I.B.S. 2.0 Osteosynthesis Screw
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
by In2Bones SAS
Identifiers
- 510(k) Number
- K160174 FDA 510(k)
- FDA Product Code
- HWC FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 888.3040 FDA 510(k)
- Regulation Number
- 888.3040 FDA 510(k)
- Advisory Committee
- Orthopedic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The I.B.S. 2.0 Osteosynthesis Screw is a bone fixation device classified under the orthopedic category. It is designed to stabilize and promote healing of long bone fractures by providing secure internal fixation through threaded engagement with cortical bone.
This screw is supplied sterile and intended for single-use in orthopedic surgical procedures. It is regulated under the FDA 510(k) pathway with a clearance type designated as Traditional, and it complies with the Medical Device Directive (MDD) and Medical Device Regulation (MDR). The device is manufactured by In2Bones SAS and is identified by the product code HWC.
Frequently asked questions
What types of bone fractures is the I.B.S. 2.0 Osteosynthesis Screw intended to stabilize, and how does it achieve this?
The I.B.S. 2.0 Osteosynthesis Screw is designed to stabilize and promote healing of long bone fractures by providing secure internal fixation. It achieves this through threaded engagement with cortical bone, ensuring stable alignment during the healing process. This is particularly useful in orthopedic surgeries where maintaining fracture reduction is critical.
Is the I.B.S. 2.0 Osteosynthesis Screw reusable, or is it meant for single-use only? How does this affect its sterility?
The I.B.S. 2.0 Osteosynthesis Screw is explicitly supplied sterile and intended for single-use only. This design ensures patient safety by preventing cross-contamination and maintaining sterility, which is critical in surgical environments where infection control is paramount.
What regulatory pathways does the I.B.S. 2.0 Osteosynthesis Screw follow, and how does this impact its availability?
The I.B.S. 2.0 Osteosynthesis Screw is regulated under the FDA 510(k) pathway with a Traditional clearance, meaning it has been deemed substantially equivalent to a legally marketed predicate device. It also complies with the Medical Device Directive (MDD) and Medical Device Regulation (MDR) in Europe, ensuring its availability in both markets under these regulatory frameworks.
What distinguishes the I.B.S. 2.0 Osteosynthesis Screw from other orthopedic fixation devices, and how is it classified?
The I.B.S. 2.0 Osteosynthesis Screw is classified under the orthopedic category and is specifically designed for internal fixation of long bone fractures. Its classification under FDA product code HWC and its threaded cortical engagement differentiate it from other fixation devices, ensuring precise stabilization for fracture healing.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
MDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| EUDAMED | European Union | MDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K160174 | Class II | Active |
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Manufacturer
- Manufacturer
- In2Bones SAS
Sources (2)
- FDA 510(k) K160174 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced Jun 2, 2026