510(k) Report

Devices descending from K991585

414 later devices reach Bipolar Shoulder Prosthesis through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+9K251558Precision AI Surgical Planning System (PAI-SPS)Precision AI Pty, Ltd.20260—
+9K252847NextAR Hip PlatformMedacta International S.A.20260—
+9K252841Real Intelligence™ Cori™ XT (Cori XT)Blue Belt Technologies, Inc.20250—
+9K250108OptiVu™ ShoulderMr Surgical Solutions, LLC20251—
+9K241292MyShoulder Planner (5.3SSWPL)Medacta International S.A.20250—
+9K233199ROSA® Shoulder SystemOrthosoft Inc (D/B/A Zimmer Cas)20243—
+9K232521ExactechGPS® Total Ankle ApplicationBlue Ortho20230—
+9K232280NextAR™ TSA PlatformMedacta International S.A.20231—
+9K222405Smart SPACE Shoulder Planner and 3D PositionersLima Corporate S.P.A.20220—
+9K202151Smart SPACE Shoulder SystemTechmah Medical, LLC20211—
+9K202454Smart SPACE Shoulder SystemTechmah Medical, LLC20201—
+9K160975Aequalis PerFORM+ Shoulder SystemTornier, Inc.20167—
+10K260582ROSA® Shoulder SystemOrthosoft Inc. (d/b/a) Zimmer CAS20260—
+10K252170OptiVu™ ShoulderMr Surgical Solutions, LLC20250—