Coated hip implants

Coated hip implants are prosthetic devices designed for total hip arthroplasty (replacement) in primary or revision surgery. They are indicated for patients with severe joint pain or disability due to osteoarthritis, avascular necrosis, traumatic fracture, or failure of previous hip surgery. The devices come in multiple product lines (Versafitcup CC Trio, Quadra-P, AMIStem, MiniMAX, SMS, Mpres, and Mpact) with either cementless or cemented fixation.

The devices use titanium alloy substrates (Ti-6Al-4V or Ti-6Al-7Nb) with surface coatings of titanium, hydroxyapatite, or porous titanium. The only modification in this submission is the addition of a new supplier to perform the coating process; all design features, substrate materials, dimensional characteristics, principle of operation, indications for use, biocompatibility, packaging, shelf life, and sterility remain unchanged.

ISO 13179-1, ISO 13779-2, ISO 13779-3, ISO 13779-4, ASTM F1854, ASTM F1147, ASTM F1609, ASTM F1044, ASTM F1160, ASTM F1978, ISO 21920-3, ASTM F3090-20, ISO 19227, ISO 10993 series, ISO 11607-1, and ISO 11607-2.

The devices coated by the new supplier are substantially equivalent because only the coating supplier has changed, not the device design, materials, dimensions, intended use, or performance characteristics. Testing demonstrates that coatings from the new supplier meet the same acceptance criteria and specifications as coatings from the current supplier across composition, mechanical properties, morphology, and biocompatibility. Since the devices perform identically to their predicate equivalents and undergo the same clinical validation pathways, switching coating suppliers does not create new safety or effectiveness concerns.