Montblanc Plate System

The Montblanc Plate System is a bone fixation device consisting of plates and screws for internal fixation of fractures and reconstruction in small bones. It includes two variants: the Radius Plate System for distal radius and ulna fractures (supporting palmar, dorsal, or orthogonal application), and the Ankle Plate System for distal tibia and fibula fractures, fusions, osteotomies, and non-unions. The plates are manufactured from CP Grade 4 Titanium and sold as non-sterile, single-use devices.

The subject device is substantially equivalent to predicate devices in indication for use, product code, sterilization method (non-sterile), anatomical site, CP Grade 4 Titanium material, hole dimensions, locking mechanism, screw placement trajectory, and compatible screw sizes. Minor design differences exist in the number of holes, plate width, length and thickness ranges, but these are characterized as slight and do not raise safety or effectiveness concerns. The anodization coating (Type II, AMS 2487) is identical to reference devices K151468, K193616, and K170979.

Testing was conducted per ASTM F382, ASTM F543, and FDA Guidance on Orthopedic Fracture Fixation Plates—Performance Criteria for Safety and Performance Based Pathway (April 11, 2022). Tests included visual inspection, dimensional analysis, and mechanical properties testing (minimum bending strength, bending structural stiffness, torsional strength, driving torque, and axial pullout strength) on worst-case samples.

The Montblanc Plate System shares identical basic design features, intended use, fundamental scientific technology, materials, and non-sterile status with predicate devices K222267 (Arthrex 2.4 mm Volar Distal Radius Plate System) and K123241 (Arthrex Fracture Plates). Although minor geometric variations exist, the applicant argues these differences are slight design refinements that do not raise new safety or effectiveness questions. Performance testing demonstrates the device meets acceptance criteria for mechanical integrity across the intended anatomical applications, supporting substantial equivalence despite the dimensional variations.