Resolve Anterior Cervical Plate System

The Resolve Anterior Cervical Plate System is a spinal fixation device used for anterior cervical fusion of the cervical spine (C2-C7) in skeletally mature patients. It consists of non-sterile, single-use titanium alloy (Ti-6Al-4V) plates with an integrated active locking mechanism and accompanying screws, designed to treat conditions including degenerative disc disease, trauma, stenosis, deformities, tumors, pseudoarthrosis, and failed previous fusion.

The device is manufactured from titanium alloy (Ti-6Al-4V) with an integrated active locking mechanism, offered in various lengths, and accommodates constrained and variable screw positioning. It includes non-sterile, reusable instruments for implantation and explantation.

Static compression bending per ASTM F1717, static torsion testing per ASTM F1717, dynamic compression bending per ASTM F1717, MR Safety analysis and testing per ASTM F2052, ASTM F2213, and ASTM F2182 for MR Conditional Labeling. Testing was also performed according to the FDA guidance document 'Spinal Plating Systems – Performance Criteria for Safety and Performance Based Pathway.'

The Resolve system meets or exceeds acceptance criteria established in FDA guidance for spinal plating systems and demonstrates performance equivalent to the predicate CervAlign Anterior Cervical Plate System. Mechanical testing (static compression bending, static torsion, and dynamic compression bending) confirms the worst-case configuration is as safe and effective as previously cleared systems. The device's technological characteristics—titanium alloy construction, active locking mechanism, and MR conditional compatibility—are substantially equivalent to the predicate, with the primary difference being the addition of target population specification in indications for use.