510(k) Report

Devices descending from K072888

103 later devices reach Revelation and Linear Hip Stems and FMP Acetabular Shells (Spiked… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K190057DJO Acetabular SystemEncore Medical L.P.201925
+1K112069RSP Glenoid Baseplate Porous CoatedEncore Medical L.P.2011741
+1K100445Klassic HD Hip SystemTotal Joint Orthopedics, Inc.201025—
+2K251833EMPOWR Acetabular® Liner ExtensionEncore Medical L.P.20250—
+2K233481AltiVate Reverse® GlenoidEncore Medical L.P.202448
+2K220483Platform® Acetabular SystemTotal Joint Orthopedics, Inc.20220—
+2K213580Adapter Sleeve for BIOLOX® OPTION Femoral Head, +10.5mm head lengthTotal Joint Othopedics, Inc.20211—
+2K201905SMR 140° Reverse Humeral BodyLima Corporate S.P.A.20200—
+2K191708Origin Stem, Evolve Stem, Aria Hip Stem, Remedy Stem, CoCr Femoral HeadSignature Orthopaedics Pty, Ltd.20200—
+2K191399BIOLOX CONTOURA Ceramic Femoral HeadTotal Joint Othopedics, Inc.20190—
+2K183042SMR Lateralized Connectors with screwsLima Corporate S.P.A.20190—
+2K180929Klassic HD® Hip SystemTotal Joint Orthopedics, Inc.20185—
+2K171962Klassic HD® Hip SystemTotal Joint Othopedics, Inc.20170—
+2K161073Klassic HD Hip SystemTotal Joint Othopedics, Inc.20166—
+2K151293Aequalis Ascend Flex Shoulder System, Aequalis Reversed Shoulder ProsthesisTornier S.A.S.201520—
+2K151440Klassic HD Hip SystemTotal Joint Orthopedics, Inc.20151—
+2K143113Klassic BiPolar SystemTotal Joint Orthopedics201501
+2K143407Klassic HD Hip SystemTotal Joint Othopedics, Inc.201416—
+2K141972Klassic HD Acetabular Insert with E-Link PolyTotal Joint Orthopedics, Inc.201414—
+2K140904RSP Monoblock Stem with P2 Coating, Size 6Encore Medical L.P.201455—
+2K133832Klassic HD Hip System, Offset Femoral Stem, Non-Porous / PorousTotal Joint Orthopedics, Inc.20142—
+2K131454Klassic HD (TM) Extended Offset Femoral HeadTotal Joint Orthopedics, Inc.20142—
+2K130895Reunion Rsa Shoulder SystemHowmedica Osteonics Corp.201314—
+3K253592Zimmer Biomet Reverse Shoulder Prosthesis (Alliance Humeral Bearings, Identity Humeral…Zimmer, Inc.20260—
+3K252567AltiVate Reverse® ADLC GlenosphereEncore Medical L.P.20260—
+3K252141AltiVate Reverse® GlenoidEncore Medical L.P.20250—
+3K251184AltiVate Reverse Shoulder System; RSP Shoulder System; SMR Shoulder System; PRIMA…Encore Medical L.P.20250—
+3K243809Biolox® Delta Revision headsLimacorporate20250—
+3K232583Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20231—
+3K220847AETOS Shoulder SystemSmith & Nephew, Inc.20235—
+3K221675United U2 femoral head, 22mm delta ceramic headUnited Orthopedic Corporation20220—
+3K190521Aequalis Ascend Flex Shoulder SystemTornier S.A.S.201912—
+3K183077Delta Xtend Reverse Shoulder SystemDepuy (Ireland)20190—
+3K180263EcoFit Vit E Acetabular SystemImplantcast GmbH20185—
+3K173104Klassic HD® Hooded Acetabular Insert with E-Link® Poly, Klassic HD® Low Profile…Total Joint Orthopedics, Inc.20176—
+3K163577Ecofit® Hip SystemImplantcast GmbH201791
+3K161863ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty (RSA)…Stryker GmbH201613—
