class II | Open, Classified | |
| Z-1283-2021 | 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. | Class II | Terminated | |
| Z-2869-2017 | 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 mm, REF W27 ST016 (f) NEO(R) 0.27 - 18 mm, REF W27 ST018 (f) DRP 0.27 - 18 mm, REF W27 ST018 The NEOVIEW(R) Plating System is intended for fixation of intra-articular and extra-articular fractures of the distal radius and reconstruction of the distal radius. It is composed of a NEOVIEW" plate in PEEK and NE0411 screws in Ti6Al4V that are available in Locking or Non-Locking versions. The NEOVIEW411 Screw Set consists of a standard set of NE0411 screws with different lengths suitable for the implantation of a NEOVIEW9 plate for an average anatomy | The firm received several customer complaints reporting some perioperative breakages of NE0411 Non-Locking screws when inserting the screw into the radius diaphysis | Class II | Terminated | |
| Z-0954-2017 | 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 distal radius | Dimensional non-conformity of the thread on the screw head. | Class II | Terminated | |
| Z-0953-2017 | 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 fractures of the distal radius and reconstruction of the distal radius | Dimensional non-conformity of the thread on the screw head. | Class II | Terminated | |
| Z-0952-2017 | 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 distal radius and reconstruction of the distal radius | Dimensional non-conformity of the thread on the screw head. | Class II | Terminated | |
| Z-0397-2016 | 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. | Class II | Terminated | |
| Z-1319-2015 | DUAFIT(R) PIP 0o CA SIZE 3, REF A60 SP003, STERILE R, Rx only. Interphalangeal implant. | Dimensional non-conformity leading to the impossibility to introduce the implant in the dedicated holder. | Class II | Terminated | |
| Z-1318-2015 | 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. | Class II | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain