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K Number
K203373
Device Name
Advanced Research Medical Trident SI Screw System
Manufacturer
Advanced Research Medical, LLC
Date Cleared
2021-01-22

(67 days)

Product Code
OUR
Regulation Number
888.3040
Type
Traditional
Panel
OR
Reference & Predicate Devices
K153656
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

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.

Device Description

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.

AI/ML Overview

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.

§ 888.3040 Smooth or threaded metallic bone fixation fastener.

(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.