510(k) Report

Devices descending from K021478

338 later devices reach Delta Shoulder through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K243248Inhance Intact™Depuy Ireland UC20240—
+6K241097Arthrex Virtual Implant Positioning (VIP) System SoftwareArthrex, Inc.20240—
+6K233992Precision AI Surgical Planning System (PAI-SPS)Precision AI Pty, Ltd.20242—
+6K231099SMR Hybrid Glenoid SystemLima Corporate S.P.A.20230—
+6K222592AltiVate® Anatomic Shoulder AG e+™ with MarkersEncore Medical L.P.20230—
+6K230904Arthrex Virtual Implant Positioning (VIP) SystemArthrex, Inc.20231—
+6K212560Signature™ ONE SystemOrthosoft Inc (D/B/A Zimmer Cas)20217—
+6K203375OVOMotion Reverse Shoulder Arthroplasty SystemArthrosurface, Inc.20210—
+6K202289ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…Stryker GmbH20202—
+6K200615Signature ONE SystemOrthosoft Inc (D/B/A Zimmer Cas)20208—
+6K192074Signature ONE SystemOrthosoft Inc (D/B/A Zimmer Cas)20199—
+6K182799Arthrex Univers II Shoulder Prosthesis System: Titanium Humeral HeadsArthrex, Inc.20190—
+6K181420Aequalis Flex Revive Shoulder SystemTornier, Inc.20184—
+6K173372ExactechGPS Total Shoulder ApplicationBlue Ortho2017141
+6K162800BLUEPRINT Patient Specific InstrumentationTornier S.A.S.201723—
+7K261510Signature™ ONE SystemOrthosoft Inc. (d/b/a) Zimmer CAS20260—
+7K252352SMR Shoulder System; PRIMA Glenoid System; PRIMA Humeral SystemLima Corporate S.P.A.20260—
+7K243955Precision AI Surgical Planning System (PAI-SPS)Precision AI Pty, Ltd.20251—
+7K241609Tornier Humeral Reconstruction System (Tornier HRS)Stryker Corporation (Tornier, Inc.)20240—
+7K222510Blueprint Mixed Reality systemTornier S.A.S.2023010
+7K213546ExactechGPS Total Shoulder Application, Equinoxe Planning SoftwareBlue Ortho202281
+7K210153NextAR RSA PlatformMedacta International S.A.202151
+7K203315BLUEPRINT™ Patient Specific InstrumentationTornier S.A.S.202118—
+7K191247SmartSPACE Shoulder SystemTechmah Medical, LLC20193—
+7K191318AEQUALIS FLEX REVIVE Shoulder SystemTornier, Inc.201932
+8K251558Precision AI Surgical Planning System (PAI-SPS)Precision AI Pty, Ltd.20260—
+8K252847NextAR Hip PlatformMedacta International S.A.20260—
+8K252841Real Intelligence™ Cori™ XT (Cori XT)Blue Belt Technologies, Inc.20250—
+8K250108OptiVu™ ShoulderMr Surgical Solutions, LLC20251—
+8K241292MyShoulder Planner (5.3SSWPL)Medacta International S.A.20250—
+8K233199ROSA® Shoulder SystemOrthosoft Inc (D/B/A Zimmer Cas)20243—
+8K232521ExactechGPS® Total Ankle ApplicationBlue Ortho20230—
+8K232280NextAR™ TSA PlatformMedacta International S.A.20231—
+8K222405Smart SPACE Shoulder Planner and 3D PositionersLima Corporate S.P.A.20220—
+8K202151Smart SPACE Shoulder SystemTechmah Medical, LLC20211—
+8K202454Smart SPACE Shoulder SystemTechmah Medical, LLC20201—
+9K260582ROSA® Shoulder SystemOrthosoft Inc. (d/b/a) Zimmer CAS20260—
+9K252170OptiVu™ ShoulderMr Surgical Solutions, LLC20250—