Paragon 28’s nail system receives 510(k)

March 25, 2020 0 By FM

Paragon 28’s Phantom ActivCore nail system has received 510(k) clearance from the USFDA.

The Phantom ActivCore Nail addresses TTC arthrodesis and is the second of three hindfoot fusion nailing systems Paragon 28 plans to launch in 2020. 

The nail system was designed to include an outer spring sheath and inner sliding core which allows for consistent active compression and up to 8 mm of bone resorption across all joint spaces. 

The nail accommodates two 7.2 mm calcaneal pegs that are inserted from posterior to anterior at a variable (0-18°) angle. These pegs provide fixation distally and work with the inner core feature and tibial pegs to allow for active compression to pass through all joint surfaces.

The system leverages Precision Guide technology allowing for reproducibility when placing a 3.0 mm drill-pin from distal to proximal, through the centre of the calcaneus and up to the tibia.  

The nails were engineered with a flex coil design in the proximal end to provide flexibility as the implant finds its way through the contouring of the tibial canal. All pegs are inserted from posterior to anterior and medial to lateral eliminating the need to take down the fibula.

They are constructed from type II anodised titanium alloy and will be offered in 22 size options with three diameters and four lengths. All distal diameters of the nails are 13.3 mm in diameter with a transition to either; 10.0, 11.5 or 13.0 mm proximally. The distal diameter was increased at the joint spaces to add strength to the implant where it’s needed most. The system will include a comprehensive offering of procedural instrumentation to address joint preparation and restoration of anatomic alignment. The nail is implanted utilising the carbon fibre Phantom Ghost Outrigger. 

Paragon 28 is planning for a full commercial launch in Q2 2020.