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OS2(R)-VP Varisation Staple

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K153770

by In2Bones SAS

Identifiers

510(k) Number
K153770 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(R)-VP Varisation Staple is a surgical staple designed for orthopedic applications, specifically for internal fixation and varisation procedures. It is classified as a bone fixation device, intended to stabilize bone fragments or correct angular deformities through mechanical compression.

This staple is supplied sterile and intended for single-use in orthopedic surgical settings. It is approved under the FDA 510(k) pathway as substantially equivalent to a predicate device, with regulatory compliance also meeting the Medical Device Directive (MDD). The device is available in the specified model variant and adheres to orthopedic fixation standards for bone alignment and stabilization.

Frequently asked questions

What types of orthopedic procedures is the OS2(R)-VP Varisation Staple intended for, and how does it achieve stabilization?

The OS2(R)-VP Varisation Staple is specifically designed for internal fixation and varisation procedures in orthopedic surgery. It stabilizes bone fragments or corrects angular deformities by mechanically compressing the bone, ensuring proper alignment during the healing process. This makes it suitable for scenarios where precise bone realignment and secure fixation are required.

Is the OS2(R)-VP Varisation Staple reusable, or is it meant for single-use only? How is it supplied?

The OS2(R)-VP Varisation Staple is intended for single-use only and is supplied sterile, ensuring safety and compliance with surgical standards. This design minimizes the risk of contamination and cross-infection, which is critical in orthopedic procedures where sterility is paramount.

What regulatory pathways has the OS2(R)-VP Varisation Staple followed, and what does this mean for its use in clinical settings?

The OS2(R)-VP Varisation Staple has been cleared via the FDA 510(k) pathway as *substantially equivalent* to a predicate device, with compliance also meeting the Medical Device Directive (MDD). This means it has undergone rigorous review by the FDA’s Orthopedic (OR) Advisory Committee and is deemed suitable for its intended use in orthopedic fixation procedures, adhering to established safety and performance standards.

How is the device categorized in terms of its regulatory classification, and what does this imply for its application?

The OS2(R)-VP Varisation Staple is classified under the Orthopedic category in the FDA’s regulatory framework, specifically as a bone fixation device. This classification reflects its primary purpose—stabilizing bone fragments or correcting deformities through mechanical compression—ensuring it meets the technical and clinical requirements for orthopedic surgical applications.

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

European Union Active

MDD

United States Active

FDA_510K

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Manufacturer

Manufacturer
In2Bones SAS

Sources (2)

  • FDA 510(k) K153770 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced May 19, 2026