Airlock® Ankle Plating System

The Airlock® Ankle Plating System is a titanium alloy implant designed to fix ankle arthrodesis involving the tibiotalocalcaneal and tibiotalar joints, with associated osteotomies of the distal tibia, talus, and calcaneus. The system consists of three plate variants (available in left and right options) and four screw variants (locking polyaxial Ø4 or Ø4.7, and non-locking Ø4 or Ø4.7), with screw lengths from 14 to 60 mm, intended for use in adult patients.

The device is manufactured from TA6V alloy (ASTM F136) and features polyaxial locking, anatomical design, and plate positioning similar to predicates. Key distinguishing features include a short talar neck for anatomical adaptation, visual positioning indicators on the plate to facilitate correct placement, and dedicated tibio-talar screw insertion guidance. The device is provided as a single-use sterile pack ready for clinical use.

Performance testing was conducted per ASTM F382-24 (static four-point bending on plates), ASTM F543-23 (torsional strength, driving torque, and axial pullout on screws), ISO 11137-1/2/3 and ISO 11607-1/2 (sterilization validation), and ISO 10993-1:2018 (biocompatibility assessment).

Substantial equivalence is established because the subject device shares the same intended use, manufacturing material (TA6V alloy), and technological principles with three predicate devices: ORTHOLOC 3DI ANKLE FUSION PLATING SYSTEM (primary), Silverback™ TT/TTC Plating System, and Airlock® osteosynthesis plate systems. The device demonstrated safety and performance conformance to applicable FDA orthopedic guidance documents for fracture fixation plates and metallic bone screws, with no clinical studies required.