OS2-V Varisation Staple
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
by In2Bones SAS
Identifiers
- 510(k) Number
- K143323 FDA 510(k)
- FDA Product Code
- JDR FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 888.3030 FDA 510(k)
- Regulation Number
- 888.3030 FDA 510(k)
- Advisory Committee
- Orthopedic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The OS2-V Varisation Staple is a surgical fixation device classified as an orthopedic staple, designed for use in Akin type osteotomies. It provides internal fixation to stabilize bone fragments during corrective procedures, ensuring proper alignment and varus angulation.
This device is supplied sterile, pre-loaded onto its inserter, and includes a drill guide packaged with the implant. Available in interaxis sizes of 8 mm or 10 mm with angles of 26° or 90°, it is intended for single-use applications. The OS2-V Varisation Staple holds FDA 510(k) clearance under the Medical Devices Directive (MDD) and is intended for use with single-use instruments.
Frequently asked questions
What types of bone procedures is the OS2-V Varisation Staple specifically designed for, and how does it help during surgery?
The OS2-V Varisation Staple is designed specifically for Akin type osteotomies, a procedure used to correct deformities in the knee or foot. It provides internal fixation to stabilize bone fragments, ensuring proper alignment and varus angulation—critical for achieving the desired surgical outcome. By holding the bone fragments securely, it helps maintain stability during the healing process.
Is the OS2-V Varisation Staple reusable, or is it intended for single-use only? How does this affect its packaging?
The OS2-V Varisation Staple is explicitly intended for single-use only, as stated in the device description. This means it is supplied sterile, pre-loaded onto its inserter, and packaged with a drill guide to ensure proper use in one surgical procedure. Single-use design eliminates the need for reprocessing and reduces infection risks.
What sizes and angles are available for the OS2-V Varisation Staple, and how might this affect my choice for a patient?
The OS2-V Varisation Staple comes in two interaxis sizes: 8 mm or 10 mm, and two angle options: 26° or 90°. The choice depends on the specific anatomical requirements of the procedure—smaller sizes or angles may be preferred for delicate or precise corrections, while larger sizes offer broader stability for more substantial bone fragments.
How is the OS2-V Varisation Staple supplied, and what tools are included to ensure proper surgical use?
The device is supplied sterile, pre-loaded onto its dedicated inserter, along with a drill guide to assist in accurate placement during surgery. This packaging ensures readiness for immediate use while maintaining sterility, reducing setup time in the operating room.
What regulatory pathway was followed for FDA clearance of the OS2-V Varisation Staple, and what does this mean for its use in the U.S.?
The OS2-V Varisation Staple received FDA 510(k) clearance under the Medical Devices Directive (MDD) via a Traditional 510(k) pathway, classified as substantially equivalent to a predicate device. This means it has undergone review by the FDA’s Orthopedic (OR) Advisory Committee and is legally marketable in the U.S. for its intended use in Akin osteotomies, adhering to safety and performance standards.
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. Sources consulted: PDF OS2 V OS2 VP - in2bones, PDF ST-DIG-OS2V-EN-092020.indd - bmgorthopaedics.com, PDF Koren® - Ancre de fixation - in2bones.com, PDF Koren® - Ancre de fixation - in2bones.com
Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K143323 | Class II | Active |
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Manufacturer
- Manufacturer
- In2Bones SAS
Sources (2)
- FDA 510(k) K143323 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 19, 2026