510(k) Report

Devices descending from K111902

49 later devices reach Aequalis Shoulder System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K260721Tornier Perform Advanced GlenoidTornier, Inc.20260—
+1K150583Aequalis PerFORM+ Shoulder SystemTornier, Inc.201516—
+1K143374BLUEPRINT Patient Specific InstrumentationTornier S.A.S.201531—
+2K190738MyShoulder Placement GuidesMedacta International S.A.20194—
+2K173812Catalyst CSR 3 Peg GlenoidsCatalyst Orthoscience, Inc.20181—
+2K161789BLUEPRINT Patient Specific InstrumentationTornier S.A.S.20160—
+2K160555BLUEPRINT Patient Specific InstrumentationTornier S.A.S.201625—
+2K160975Aequalis PerFORM+ Shoulder SystemTornier, Inc.20167—
+2K152825Catalyst CSR Shoulder SystemCatalyst Orthoscience, LLC20167—
+3K243509Archer PSI System3D-Side20250—
+3K233992Precision AI Surgical Planning System (PAI-SPS)Precision AI Pty, Ltd.20242—
+3K220847AETOS Shoulder SystemSmith & Nephew, Inc.20235—
+3K191811Catalyst OrthoScience CSR Shoulder SystemCatalyst Orthoscience, Inc.20190—
+3K182500Catalyst CSR Press-Fit Humeral ComponentsCatalyst Orthoscience, Inc.20192—
+3K181287Catalyst CSR Shoulder SystemCatalyst Orthoscience, Inc.20183—
+3K173964OVOMotion Shoulder Arthroplasty SystemArthrosurface, Inc.20180—
+3K162800BLUEPRINT Patient Specific InstrumentationTornier S.A.S.201723—
+4K254084AETOS Shoulder System - CONCELOC GlenoidsSmith & Nephew, Inc.20260—
+4K252416AETOS Shoulder System Meta Humeral Prosthesis Size 0Smith & Nephew, Inc.20250—
+4K243955Precision AI Surgical Planning System (PAI-SPS)Precision AI Pty, Ltd.20251—
+4K240716AETOS Shoulder System Stemless Humeral ProsthesisSmith & Nephew, Inc.20243—
+4K230572AETOS Shoulder SystemSmith & Nephew, Inc.20231—
+4K222317Catalyst EA Convertible Stemmed ShoulderCatalyst Orthoscience, Inc.20221—
+4K203315BLUEPRINT™ Patient Specific InstrumentationTornier S.A.S.202118—
+4K191247SmartSPACE Shoulder SystemTechmah Medical, LLC20193—
+5K251558Precision AI Surgical Planning System (PAI-SPS)Precision AI Pty, Ltd.20260—
+5K252418Catalyst F1x Shoulder SystemCatalyst Orthoscience, Inc.20250—
+5K252129AETOS Shoulder System Stemless Humeral ProsthesisSmith & Nephew, Inc.20250—
+5K241292MyShoulder Planner (5.3SSWPL)Medacta International S.A.20250—
+5K232265BLUEPRINT™ Patient Specific InstrumentationTornier S.A.S.20243—
+5K222405Smart SPACE Shoulder Planner and 3D PositionersLima Corporate S.P.A.20220—
+5K213546ExactechGPS Total Shoulder Application, Equinoxe Planning SoftwareBlue Ortho202281
+5K211359Tornier Perform™ Patient-Matched Primary Reversed Glenoid and BLUEPRINT™ Patient…Tornier, Inc.202182
+5K202151Smart SPACE Shoulder SystemTechmah Medical, LLC20211—
+5K202454Smart SPACE Shoulder SystemTechmah Medical, LLC20201—
+6K252788Tornier Perform™ Reversed Monopost Glenoid (Perform Mono)Tornier, Inc.20260—
+6K252841Real Intelligence™ Cori™ XT (Cori XT)Blue Belt Technologies, Inc.20250—
+6K241491Blueprint Patient-Specific Instrumentation; Shoulder iD Primary Reversed GlenoidStryker Corporation (Tornier, S.A.S.)20241—
+6K241097Arthrex Virtual Implant Positioning (VIP) System SoftwareArthrex, Inc.20240—
+6K233199ROSA® Shoulder SystemOrthosoft Inc (D/B/A Zimmer Cas)20243—
+6K232425Signature™ ONE SystemOrthosoft Inc. (D/B/A) Zimmer Cas)20232—
+6K232521ExactechGPS® Total Ankle ApplicationBlue Ortho20230—
+6K230904Arthrex Virtual Implant Positioning (VIP) SystemArthrex, Inc.20231—
+7K260582ROSA® Shoulder SystemOrthosoft Inc. (d/b/a) Zimmer CAS20260—
+7K253674Blueprint Patient-Specific InstrumentationStryker Corporation (Tornier, S.A.S.)20260—
+7K260104Signature™ ONE SystemOrthosoft Inc. (d/b/a) Zimmer CAS20261—
+7K250108OptiVu™ ShoulderMr Surgical Solutions, LLC20251—
+8K261510Signature™ ONE SystemOrthosoft Inc. (d/b/a) Zimmer CAS20260—
+8K252170OptiVu™ ShoulderMr Surgical Solutions, LLC20250—