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Dyna-Extor Ii

FDA 510(k)

Class II (US FDA 510(k))

510(k) K110426

by Bk Meditech Co., Ltd.

Identifiers

510(k) Number
K110426 FDA 510(k)
FDA Product Code
KTT 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 Dyna-Extor II External Fixation System is a device classified under the External Fixation Device category, designed for the stabilization of long bone fractures or deformities. It employs modular components, including clamps, bars, and connectors, to provide external skeletal support and facilitate bone alignment or lengthening. The system is engineered to offer adjustable fixation, accommodating various clinical scenarios such as trauma, deformity correction, or post-surgical stabilization. Its modular design allows for customization based on anatomical requirements and procedural needs.

The Dyna-Extor II is supplied as a reusable medical device, intended for use in orthopedic surgical settings. It includes a free-type clamp, lengthening bar, simple bar, single clamp, bar-ring connector, and optional accessories, all of which are assembled per clinical indication. The system is not classified as single-use and requires proper sterilization between procedures. Its modular components are compatible with MRI environments, though specific safety considerations should be reviewed per facility protocols. The device holds FDA 510(k) clearance (K110426) under the Traditional 510(k) pathway, with a decision date of November 2, 2011.

Frequently asked questions

What is the Dyna-Extor II External Fixation System used for?

The Dyna-Extor II is designed for the stabilization of long bone fractures or deformities, as well as post-surgical support. Its modular components—such as clamps, bars, and connectors—allow clinicians to customize fixation for trauma cases, deformity correction, or alignment adjustments during bone lengthening procedures. The system’s adjustable design ensures adaptability to various anatomical and procedural needs.

Is the Dyna-Extor II a single-use or reusable device?

The Dyna-Extor II is a reusable medical device. It is intended for repeated use in orthopedic settings, provided it undergoes proper sterilization between procedures. This design reduces waste and cost while maintaining clinical performance.

What components are included in the Dyna-Extor II system?

The system includes a free-type clamp, lengthening bar, simple bar, single clamp, bar-ring connector, and optional accessories. These modular parts are assembled according to the specific clinical indication, allowing flexibility for different surgical requirements.

Can the Dyna-Extor II be used in MRI environments?

Yes, the modular components of the Dyna-Extor II are compatible with MRI environments. However, facilities should review their own MRI safety protocols to ensure proper use, as individual settings may have specific considerations for external fixation devices.

How is the Dyna-Extor II sterilized between uses?

Since the Dyna-Extor II is reusable, it must be sterilized between procedures to maintain hygiene and prevent infection. The manufacturer recommends following standard sterilization protocols for orthopedic devices, such as autoclaving or chemical sterilization, to ensure all components are properly disinfected before reuse.

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: BK MEDITECH CO.,LTD. 27100 Dyna-EXTOR Ⅱ EXTERNAL FIXATION SYSTEM, BK MEDITECH CO.,LTD. 25300 Dyna-EXTOR Ⅱ EXTERNAL FIXATION SYSTEM, BK MEDITECH - Epart

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Bk Meditech Co., Ltd.
FDA Applicant
Bk Meditech, Co., Ltd.

Sources (1)

  • FDA 510(k) K110426 24 fields · synced Oct 1, 2026