ONVOY™ Acetabular System

The ONVOY Acetabular System is a hip prosthesis component used to reconstruct the hip socket (acetabular portion) in patients with severe hip disease or pain from osteoarthritis, rheumatoid arthritis, fractures, or failed previous hip replacements. It consists of acetabular shells, liners, dual mobility components, and femoral heads available in various sizes and configurations for cementless fixation.

The ONVOY shells are additively manufactured from titanium alloy powder (differing from predicate manufacturing methods), while liners and dual mobility bearings are made from highly crosslinked UHMWPE with Vitamin E, and dual mobility liners from cobalt-chrome alloy. Key similarities to predicates include design features (locking mechanism, material thickness, bearing diameter), intended use, function, and available size ranges, though the subject devices differ in shell manufacturing method and polyethylene crosslinking radiation dose.

Testing performed per ASTM F3090, ASTM F1820, ASTM F1875, ASTM F2345, ASTM F2582, ISO 7206-12, ISO 14242, ISO 21535, and ANSI/AAMI ST72:2011, covering mechanical testing (fatigue, disassembly, wear, impingement, fretting and corrosion), range of motion assessment, and bacterial endotoxin testing.

The subject ONVOY implants demonstrate substantial equivalence because they maintain the same technological characteristics, function, and indications for use as predicate devices despite differences in manufacturing method (additive manufacturing for shells) and crosslinking radiation dose. Performance data from comprehensive mechanical and biocompatibility testing show these manufacturing differences do not raise new safety or effectiveness concerns, and the devices achieve equivalent performance outcomes to predicate devices across all evaluated parameters.