Medicon Epiplating System

The Medicon Epiplating System is an implant system consisting of titanium plates and screws designed to anchor external restoration prostheses (such as nose, ear, and eye prostheses) to bone in craniofacial defects when other attachment methods are inadequate. It provides bone anchorage for prosthetic attachment in the maxillo-craniofacial region.

The device uses titanium (pure titanium ASTM F67 or Ti6Al4V alloy ASTM F136) plates and screws with multiple bone fixation points per implant. It operates on the principle of permanent fixation by osseointegration, similar to predicate devices. Key differences from the primary predicate (K161548) include plate design with multiple fixation points versus single implants, and unsterile delivery versus sterile delivery.

ASTM F382 (mechanical testing including proof of load, bending strength, and bending stiffness); ANSI/AAMI/ISO 17665-1:2006/(R)2013 (steam sterilization validation); AAMI TIR30:2011 (cleaning validation); ISO 10993-1 (biocompatibility testing).

The subject device demonstrates substantial equivalence through identical indications for use (attachment of external restoration prostheses in maxillo-craniofacial regions), same material composition (titanium), identical operating principle (osseointegration for permanent fixation), and comparable technological elements to predicate devices. Mechanical testing showed the worst-case implant meets performance standards comparable to reference device K961719, which has the same indications and similar design. Despite design differences (plates versus single implants), the fundamental function, materials, and biocompatibility are substantially equivalent to legally marketed predicates.