510(k) Report

Devices descending from K980711

309 later devices reach Harris/Galante Porous (HGP) Hip Prosthesis with Calcicoat Ceramic Coating through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K172501iNSitu Total Hip SystemTheken Companies, LLC20177—
+8K130634Corin Metafix Hip StemCorin USA20135—
+8K121439Metafix Femoral Hip Stem Size 1Corin USA20128—
+9K250477NextAR (TM) SpineMedacta International S.A.20250—
+9K250108OptiVu™ ShoulderMr Surgical Solutions, LLC20251—
+9K232280NextAR™ TSA PlatformMedacta International S.A.20231—
+9K223769NextAR™ Spine PlatformMedacta International S.A.20232—
+10K252170OptiVu™ ShoulderMr Surgical Solutions, LLC20250—
+10K233172NextAR™ Spine PlatformMedacta International S.A.20241—