510(k) Report

Devices descending from K992119

419 later devices reach Bio-Modular Shoulder System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K222510Blueprint Mixed Reality systemTornier S.A.S.2023010
+8K213546ExactechGPS Total Shoulder Application, Equinoxe Planning SoftwareBlue Ortho202281
+8K210153NextAR RSA PlatformMedacta International S.A.202151
+8K203315BLUEPRINT™ Patient Specific InstrumentationTornier S.A.S.202118—
+8K191247SmartSPACE Shoulder SystemTechmah Medical, LLC20193—
+8K191318AEQUALIS FLEX REVIVE Shoulder SystemTornier, Inc.201932
+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—
+10K260582ROSA® Shoulder SystemOrthosoft Inc. (d/b/a) Zimmer CAS20260—
+10K252170OptiVu™ ShoulderMr Surgical Solutions, LLC20250—