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Traufix osteosynthesis, osteotomy, and arthrodesis devices

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K201510

by Fixier S.A. DE C.V.

Identifiers

510(k) Number
K201510 FDA 510(k)
FDA Product Code
HRS 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 Traufix Osteosynthesis, Osteotomy, and Arthrodesis Devices are metallic bone fixation implants classified under the FDA product code HRS. These devices include plates and screws designed to stabilize bone fragments during fracture treatment, osteotomies, and arthrodesis procedures, ensuring proper alignment and consolidation of bone structures.

These devices are intended for use in clinical settings by orthopedic surgeons. The 3.5mm One-third Tubular Plate with 8 holes is a reusable, non-sterile implant supplied in a sterile packaging for surgical use. The device is authorized under FDA 510K clearance (K201510) and the Medical Devices Directive (MDD), adhering to regulatory standards for orthopedic fixation hardware. Storage and handling follow standard surgical instrument protocols.

Frequently asked questions

What types of bone procedures are these devices specifically designed for, and how do they function in those cases?

The Traufix devices are designed for osteosynthesis (fixing fractures), osteotomies (controlled bone cuts for realignment), and arthrodesis (fusion of joints). They use metallic plates and screws to stabilize bone fragments, ensuring proper alignment and promoting bone consolidation during healing. The 3.5mm One-third Tubular Plate with 8 holes is particularly suited for mid-shaft fractures or surgical corrections where secure fixation is required.

Are these devices reusable, or are they intended for single-use in surgery?

The 3.5mm One-third Tubular Plate is explicitly labeled as reusable, though it is supplied in sterile packaging for surgical use. This means it can be cleaned, sterilized, and reused per standard surgical instrument protocols, provided proper reprocessing is followed. Always verify reprocessing guidelines before reuse to ensure safety and compliance.

How should these devices be stored, and what precautions should be taken to maintain their integrity?

Storage follows standard protocols for surgical instruments. The devices should be kept in their sterile packaging until ready for use, protected from moisture, dust, and physical damage. If reusable, they must be cleaned and sterilized according to established medical device reprocessing standards (e.g., autoclave or chemical sterilization) before reuse. Avoid exposure to extreme temperatures or contaminants that could compromise sterility or structural integrity.

What regulatory pathways have these devices undergone, and which governing bodies have authorized their use?

The Traufix devices are authorized under FDA 510(k) clearance (K201510) and comply with the Medical Devices Directive (MDD) in the EU. The FDA classified them under product code HRS (Orthopedic Devices) and determined them substantially equivalent to a predicate device. These clearances confirm their compliance with safety and performance standards for orthopedic fixation hardware, ensuring they meet regulatory requirements for clinical use.

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: Traufix osteosynthesis, osteotomy, and arthrodesis devices, Traufix osteosynthesis, osteotomy, and arthrodesis devices, Traufix osteosynthesis, osteotomy, and arthrodesis devices, Traufix Osteosynthesis, Osteotomy, And Arthrodesis… - FDA.report

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDD

United States Active

FDA_510K

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Manufacturer

Manufacturer
Fixier S.A. DE C.V.

Sources (2)

  • FDA 510(k) K201510 24 fields · synced Sep 20, 2026
  • EUDAMED 1 fields · synced May 18, 2026