Search Results

The Advanced Research Medical Trident SI Screw System is intended for fusion of the sacroiliac joint for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.

The Advanced Research Medical Trident SI Screw System consists of screws manufactured from Ti-6Al-4V ELI per ASTM F136. The screws are available in a variety of lengths and diameters to accommodate varying patient anatomy.

This document is an FDA 510(k) clearance letter for a medical device called the "Advanced Research Medical Trident SI Screw System." It explicitly states that clinical testing was not required for this device. Therefore, the document does not contain information about acceptance criteria for device performance, a study to prove it meets them, sample sizes, ground truth establishment, or expert involvement in such a study.

The FDA's determination of "substantial equivalence" for this device was based on:

• Comparison of mechanical testing results: Static and dynamic cantilever bending per ASTM F2193, and axial pullout, driving torque, and torsional strength per F543.
• Indications and intended uses: Identical to the predicate device.
• Device function: Identical to the predicate device.
• Material: Same as the predicate device (Ti-6Al-4V ELI per ASTM F136), which is recognized by the FDA and cleared for implantation.
• Cleaning and sterilization protocols: Validated cleaning procedure and steam sterilization protocol.

Since no clinical study was conducted as part of this 510(k) submission, the requested information cannot be extracted from the provided text.

Ask a specific question about this device