510(k) Report

Devices descending from K021403

132 later devices reach HA Mallory/Head Porous Femoral Stem & HA Mallory/Head Porous Lateralized… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K160907DePuy Actis DuoFix Hip ProsthesisDepuy (Ireland)201626—
+8K261576Icona Hip StemCorin, Ltd.20260—
+8K260721Tornier Perform Advanced GlenoidTornier, Inc.20260—
+8K243192iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with Plasma Sprayed CPTi…Nextstep Arthopedix, LLC20260—
+8K252129AETOS Shoulder System Stemless Humeral ProsthesisSmith & Nephew, Inc.20250—
+8K251292RECLAIM Monobloc Revision Femoral StemDepuy Ireland UC20251—
+8K251184AltiVate Reverse Shoulder System; RSP Shoulder System; SMR Shoulder System; PRIMA…Encore Medical L.P.20250—
+8K243977EMPHASYS Acetabular SystemDepuy Ireland UC20251—
+8K241878Tornier Humeral Reconstruction System (Tornier HRS); Tornier Perform Humeral System -…Stryker Corporation (Tornier, Inc.)20241—
+8K242084EMPHASYS Acetabular Shell with RapiTite HADepuy Ireland UC20240—
+8K223876SMR Shoulder SystemLima Corporate S.P.A.20233—
+8K222427PRIMA TT GlenoidLima Corporate S.P.A.202223
+8K220418Tornier Perform Humeral System – StemlessTornier, Inc.202201
+8K210678implaFit® hip stemsImplantcast GmbH20223—
+8K220731Insignia Hip Stem, Restoration Modular 115mm Conical Distal StemStryker20226—
+8K221104Actera™ hip systemConformis, Inc.202211
+8K212800PRIMA Humeral System and SMR Glenosphere Ø42Lima Corporate S.P.A.202222
+9K260173M-Vizion Femoral Revision System ExtensionMedacta International S.A.20260—
+9K260037implantcast Packaging System UpdateImplantcast GmbH20260—
+9K252401implaFit® short stemsImplantcast GmbH20260—
+9K252067Velora Acetabular SystemRestor3D, Inc.20250—
+9K251686Tornier Humeral Reconstruction System Max (Tornier HRS Max)Tornier, Inc.202501
+9K243826SMR Reverse HP Shoulder SystemLima Corporate S.P.A.20251—
+9K233712PRIMA Humeral System; PRIMA TT GlenoidLima Corporate S.P.A.20241—
+9K233498Stryker Orthopaedics Hip Systems Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics20234—
+9K231099SMR Hybrid Glenoid SystemLima Corporate S.P.A.20230—
+9K232371Actinia® hip stemsImplantcast GmbH20231—
+9K231178ACTERA™ hip systemConformis, Inc.20230—
+10K261624Omnifit® 20° Series I Insert;Omnifit® Crossfire® 10° Series II Insert; Constrained…Howmedica Osteonics Corp., Dba Stryker Orthopaedics202602
+10K252352SMR Shoulder System; PRIMA Glenoid System; PRIMA Humeral SystemLima Corporate S.P.A.20260—
+10K243784Stryker Orthopaedics Hip Devices Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics20252—
+10K240418Stryker Orthopaedics Hip Systems Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics20240—