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The TIMESH System is intended for use in any oral-maxillo-cranio-facial surgical reconstructive procedure, either orthognathic or trauma, wherein rigid or semirigid internal fixation is utilized as a means of holding bone fragments together. Alternatively, the TIMESH System is also indicated for use in reinforcing weak bony tissues in orthopaedic surgical procedures such as pelvic reconstruction. acetabular reconstruction, and cement restriction. This product is not intended for spinal use.

The TIMESH® System consists of a system of mesh, wire, plates and screws of various sizes and shapes. The implant components are fabricated from Ti-6Al-4V titanium alloy as described by ASTM F-136 or its ISO equivalent. Alternatively, the entire system or parts of it may be made out of commercially pure titanium described by ASTM F-67 or its ISO equivalent. The TIMESH System may be supplied either sterile or non-sterile.

The provided text is a 510(k) summary for the TIMESH® System, a medical device used for bone fixation. It does not contain any information about acceptance criteria, device performance studies, or any of the detailed data requested in the prompt.

The document primarily focuses on:

• Device identification: Company, product name, classification, materials, and intended use.
• Regulatory status: A letter from the FDA stating that the device is substantially equivalent to legally marketed predicate devices.
• Indications for Use: A clear statement of the medical conditions and procedures for which the device is intended.

Since the input document is a regulatory submission summary and not a study report, it inherently lacks the detailed scientific and statistical information required to answer your specific questions about acceptance criteria and device performance studies.

Therefore, I cannot provide the requested table or answer the subsequent questions based on the provided text.

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