Dynex Ring Fixation System, Diametrix Ring Fixation System
FDA 510(k)Class II (US FDA 510(k))
by Vilex, Inc.
Identifiers
- 510(k) Number
- K202054 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 Dynex Ring Fixation System and Diametrix Ring Fixation System are external fixation devices used to stabilize bone fractures, perform arthrodesis, correct deformities, and facilitate limb lengthening. They are used by orthopedic surgeons for various procedures, including stabilization of fractures and osteotomies, rear and midfoot arthrodesis, and correction of bone deformity in upper and lower limbs.
The devices are supplied as part of a comprehensive system and are designed for use in orthopedic procedures. The system has received FDA 510K authorization. The devices are used in a clinical setting and are intended for single-use or reusable applications, depending on the specific procedure and patient needs. The system is available in various sizes and configurations to accommodate different patient requirements.
Frequently asked questions
What is the Dynex Ring Fixation System used for?
The Dynex Ring Fixation System is an external fixation device designed for orthopedic surgeons to stabilize bone fractures, perform arthrodesis (joint fusion), correct deformities, and assist in limb lengthening procedures. It is particularly useful for rear and midfoot arthrodesis as well as upper and lower limb deformity correction.
Is the Dynex Ring Fixation System single-use or reusable?
The Dynex Ring Fixation System can be used for either single-use or reusable applications, depending on the clinical setting, procedure requirements, and patient needs. Reusability is determined by factors such as sterilization protocols and the extent of use in a given case.
What sizes and configurations are available for the Dynex Ring Fixation System?
The system is available in various sizes and configurations to accommodate different patient requirements. These variations ensure adaptability for a range of orthopedic procedures, including fracture stabilization, osteotomies, and deformity correction in both upper and lower limbs.
How is the Dynex Ring Fixation System supplied?
The Dynex Ring Fixation System is supplied as part of a comprehensive orthopedic fixation kit. This ensures all necessary components are available for immediate use in clinical settings, streamlining surgical preparation and execution.
Does the system require any specific regulatory approval?
The Dynex Ring Fixation System has received FDA 510K authorization, confirming its substantial equivalence to a predicate device. This approval ensures it meets regulatory standards for safety and effectiveness in orthopedic 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. Sources consulted: DYNEX® External Fixation System | Vilex, Dynex Ring Fixation System, Diametrix Ring Fixation System, Vilex - DYNEX
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K202054 | Class II | Active |
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Manufacturer
- Manufacturer
- Vilex, Inc.
- FDA Applicant
- Vilex, LLC
Sources (1)
- FDA 510(k) K202054 24 fields · synced Oct 1, 2026