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Inion FreedomScrew

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K123672

by Inion Oy

Identifiers

510(k) Number
K123672 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 Inion FreedomScrew is a bone screw designed for orthopedic fixation, classified under the product code HWC. It is intended for use in stabilizing bone fragments or securing orthopedic hardware in skeletal procedures, providing secure attachment and mechanical support during the healing process.

This device is supplied sterile and intended for single-use. It is regulated under the FDA 510K pathway with a clearance type of Traditional, and it complies with the Medical Device Directive (MDD). The FreedomScrew is manufactured by Inion Oy, based in Tampere, Finland, and is distributed with appropriate packaging for surgical use.

Frequently asked questions

What types of surgical procedures is the Inion FreedomScrew intended to support during bone stabilization or hardware attachment?

The Inion FreedomScrew is designed for orthopedic fixation, specifically to stabilize bone fragments or secure orthopedic hardware during skeletal procedures. Its primary role is to provide mechanical support and secure attachment while bones heal, making it suitable for procedures where precise fixation is critical.

Is the Inion FreedomScrew reusable or intended for single-use, and how is it packaged for surgical use?

The Inion FreedomScrew is explicitly intended for single-use only and is supplied sterile in appropriate surgical packaging. This ensures sterility and safety for each procedure, reducing the risk of contamination or cross-infection.

How is the regulatory status of the Inion FreedomScrew determined, and what pathway was followed for FDA clearance?

The Inion FreedomScrew was cleared through the FDA’s 510(k) pathway under a Traditional review process, with a decision classification of Substantially Equivalent (SESE). It also complies with the Medical Device Directive (MDD) in its regulatory framework, ensuring it meets both U.S. and EU standards for orthopedic fixation devices.

What distinguishes the Inion FreedomScrew from other orthopedic screws, particularly in terms of its intended use and mechanical function?

The FreedomScrew is specifically engineered for orthopedic fixation under the product code HWC, meaning it is tailored for stabilizing bone fragments or securing orthopedic hardware during skeletal procedures. Its design prioritizes secure attachment and mechanical support, which is critical for maintaining alignment and facilitating proper healing in orthopedic surgeries.

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
Inion Oy

Sources (2)

  • FDA 510(k) K123672 24 fields · synced Oct 6, 2026
  • EUDAMED 1 fields · synced May 18, 2026