MEDPOR Customized Implant Kit

The CMF MEDPOR® Customized Implant is a patient-specific craniofacial implant made from porous high-density polyethylene (HDPE), custom-molded to a surgeon's specifications based on CT scans. It is indicated for augmentation and restoration of bony and soft tissue deformities in post-traumatic, post-surgical, or congenital craniofacial defects, including correction and prevention of persistent temporal hollowing.

The subject device shares identical technological characteristics, principles of operation, design specifications, and manufacturing processes with its predicate device. Both are porous HDPE implants sterilized with ethylene oxide, designed to fill bony voids and contour irregularities in non-load-bearing craniofacial regions.

Not stated in this summary. The document references ISO 13485 clauses (7.3 Design controls, 8.3 Nonconforming product, 8.5 Corrective and preventative action) but does not cite specific consensus standards for device testing.

Substantial equivalence is established because the subject device uses identical materials, manufacturing processes, and sterilization methods as the primary predicate (K191916), with no changes to material composition, intended use, or fundamental design. Performance bench testing of the predicate device is valid for the subject device, supplemented by end-user validation lab testing demonstrating compatibility with surgical guides, customized plates, and navigation systems.