510(k) Report

Devices descending from K895226

236 later devices reach Neer II Total Shoulder System & Prosthesis through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K140082Aequalis (TM) Ascent (TM) Flex Shoulder SystemTornier S.A.S.201429—
+8K132285Aequalis Reversed Shoulder ProsthesisTornier S.A.S.201326—
+9K254084AETOS Shoulder System - CONCELOC GlenoidsSmith & Nephew, Inc.20260—
+9K240716AETOS Shoulder System Stemless Humeral ProsthesisSmith & Nephew, Inc.20243—
+9K222592AltiVate® Anatomic Shoulder AG e+™ with MarkersEncore Medical L.P.20230—
+9K223876SMR Shoulder SystemLima Corporate S.P.A.20233—
+9K222936Humeris® 135 Shoulder SystemFx Shoulder USA, Inc.20220—
+9K222427PRIMA TT GlenoidLima Corporate S.P.A.202223
+9K222482AGILON XO Shoulder SystemImplantcast GmbH20223—
+9K213117FX V135 Shoulder ProsthesisFx Shoulder USA, Inc.20224—
+9K201315PERFORM Humeral System – StemTornier, Inc.2020111
+9K191698TiN Coated Humeral HeadFx Shoulder USA, Inc.20200—
+9K191146Humelock TiN Coated GlenosphereFx Shoulder USA, Inc.202001
+9K193394Humeral Cup Stability & Humeral Cup 135/145o StabilityFx Shoulder USA, Inc.20203—
+9K192799Glenoid Baseplate with ScrewFx Shoulder USA, Inc.20202—
+9K19220632mm Glenosphere and Humeral CupFx Shoulder USA, Inc.201941
+9K182799Arthrex Univers II Shoulder Prosthesis System: Titanium Humeral HeadsArthrex, Inc.20190—
+9K183039ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…Stryker GmbH20198—
+9K181999Integra TITAN Reverse Shoulder SystemIntegra LifeSciences Corporation20182—
+9K181420Aequalis Flex Revive Shoulder SystemTornier, Inc.20184—
+9K171058Medacta Shoulder System: Threaded Glenoid BaseplateMedacta International S.A.20170—
+10K254154FX V135 EASYTECH® Shoulder SystemFX Shoulder Solutions, Inc.20260—
+10K252129AETOS Shoulder System Stemless Humeral ProsthesisSmith & Nephew, Inc.20250—
+10K243826SMR Reverse HP Shoulder SystemLima Corporate S.P.A.20251—
+10K241878Tornier Humeral Reconstruction System (Tornier HRS); Tornier Perform Humeral System -…Stryker Corporation (Tornier, Inc.)20241—
+10K241609Tornier Humeral Reconstruction System (Tornier HRS)Stryker Corporation (Tornier, Inc.)20240—
+10K231099SMR Hybrid Glenoid SystemLima Corporate S.P.A.20230—
+10K223801FX V135(TM) Shoulder ProsthesisFx Shoulder USA, Inc.20232—
+10K220418Tornier Perform Humeral System – StemlessTornier, Inc.202201
+10K210790Lateralized and Augmented BaseplatesFx Shoulder USA, Inc.20211—
+10K203375OVOMotion Reverse Shoulder Arthroplasty SystemArthrosurface, Inc.20210—
+10K202289ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…Stryker GmbH20202—
+10K191318AEQUALIS FLEX REVIVE Shoulder SystemTornier, Inc.201932
+11K252352SMR Shoulder System; PRIMA Glenoid System; PRIMA Humeral SystemLima Corporate S.P.A.20260—
+11K251686Tornier Humeral Reconstruction System Max (Tornier HRS Max)Tornier, Inc.202501
+11K240278Full Wedge Lateralized and Augmented BaseplatesFx Shoulder USA, Inc.20240—