510(k) Report

Devices descending from K043123

131 later devices reach Apex Modular HA Hip Stem through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K261576Icona Hip StemCorin, Ltd.20260—
+7K260721Tornier Perform Advanced GlenoidTornier, Inc.20260—
+7K243192iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with Plasma Sprayed CPTi…Nextstep Arthopedix, LLC20260—
+7K252129AETOS Shoulder System Stemless Humeral ProsthesisSmith & Nephew, Inc.20250—
+7K251292RECLAIM Monobloc Revision Femoral StemDepuy Ireland UC20251—
+7K251184AltiVate Reverse Shoulder System; RSP Shoulder System; SMR Shoulder System; PRIMA…Encore Medical L.P.20250—
+7K243977EMPHASYS Acetabular SystemDepuy Ireland UC20251—
+7K241878Tornier Humeral Reconstruction System (Tornier HRS); Tornier Perform Humeral System -…Stryker Corporation (Tornier, Inc.)20241—
+7K242084EMPHASYS Acetabular Shell with RapiTite HADepuy Ireland UC20240—
+7K223876SMR Shoulder SystemLima Corporate S.P.A.20233—
+7K222427PRIMA TT GlenoidLima Corporate S.P.A.202223
+7K220418Tornier Perform Humeral System – StemlessTornier, Inc.202201
+7K210678implaFit® hip stemsImplantcast GmbH20223—
+7K220731Insignia Hip Stem, Restoration Modular 115mm Conical Distal StemStryker20226—
+7K221104Actera™ hip systemConformis, Inc.202211
+7K212800PRIMA Humeral System and SMR Glenosphere Ø42Lima Corporate S.P.A.202222
+8K260173M-Vizion Femoral Revision System ExtensionMedacta International S.A.20260—
+8K260037implantcast Packaging System UpdateImplantcast GmbH20260—
+8K252401implaFit® short stemsImplantcast GmbH20260—
+8K252067Velora Acetabular SystemRestor3D, Inc.20250—
+8K251686Tornier Humeral Reconstruction System Max (Tornier HRS Max)Tornier, Inc.202501
+8K243826SMR Reverse HP Shoulder SystemLima Corporate S.P.A.20251—
+8K233712PRIMA Humeral System; PRIMA TT GlenoidLima Corporate S.P.A.20241—
+8K233498Stryker Orthopaedics Hip Systems Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics20234—
+8K231099SMR Hybrid Glenoid SystemLima Corporate S.P.A.20230—
+8K232371Actinia® hip stemsImplantcast GmbH20231—
+8K231178ACTERA™ hip systemConformis, Inc.20230—
+9K261624Omnifit® 20° Series I Insert;Omnifit® Crossfire® 10° Series II Insert; Constrained…Howmedica Osteonics Corp., Dba Stryker Orthopaedics202602
+9K252352SMR Shoulder System; PRIMA Glenoid System; PRIMA Humeral SystemLima Corporate S.P.A.20260—
+9K243784Stryker Orthopaedics Hip Devices Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics20252—
+9K240418Stryker Orthopaedics Hip Systems Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics20240—