510(k) Report

Devices descending from K802123

415 later devices reach Monospherical Shoulder Prosthesis through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+9K150583Aequalis PerFORM+ Shoulder SystemTornier, Inc.201516—
+10K251558Precision AI Surgical Planning System (PAI-SPS)Precision AI Pty, Ltd.20260—
+10K252847NextAR Hip PlatformMedacta International S.A.20260—
+10K252841Real Intelligence™ Cori™ XT (Cori XT)Blue Belt Technologies, Inc.20250—
+10K250108OptiVu™ ShoulderMr Surgical Solutions, LLC20251—
+10K241292MyShoulder Planner (5.3SSWPL)Medacta International S.A.20250—
+10K233199ROSA® Shoulder SystemOrthosoft Inc (D/B/A Zimmer Cas)20243—
+10K232521ExactechGPS® Total Ankle ApplicationBlue Ortho20230—
+10K232280NextAR™ TSA PlatformMedacta International S.A.20231—
+10K222405Smart SPACE Shoulder Planner and 3D PositionersLima Corporate S.P.A.20220—
+10K202151Smart SPACE Shoulder SystemTechmah Medical, LLC20211—
+10K202454Smart SPACE Shoulder SystemTechmah Medical, LLC20201—
+10K160975Aequalis PerFORM+ Shoulder SystemTornier, Inc.20167—
+11K260582ROSA® Shoulder SystemOrthosoft Inc. (d/b/a) Zimmer CAS20260—
+11K252170OptiVu™ ShoulderMr Surgical Solutions, LLC20250—