510(k) Report

Devices descending from K990137

365 later devices reach Anatomica Humeral Stem/Head Components through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K181287Catalyst CSR Shoulder SystemCatalyst Orthoscience, Inc.20183—
+6K173717Integra TITAN Reverse Shoulder SystemIntegra LifeSciences Corporation20183—
+6K173964OVOMotion Shoulder Arthroplasty SystemArthrosurface, Inc.20180—
+6K173073AltiVate Anatomic to Reverse Conversion ModuleEncore Medical L.P.20173—
+6K173372ExactechGPS Total Shoulder ApplicationBlue Ortho2017141
+6K172351AltiVate Reverse Humeral Stem, AltiVate Reverse Small Spacer, Altivate Reverse, Small…Encore Medical L.P.2017183
+6K172210ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…Stryker Trauma AG201710—
+6K162800BLUEPRINT Patient Specific InstrumentationTornier S.A.S.201723—
+6K152966Aequalis Fx2Tornier S.A.S.201601
+6K151293Aequalis Ascend Flex Shoulder System, Aequalis Reversed Shoulder ProsthesisTornier S.A.S.201520—
+6K140478Aequalis Reversed Shoulder ProsthesisTornier S.A.S.201421—
+6K141006RSP Humeral Socket InsertDjo Global2014212
+6K140904RSP Monoblock Stem with P2 Coating, Size 6Encore Medical L.P.201455—
+6K132285Aequalis Reversed Shoulder ProsthesisTornier S.A.S.201326—
+6K122698Aequalis Ascend Flex Shoulder SystemTornier S.A.S.2013962
+6K121493Ascend Shoulder SystemTornier, Inc.201297—
+7K262173N22 Offset Humeral HeadShoulder Innovations, Inc.20260—
+7K243826SMR Reverse HP Shoulder SystemLima Corporate S.P.A.20251—
+7K243955Precision AI Surgical Planning System (PAI-SPS)Precision AI Pty, Ltd.20251—
+7K241097Arthrex Virtual Implant Positioning (VIP) System SoftwareArthrex, Inc.20240—
+7K232425Signature™ ONE SystemOrthosoft Inc. (D/B/A) Zimmer Cas)20232—
+7K232583Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20231—
+7K222510Blueprint Mixed Reality systemTornier S.A.S.2023010
+7K222317Catalyst EA Convertible Stemmed ShoulderCatalyst Orthoscience, Inc.20221—
+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—
+7K190521Aequalis Ascend Flex Shoulder SystemTornier S.A.S.201912—
+7K181999Integra TITAN Reverse Shoulder SystemIntegra LifeSciences Corporation20182—
+7K181742ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…Stryker GmbH20189—
+7K171058Medacta Shoulder System: Threaded Glenoid BaseplateMedacta International S.A.20170—
+7K140082Aequalis (TM) Ascent (TM) Flex Shoulder SystemTornier S.A.S.201429—
+8K260104Signature™ ONE SystemOrthosoft Inc. (d/b/a) Zimmer CAS20261—
+8K252352SMR Shoulder System; PRIMA Glenoid System; PRIMA Humeral SystemLima Corporate S.P.A.20260—
+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—
+8K252418Catalyst F1x Shoulder SystemCatalyst Orthoscience, Inc.20250—
+8K250108OptiVu™ ShoulderMr Surgical Solutions, LLC20251—
+8K241292MyShoulder Planner (5.3SSWPL)Medacta International S.A.20250—
+8K232265BLUEPRINT™ Patient Specific InstrumentationTornier S.A.S.20243—
+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—
+8K211359Tornier Perform™ Patient-Matched Primary Reversed Glenoid and BLUEPRINT™ Patient…Tornier, Inc.202182
+8K202151Smart SPACE Shoulder SystemTechmah Medical, LLC20211—
+8K202454Smart SPACE Shoulder SystemTechmah Medical, LLC20201—
+8K201315PERFORM Humeral System – StemTornier, Inc.2020111
+8K182799Arthrex Univers II Shoulder Prosthesis System: Titanium Humeral HeadsArthrex, Inc.20190—
+8K183039ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…Stryker GmbH20198—
+8K181420Aequalis Flex Revive Shoulder SystemTornier, Inc.20184—
+9K261510Signature™ ONE SystemOrthosoft Inc. (d/b/a) Zimmer CAS20260—
+9K260582ROSA® Shoulder SystemOrthosoft Inc. (d/b/a) Zimmer CAS20260—
+9K252170OptiVu™ ShoulderMr Surgical Solutions, LLC20250—
+9K241878Tornier Humeral Reconstruction System (Tornier HRS); Tornier Perform Humeral System -…Stryker Corporation (Tornier, Inc.)20241—
+9K241491Blueprint Patient-Specific Instrumentation; Shoulder iD Primary Reversed GlenoidStryker Corporation (Tornier, S.A.S.)20241—
+9K241609Tornier Humeral Reconstruction System (Tornier HRS)Stryker Corporation (Tornier, Inc.)20240—
+9K220418Tornier Perform Humeral System – StemlessTornier, Inc.202201
+9K203375OVOMotion Reverse Shoulder Arthroplasty SystemArthrosurface, Inc.20210—
+9K202289ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…Stryker GmbH20202—
+9K191318AEQUALIS FLEX REVIVE Shoulder SystemTornier, Inc.201932
+10K253674Blueprint Patient-Specific InstrumentationStryker Corporation (Tornier, S.A.S.)20260—
+10K251686Tornier Humeral Reconstruction System Max (Tornier HRS Max)Tornier, Inc.202501