510(k) Report

Devices descending from K840643

310 later devices reach Harris-Galante Porous Total Hip Sys through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+9K182502Alteon Acetabular Cup SystemExactech, Inc.201922
+9K172501iNSitu Total Hip SystemTheken Companies, LLC20177—
+9K130634Corin Metafix Hip StemCorin USA20135—
+9K121439Metafix Femoral Hip Stem Size 1Corin USA20128—
+10K250477NextAR (TM) SpineMedacta International S.A.20250—
+10K250108OptiVu™ ShoulderMr Surgical Solutions, LLC20251—
+10K232280NextAR™ TSA PlatformMedacta International S.A.20231—
+10K223769NextAR™ Spine PlatformMedacta International S.A.20232—
+11K252170OptiVu™ ShoulderMr Surgical Solutions, LLC20250—
+11K233172NextAR™ Spine PlatformMedacta International S.A.20241—