Orthofix Galaxy Fixation System
FDA 510(k)Class II (US FDA 510(k))
by Orthofix Srl
Identifiers
- 510(k) Number
- K113770 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 Orthofix Galaxy Fixation System is an orthopedic device designed as a modular platform for building stable external fixation constructs. It uses a wide range of clamps, rods, joint modules, and fixation components to support temporary stabilization to definitive fracture management.
The system is supplied non-sterile and is intended for reusable use. Components marked with the ∆MRX symbol are MR Conditional and must be identified as such prior to placement in or near an MR environment. It received FDA 510(k) clearance (K113770) as substantially equivalent to a predicate device.
Frequently asked questions
What is the Orthofix Galaxy Fixation System used for?
The Orthofix Galaxy Fixation System is designed as a modular platform for building stable external fixation constructs, supporting temporary stabilization through definitive fracture management using a wide range of clamps, rods, joint modules, and fixation components.
Is the Orthofix Galaxy Fixation System sterile or non-sterile, and is it intended for single-use or reuse?
The system is supplied non-sterile and is intended for reusable use, meaning components must be cleaned and sterilized by the user before each application according to validated reprocessing procedures.
What does the ∆MRX symbol indicate on components of the Orthofix Galaxy Fixation System?
Components marked with the ∆MRX symbol are MR Conditional, meaning they have been tested and shown to pose no known hazards in a specified MRI environment under defined conditions, but must be identified as such prior to placement in or near an MR environment.
What regulatory pathway was used for the Orthofix Galaxy Fixation System, and what is its 510(k) number?
The Orthofix Galaxy Fixation System received FDA 510(k) clearance through the traditional pathway as substantially equivalent to a predicate device, with the clearance number K113770 granted on September 4, 2012.
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: Galaxy Fixation - Orthofix, Galaxy Hybrid Fixation - Orthofix, PDF EF_L_Galaxy_E0 X 08-23 - Orthofix, PDF GF-1103-PL-E0 M 12-22.indd - Orthofix
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K113770 | Class II | Active |
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Manufacturer
- Manufacturer
- Orthofix Srl
Sources (1)
- FDA 510(k) K113770 24 fields · synced Sep 25, 2026