Traumafix System, Model TFX.00.00.X

No FDA recalls found in the data synced 22 Oct 2026.

Full name

Sintea Biotech Traumafix System, Model TFX.00.00.X

510(k) Number

K022065 ↗

FDA Product Code

JEC

Device Class

Class II

Regulation

21 CFR Part 888.3040

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

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See all devices from Sintea Biotech, Inc. →

• Is the Traumafix System reusable or single-use, and what does this mean for my hospital’s workflow?

  The Traumafix System is designed as a reusable device, meaning its metallic components are intended for repeated use across multiple patients after proper cleaning, sterilization, and maintenance. This makes it suitable for clinical or hospital settings where infection control and cost efficiency are priorities. However, hospitals must follow strict reprocessing protocols to ensure sterility and functionality between uses, as no specific sterility guarantees are provided in the available data.

• What types of orthopedic procedures is the Traumafix System primarily used for, and how does it stabilize fractures?

  The Traumafix System is specifically designed for external circular traction, providing mechanical fixation to bone through Schanz screws and metallic components. It is used for fracture management, limb lengthening, and reconstruction procedures by applying controlled traction to stabilize bone alignment. The system’s circular design allows for multi-directional stabilization, which is critical for complex orthopedic cases requiring precise alignment and gradual correction.

• Are there different sizes or models available for the Traumafix System, and how do I determine the right fit for a patient?

  The Traumafix System is available in multiple configurations under the TFX.00.00.X model series, though specific size variations (e.g., screw diameters, ring diameters, or frame sizes) are not detailed in the provided data. Selection typically depends on the patient’s anatomy, the type of procedure, and the surgeon’s assessment of the required traction force. Clinicians should consult the manufacturer’s technical documentation or a Sintea Biotech representative to match the appropriate components to the patient’s needs.

• How was the Traumafix System’s safety and equivalence to prior devices evaluated by the FDA, and what does the ‘Traditional 510(k)’ pathway mean?

  The Traumafix System received FDA 510(k) clearance under the Traditional pathway, meaning its safety and performance were compared to legally marketed predicate devices (those already cleared for similar uses) to demonstrate substantial equivalence. The FDA classified it as a Class II device under regulation 888.3040, indicating it poses moderate risk and requires special controls beyond general controls. The clearance was granted in 2002, and the system is intended for use by orthopedic surgeons in clinical settings.

• Does the Traumafix System have any limitations regarding MRI compatibility or special handling requirements?

  The available data does not specify MRI safety information for the Traumafix System, meaning its compatibility with MRI machines (e.g., whether metallic components could cause artifacts or pose risks) is not addressed. Clinicians should verify compatibility with their MRI equipment and consult the manufacturer before using the system in an MRI environment. Additionally, since it is a reusable device, proper cleaning and sterilization protocols must be followed to prevent cross-contamination.