In2Bones SAS
Active in EUDAMEDFrancefrom SRN EUDAMED FDA SRN FR-MF-000005246 FEI 3010470577
In2Bones SAS is a medical device manufacturer based in France, with 319 devices listed in EUDAMED, FDA GUDID and FDA 510(k) (EU Class IIa, IIb and I; FDA Class II) and 10 FDA recalls as of 14 Nov 2026.
- Devices
- 319
- Registrations
- EUDAMEDFDA
- FDA recalls
- 102 ongoing
Registry facts
- Registries
- EUDAMED 302
- FDA GUDID 302
- FDA 510(k) 17
- Device classes
- EU Class IIa 124
- EU Class IIb 107
- EU Class I 71
- FDA Class II 17
- Top EMDN categories
- FDA recalls
- Identifiers
- EUDAMED SRN FR-MF-000005246
- FDA FEI 3010470577
At a glance
Market reach
- European Union
- EUDAMED actor
- United States
- FDA establishment, FDA recalls
What In2Bones SAS makes
In2Bones SAS manufactures orthopaedic instruments and fixation devices, including single-use joint prosthesis implantation kits, non-bioabsorbable orthopaedic bone pins, and orthopaedic fixation plates. Their product line also covers wire holding/twisting forceps and patient-specific instrumentation systems for surgical precision. Examples include Kirschner wires, the NEOFIT® and NEOFUSE systems, and the IBS™ and NEOSYS devices.
The company’s devices are classified under EU regulations as Class I, Class II, Class IIa, and Class IIb, with corresponding listings in the EUDAMED registry and FDA’s 510(k) database. Their portfolio is regulated under French and European medical device directives, ensuring compliance with both local and international standards. The manufacturer is based in France.
Catalogue
Search and filter all 319 devicesShowing 1-50 of 319
Company details
- EUDAMED SRN
- FR-MF-000005246
- FDA FEI number
- 3010470577
- EU VAT number
- FR 365 37843377
- EUDAMED status
- Active
- EUDAMED registered name
- In2Bones SAS
- Registered address
- 97, Allée Alexandre Borodine, 69800, Saint Priest, France
- PRRC contact
- Martin GEERTSEMA
FDA recalls
FDA recall records list 10 recalls initiated by In2Bones SAS, the earliest on 2015-03-09 and the most recent on 2024-01-26. By recorded status: 2 ongoing and 8 terminated. The reasons filed fall into these groups: mechanical integrity and manufacturing or quality process. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
Recalls initiated per year
- 2017 1
- 2018 0
- 2019 0
- 2020 0
- 2021 1
- 2022 0
- 2023 0
- 2024 2
- 2025 0
- 2026 0
2024
- 26 Jan 2024 Z-1319-2024 Class II Ongoing 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.
- 26 Jan 2024 Z-1320-2024 Class II Ongoing 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.
2021
- 9 Feb 2021 Z-1283-2021 Class II Terminated 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.
2017
- 13 Jul 2017 Z-2869-2017 Class II Terminated The firm received several customer complaints reporting some perioperative breakages of NE0411 Non-Locking screws when inserting the screw into the radius diaphysis
2016
- 19 Dec 2016 Z-0952-2017 Class II Terminated Dimensional non-conformity of the thread on the screw head.
- 19 Dec 2016 Z-0953-2017 Class II Terminated Dimensional non-conformity of the thread on the screw head.
- 19 Dec 2016 Z-0954-2017 Class II Terminated Dimensional non-conformity of the thread on the screw head.
2015
- 18 Nov 2015 Z-0397-2016 Class II Terminated One batch of osteosynthesis screws were manufactured with the incorrect Torx imprint on the screw head.
- 9 Mar 2015 Z-1318-2015 Class II Terminated Dimensional non-conformity leading to the impossibility to introduce the implant in the dedicated holder.
- 9 Mar 2015 Z-1319-2015 Class II Terminated Dimensional non-conformity leading to the impossibility to introduce the implant in the dedicated holder.
FDA establishments
- IN2BONES US
Frequently asked questions
How many devices does In2Bones SAS have in the registry?
The registry currently lists 319 devices for In2Bones SAS. Devices recorded under merged duplicate company entries are counted once.
Which registries list In2Bones SAS's devices?
Among its 50 most recently registered devices, In2Bones SAS has devices listed in EUDAMED (33 devices), FDA 510(k) (17 devices) and FDA GUDID (33 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do In2Bones SAS's devices fall under?
Among its 50 most recently registered devices, the classes recorded for In2Bones SAS's devices are Class I, Class IIa, Class IIb and Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for In2Bones SAS?
FDA recall records list 10 recalls initiated by In2Bones SAS, the most recent initiated on 26 Jan 2024. 2 of them are recorded as ongoing. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from In2Bones SAS in the registry?
The most recently registered devices listed for In2Bones SAS include NEOFIT®, NEOFUSE, IBS™ and Kirschner wire.
Which FDA establishments are linked to In2Bones SAS?
1 FDA establishment is linked to In2Bones SAS in the registry; they are listed on the company page.