510(k) Report

Devices descending from K051075

248 later devices reach Encore Reverse Shoulder Prosthesis through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K191146Humelock TiN Coated GlenosphereFx Shoulder USA, Inc.202001
+5K193394Humeral Cup Stability & Humeral Cup 135/145o StabilityFx Shoulder USA, Inc.20203—
+5K192799Glenoid Baseplate with ScrewFx Shoulder USA, Inc.20202—
+5K190588Integra TITAN Reverse Shoulder SystemIntegra LifeSciences Corporation20194—
+5K190911Physica KR Liner and SMR Reverse Humeral LinerLimacorporate20198—
+5K191247SmartSPACE Shoulder SystemTechmah Medical, LLC20193—
+5K19220632mm Glenosphere and Humeral CupFx Shoulder USA, Inc.201941
+5K182799Arthrex Univers II Shoulder Prosthesis System: Titanium Humeral HeadsArthrex, Inc.20190—
+5K181742ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…Stryker GmbH20189—
+5K181420Aequalis Flex Revive Shoulder SystemTornier, Inc.20184—
+5K173717Integra TITAN Reverse Shoulder SystemIntegra LifeSciences Corporation20183—
+6K254154FX V135 EASYTECH® Shoulder SystemFX Shoulder Solutions, Inc.20260—
+6K251558Precision AI Surgical Planning System (PAI-SPS)Precision AI Pty, Ltd.20260—
+6K241292MyShoulder Planner (5.3SSWPL)Medacta International S.A.20250—
+6K241609Tornier Humeral Reconstruction System (Tornier HRS)Stryker Corporation (Tornier, Inc.)20240—
+6K232265BLUEPRINT™ Patient Specific InstrumentationTornier S.A.S.20243—
+6K223801FX V135(TM) Shoulder ProsthesisFx Shoulder USA, Inc.20232—
+6K223876SMR Shoulder SystemLima Corporate S.P.A.20233—
+6K222405Smart SPACE Shoulder Planner and 3D PositionersLima Corporate S.P.A.20220—
+6K222427PRIMA TT GlenoidLima Corporate S.P.A.202223
+6K213546ExactechGPS Total Shoulder Application, Equinoxe Planning SoftwareBlue Ortho202281
+6K211359Tornier Perform™ Patient-Matched Primary Reversed Glenoid and BLUEPRINT™ Patient…Tornier, Inc.202182
+6K210790Lateralized and Augmented BaseplatesFx Shoulder USA, Inc.20211—
+6K202151Smart SPACE Shoulder SystemTechmah Medical, LLC20211—
+6K202454Smart SPACE Shoulder SystemTechmah Medical, LLC20201—
+6K191318AEQUALIS FLEX REVIVE Shoulder SystemTornier, Inc.201932
+6K183039ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…Stryker GmbH20198—
+6K181999Integra TITAN Reverse Shoulder SystemIntegra LifeSciences Corporation20182—
+7K252788Tornier Perform™ Reversed Monopost Glenoid (Perform Mono)Tornier, Inc.20260—
+7K252841Real Intelligence™ Cori™ XT (Cori XT)Blue Belt Technologies, Inc.20250—
+7K243826SMR Reverse HP Shoulder SystemLima Corporate S.P.A.20251—
+7K241491Blueprint Patient-Specific Instrumentation; Shoulder iD Primary Reversed GlenoidStryker Corporation (Tornier, S.A.S.)20241—
+7K241097Arthrex Virtual Implant Positioning (VIP) System SoftwareArthrex, Inc.20240—
+7K240278Full Wedge Lateralized and Augmented BaseplatesFx Shoulder USA, Inc.20240—
+7K233199ROSA® Shoulder SystemOrthosoft Inc (D/B/A Zimmer Cas)20243—
+7K231099SMR Hybrid Glenoid SystemLima Corporate S.P.A.20230—
+7K232425Signature™ ONE SystemOrthosoft Inc. (D/B/A) Zimmer Cas)20232—
+7K232521ExactechGPS® Total Ankle ApplicationBlue Ortho20230—
+7K230904Arthrex Virtual Implant Positioning (VIP) SystemArthrex, Inc.20231—
+7K203375OVOMotion Reverse Shoulder Arthroplasty SystemArthrosurface, Inc.20210—
+7K202289ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…Stryker GmbH20202—
+8K260582ROSA® Shoulder SystemOrthosoft Inc. (d/b/a) Zimmer CAS20260—
+8K253674Blueprint Patient-Specific InstrumentationStryker Corporation (Tornier, S.A.S.)20260—
+8K260104Signature™ ONE SystemOrthosoft Inc. (d/b/a) Zimmer CAS20261—
+8K252352SMR Shoulder System; PRIMA Glenoid System; PRIMA Humeral SystemLima Corporate S.P.A.20260—
+8K250108OptiVu™ ShoulderMr Surgical Solutions, LLC20251—
+9K261510Signature™ ONE SystemOrthosoft Inc. (d/b/a) Zimmer CAS20260—
+9K252170OptiVu™ ShoulderMr Surgical Solutions, LLC20250—