In2bones Sas
Medical device manufacturer in Ecully, FR.
18510(k) clearances
0PMA approvals
10recalls
Device types
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K231699 | QUANTUM® Patient Specific Instrumentation (PSI) SystemHSN · Traditional | 04/23/2024SE |
| K230313 | QUANTUM Patient Specific Instrumentation (PSI) SystemHSN · Traditional | 04/06/2023SE |
| K211883 | QUANTUM® Patient Specific Instrumentation (PSI) SystemHSN · Traditional | 08/11/2021SE |
| K191380 | Quantum® Total Ankle ProsthesisHSN · Traditional | 01/29/2020SE |
| K173811 | TRIWAY Tibiotalocalcaneal (TTC) Arthrodesis SystemHSB · Traditional | 03/15/2018SE |
| K173616 | DIP Arthrodesis SystemHTY · Traditional | 01/19/2018SE |
| K173121 | Ankle Fusion Plating SystemHRS · Traditional | 11/28/2017SE |
| K170688 | PITStop® implantHWC · Traditional | 11/28/2017SE |
| K170594 | I.B.S. osteosynthesis screwsHWC · Special | 05/10/2017SE |
| K160174 | I.B.S. 2.0 Osteosynthesis screwHWC · Traditional | 10/06/2016SE |
| K160995 | NEOVIEW Plating SystemHRS · Traditional | 06/10/2016SE |
| K153770 | OS2(R)-VP Varisation StapleJDR · Traditional | 03/21/2016SE |
| K153395 | OS2-C Compression StapleJDR · Traditional | 02/18/2016SE |
| K153204 | In2Bones Kirschner wireHTY · Traditional | 02/01/2016SE |
| K143323 | OS2-V Varisation StapleJDR · Traditional | 02/26/2015SE |
| K132912 | Duafit Intergphalangeal Implant, Peek-Fuse Interphalangeal ImplantHWC · Traditional | 07/30/2014SE |
| K131920 | Stabilization ScrewHWC · Traditional | 05/01/2014SE |
| K132911 | I.B.S Snap-Off Screw / Solafix Snap-Off ScrewHWC · Traditional | 04/04/2014SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-1320-2024 Class II | I.B.S 6.5-C Compression screw - diam 6.5mm lg 80mm,Part Number S65 ST180This Field Action is being conducted following the identification of a batch mix-up between I.B.S… | 01/26/2024Open, Classified |
| Z-1319-2024 Class II | I.B.S 6.5-C Compression screw - diam 6.5mm lg 75mm,Part Number S65 ST175This Field Action is being conducted following the identification of a batch mix-up between I.B.S… | 01/26/2024Open, Classified |
| Z-1283-2021 Class II | In2Bones Shannon Percutaneous Burr - Product Usage: indicated for forefoot mini-invasive…This Field Action is being conducted following identification of manufacturing non-conformity of some… | 02/09/2021Terminated |
| Z-2869-2017 Class II | Non-Locking screws in the following lengths: (a) NEO(R) 0.27 - 10 mm, REF W27 ST010 (b)…The firm received several customer complaints reporting some perioperative breakages of NE0411 Non-Locking… | 07/13/2017Terminated |
| Z-0954-2017 Class II | NEOVIEW(R) SCREWS SET, REF W27 ST900, STERILE R The NEOVIEW Plating System is intended…Dimensional non-conformity of the thread on the screw head. | 12/19/2016Terminated |
| Z-0953-2017 Class II | NEO SCREW 02.7-14MM LOCKING, REF W27 ST114, In2Bones, 28 chemin du petit bois, 69130…Dimensional non-conformity of the thread on the screw head. | 12/19/2016Terminated |
| Z-0952-2017 Class II | SCREW 02.7-12MM LOCKING, REF W27 ST112: a) DRP, b) NEO, In2Bones, 28 chemin du petit…Dimensional non-conformity of the thread on the screw head. | 12/19/2016Terminated |
| Z-0397-2016 Class II | 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. | 11/18/2015Terminated |
| Z-1319-2015 Class II | 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. | 03/09/2015Terminated |
| Z-1318-2015 Class II | 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. | 03/09/2015Terminated |