implantcast Packaging System Update

This is a packaging system update for multiple previously cleared implantcast orthopaedic devices including hip systems, shoulder replacement systems, and knee systems. The devices themselves (hip prostheses, shoulder prostheses, and knee prostheses) are indicated for total or partial joint replacement in cases of degenerative joint disease, arthritis, fractures, and failed previous arthroplasties. There are no changes to the actual medical devices—only the sterile packaging has been updated.

The new packaging system is the only change being made for all in-scope devices. There are no impacts on the safety or efficacy of each device, and no technological characteristics of the predicate devices are affected by the new packaging system. The devices continue to use the same materials and have the same intended use as their predicates.

The packaging system was validated in accordance with ISO 11607-1 and ISO 11607-2 for sterility assurance. Supplementary sterilization validations were performed for gamma irradiation per ISO 11137-1 and ISO 11137-2, and for ethylene oxide sterilization per ISO 11135.

The subject device and predicate devices have identical intended use, identical technological characteristics, and are made of similar materials. Performance testing demonstrates that the new packaging system is substantially equivalent to the predicate packaging system currently used for implantcast sterile hip, shoulder, and knee systems. Since only the packaging changed and device performance is unaffected, substantial equivalence is established.