SixFix Hexapod Fixator Accessories
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K200123 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 SixFix Hexapod Fixator Accessories are classified as an Appliance, Fixation, Nail/Blade/Plate under FDA classification 888.3030. This device consists of components designed to complement the SixFix Hexapod Fixator, a multilateral circular external fixation system. It includes rings, arches, struts, threaded rods, reduction struts, and assembly accessories to facilitate orthopedic stabilization, distraction, and deformity correction. The system operates as a mechanical fixation device, providing structural support for bone segments during treatment.
These accessories are intended for use in clinical settings by orthopedic surgeons and are supplied as part of the SixFix Hexapod Fixator system. The device is FDA-cleared under 510(k) K200123, with a Substantially Equivalent (SESE) determination. While the specific sterility or single-use/reusable status is not detailed, the components are designed for surgical use in orthopedic procedures. No additional regulatory markings (e.g., MRI safety) are provided in the available data.
Frequently asked questions
What are the SixFix Hexapod Fixator Accessories used for?
These accessories are designed to complement the SixFix Hexapod Fixator, a multilateral circular external fixation system. They provide structural support for bone segments during orthopedic procedures, enabling stabilization, distraction, and correction of deformities. The components—such as rings, arches, struts, threaded rods, and reduction struts—work together to facilitate precise mechanical fixation in clinical settings.
Are these accessories supplied as part of the SixFix Hexapod Fixator system?
Yes, the accessories are intended to be used alongside the SixFix Hexapod Fixator system. They are not standalone devices but rather complementary components that enhance the functionality of the fixator for orthopedic stabilization purposes.
What is the sterility and single-use/reuse status of these accessories?
The provided data does not specify whether these accessories are sterile or intended for single-use or reuse. However, as surgical components, they are designed for clinical use in orthopedic procedures, so proper sterilization protocols should be followed if reuse is intended. Always verify sterility status with the manufacturer before use.
Are there different sizes or models available for these accessories?
The data does not detail specific sizes or model variations for the accessories beyond their general classification as part of the SixFix Hexapod Fixator system. The system includes rings, arches, struts, threaded rods, and reduction struts, but exact dimensions or model references would require consulting the manufacturer’s technical documentation or catalog.
How should these accessories be stored?
Since the accessories are intended for surgical use, they should be stored in a clean, dry environment to prevent contamination. If sterile packaging is provided, it should remain intact until use. For reusable components, follow the manufacturer’s guidelines for cleaning, disinfection, and storage to maintain sterility and functionality.
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: Accessories for the SixFix® Hexapod Fixator (K200123) — FDA 510 (k ..., K200123 - Accessories for the SixFix® Hexapod Fixator, Accessories For The SixFix® Hexapod Fixator 510(k)… - FDA.report
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K200123 | Class II | Active |
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Manufacturer
- Manufacturer
- Arrowhead De Llc
- FDA Applicant
- Arrowhead De, LLC
Sources (1)
- FDA 510(k) K200123 24 fields · synced Oct 1, 2026