510(k) Report

Devices descending from K000788

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K250375Allure Hip Stem and Intramedullary PlugsWaldemar Link GmbH & Co. KG20250—
+6K252411JARVIS Glenoid Reverse Shoulder ProsthesisFH Industrie20250—
+6K250989Stryker and Serf hip devicesHowmedica Osteonics Corp (Dba Stryker Orthopaedics)20250—
+6K251166Mfinity Femoral SystemMedacta International S.A.20250—
+6K251052Trivicta® Hip StemOrtho Development Corp.20250—
+6K250444NEXUS® Hip StemMicroport Orthopedics, Inc.20250—
+6K243029Origin™ TT StemSignature Orthopaedics Pty, Ltd.20250—
+6K241817InSet Total Shoulder SystemShoulder Innovations, Inc.20251—
+6K241875TheRay Collared and Collarless Femoral StemNextstep Arthropedix202411
+6K241043Augment Off-Axis Instrument SystemFix Surgical202415
+6K233758Trivicta™ Hip StemOrtho Development Corp.20241—
+6K231873DePuy SUMMIT Porocoat Hip Prosthesis – MR Conditional, DePuy SUMMIT DuoFix Hip…Depuy Ireland UC20245—
+6K230831INHANCE Shoulder System Convertible Glenoid Inserts, INHANCE Convertible GlenoidDepuy Ireland UC20230—
+6K233233EMPHASYS Femoral StemsDepuy Ireland UC20230—
+6K232583Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20231—
+6K230572AETOS Shoulder SystemSmith & Nephew, Inc.20231—
+6K220847AETOS Shoulder SystemSmith & Nephew, Inc.20235—
+6K223211INHANCETM Shoulder System – Humeral Stems and StemlessDepuy Ireland UC20220—
+6K213770SP-CL Hip Stem and LCU Hip SystemWaldemar Link GmbH & Co. KG20220—
+6K221467INHANCETM Reverse Glenoid Peripheral PostsDepuy Ireland UC20220—
+6K213839DePuy Corail AMT Hip ProsthesisDePuy Orthopaedics, Inc.20220—
+6K212992LINK® Embrace Shoulder System - Reverse ConfigurationWaldemar Link GmbH & Co. KG20210—
+6K211703Insignia Hip StemStryker Orthopaedics20217—
+6K210717Bone Screws dia. 5,0 mmLima Corporate S.P.A.20218—
+6K210899LINK Embrace Shoulder System- Anatomical ConfigurationWaldemar Link GmbH & Co. KG20210—
+6K210581Actis DuoFix Hip Prosthesis- CollarlessDepuy Ireland UC202113—
+6K202472ACTIS Duofix Hip ProsthesisDePuy Orthopaedics, Inc.202015—
+6K193398Summit DuoFix HA CoatingDePuy Orthopaedics, Inc.202020—
+6K190521Aequalis Ascend Flex Shoulder SystemTornier S.A.S.201912—
+6K160907DePuy Actis DuoFix Hip ProsthesisDepuy (Ireland)201626—
+7K262173N22 Offset Humeral HeadShoulder Innovations, Inc.20260—
+7K261683Augment Off-Axis Instrument SystemZimmer, Inc.20260—
+7K261016MSS - Humeral reverse liners extensionMedacta International, SA20260—
+7K243192iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with Plasma Sprayed CPTi…Nextstep Arthopedix, LLC20260—
+7K254084AETOS Shoulder System - CONCELOC GlenoidsSmith & Nephew, Inc.20260—
+7K252416AETOS Shoulder System Meta Humeral Prosthesis Size 0Smith & Nephew, Inc.20250—
+7K251292RECLAIM Monobloc Revision Femoral StemDepuy Ireland UC20251—
+7K243977EMPHASYS Acetabular SystemDepuy Ireland UC20251—
+7K240716AETOS Shoulder System Stemless Humeral ProsthesisSmith & Nephew, Inc.20243—
+7K242084EMPHASYS Acetabular Shell with RapiTite HADepuy Ireland UC20240—
+7K234105Catalyst F1x Shoulder SystemCatalyst Orthoscience, Inc.20240—
+7K210678implaFit® hip stemsImplantcast GmbH20223—
+7K220731Insignia Hip Stem, Restoration Modular 115mm Conical Distal StemStryker20226—
+7K221104Actera™ hip systemConformis, Inc.202211
+7K220792SMR Reverse LinerLima Corporate S.P.A.20227—
+7K201315PERFORM Humeral System – StemTornier, Inc.2020111
+8K260721Tornier Perform Advanced GlenoidTornier, Inc.20260—
+8K260037implantcast Packaging System UpdateImplantcast GmbH20260—
+8K252401implaFit® short stemsImplantcast GmbH20260—
+8K252067Velora Acetabular SystemRestor3D, Inc.20250—
+8K252129AETOS Shoulder System Stemless Humeral ProsthesisSmith & Nephew, Inc.20250—
+8K251184AltiVate Reverse Shoulder System; RSP Shoulder System; SMR Shoulder System; PRIMA…Encore Medical L.P.20250—
+8K241878Tornier Humeral Reconstruction System (Tornier HRS); Tornier Perform Humeral System -…Stryker Corporation (Tornier, Inc.)20241—
+8K233498Stryker Orthopaedics Hip Systems Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics20234—
+8K232371Actinia® hip stemsImplantcast GmbH20231—
+8K231178ACTERA™ hip systemConformis, Inc.20230—
+8K223876SMR Shoulder SystemLima Corporate S.P.A.20233—
+8K222427PRIMA TT GlenoidLima Corporate S.P.A.202223
+8K220418Tornier Perform Humeral System – StemlessTornier, Inc.202201
+8K212800PRIMA Humeral System and SMR Glenosphere Ø42Lima Corporate S.P.A.202222
+9K261624Omnifit® 20° Series I Insert;Omnifit® Crossfire® 10° Series II Insert; Constrained…Howmedica Osteonics Corp., Dba Stryker Orthopaedics202602
+9K251686Tornier Humeral Reconstruction System Max (Tornier HRS Max)Tornier, Inc.202501
+9K243826SMR Reverse HP Shoulder SystemLima Corporate S.P.A.20251—
+9K243784Stryker Orthopaedics Hip Devices Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics20252—
+9K240418Stryker Orthopaedics Hip Systems Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics20240—
+9K233712PRIMA Humeral System; PRIMA TT GlenoidLima Corporate S.P.A.20241—
+9K231099SMR Hybrid Glenoid SystemLima Corporate S.P.A.20230—
+10K252352SMR Shoulder System; PRIMA Glenoid System; PRIMA Humeral SystemLima Corporate S.P.A.20260—