MAXXOS P.A.C.E. Foot & Ankle Plating System

The MAXXOS P.A.C.E. Foot & Ankle Plating System is a metallic bone fixation device consisting of titanium plates and screws in three subsystems: Forefoot (for small bones like phalanges and metatarsals), Mid/Hindfoot (for larger foot bones like talus and calcaneus), and Ankle Fracture/Fusion (for distal tibia and fibula). The device is indicated for stabilization of fractures, joint fusions, osteotomies, nonunions, malunions, and reconstruction in adult patients.

The MAXXOS system uses identical materials (Ti-6Al-4V ELI per ASTM F136 or CP Ti) with Anodized Type II surface treatment as the predicate. It comprises locking and standard cortical screws in 2.0mm to 4.0mm sizes with various plate geometries (straight, T-shaped, L-shaped, cloverleaf, etc.). The primary difference is the addition of ankle fusion plates to the Ankle Fracture and Fusion System, supported by engineering justification. All ancillary instrumentation is standard and not system-specific.

4 Point Bending Static and Dynamic testing per ASTM F382-17; Cantilever Construct Static and Fatigue testing per ASTM F382-17; MRI testing including Magnetically Induced Displacement Force (ASTM F2052), Magnetically Induced Torque (ASTM F2213), MR Image Artifact (ASTM F2119), and Radio Frequency Induced Heating (ASTM F2182).

The MAXXOS system is substantially equivalent because it has identical indications for use, identical design, and is made of identical materials with identical anatomic mechanical properties as the predicate BioPro Foot Plating System. Test results demonstrate no new worst-case scenarios were introduced. The only modification—addition of ankle fusion plates—is supported by engineering justification and does not create new safety or performance concerns compared to the predicate.