+3K162024AltiVate Anatomic Shoulder SystemEncore Medical L.P.2016346
+3K141990Encore Humeral Shoulder StemEncore Medical L.P.2014193
+4K252451EPORE® XO cup systemImplantcast GmbH20260—
+4K254084AETOS Shoulder System - CONCELOC GlenoidsSmith & Nephew, Inc.20260—
+4K260037implantcast Packaging System UpdateImplantcast GmbH20260—
+4K252416AETOS Shoulder System Meta Humeral Prosthesis Size 0Smith & Nephew, Inc.20250—
+4K240716AETOS Shoulder System Stemless Humeral ProsthesisSmith & Nephew, Inc.20243—
+4K240834EcoFit® short stem cementless cpTiImplantcast GmbH20241—
+4K234105Catalyst F1x Shoulder SystemCatalyst Orthoscience, Inc.20240—
+4K223103BethaLoc® stem cementless HAImplantcast GmbH20231—
+4K230572AETOS Shoulder SystemSmith & Nephew, Inc.20231—
+4K210678implaFit® hip stemsImplantcast GmbH20223—
+4K213387AltiVate® Anatomic Shoulder AG e+™ with MarkersEncore Medical L.P.20221—
+4K212800PRIMA Humeral System and SMR Glenosphere Ø42Lima Corporate S.P.A.202222
+4K202716Ignite Anatomic Shoulder SystemIgnite Orthopedics, LLC202113—
+4K202611Catalyst OrthoScience R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20215—
+4K203420EcoFit® Hip SystemImplantcast GmbH20214—
+4K203026AltiVate® Anatomic Pegged Glenoid with MarkersEncore Medical L.P.20202—
+4K202098GLOBAL UNITE™ Platform Shoulder SystemDepuy Ireland UC20201—
+4K201315PERFORM Humeral System – StemTornier, Inc.2020111
+4K193226AltiVate Anatomic Canal-Sparing (CS) ShoulderEncore Medical L.P.20204—
+4K190290AltiVate Reverse Humeral Stem, 48mmEncore Medical L.P.201915—
+4K172456Bone Screws 6.5mmLima Corporate S.P.A.201812
+4K173073AltiVate Anatomic to Reverse Conversion ModuleEncore Medical L.P.20173—
+4K172351AltiVate Reverse Humeral Stem, AltiVate Reverse Small Spacer, Altivate Reverse, Small…Encore Medical L.P.2017183
+4K172210ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…Stryker Trauma AG201710—
+5K260721Tornier Perform Advanced GlenoidTornier, Inc.20260—
+5K252401implaFit® short stemsImplantcast GmbH20260—
+5K252129AETOS Shoulder System Stemless Humeral ProsthesisSmith & Nephew, Inc.20250—
+5K241878Tornier Humeral Reconstruction System (Tornier HRS); Tornier Perform Humeral System -…Stryker Corporation (Tornier, Inc.)20241—
+5K240876Identity Shoulder SystemZimmer, Inc.20241—
+5K233712PRIMA Humeral System; PRIMA TT GlenoidLima Corporate S.P.A.20241—
+5K230831INHANCE Shoulder System Convertible Glenoid Inserts, INHANCE Convertible GlenoidDepuy Ireland UC20230—
+5K232371Actinia® hip stemsImplantcast GmbH20231—
+5K222592AltiVate® Anatomic Shoulder AG e+™ with MarkersEncore Medical L.P.20230—
+5K223655Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20230—
+5K223211INHANCETM Shoulder System – Humeral Stems and StemlessDepuy Ireland UC20220—
+5K222317Catalyst EA Convertible Stemmed ShoulderCatalyst Orthoscience, Inc.20221—
+5K220418Tornier Perform Humeral System – StemlessTornier, Inc.202201
+5K221467INHANCETM Reverse Glenoid Peripheral PostsDepuy Ireland UC20220—
+5K213349Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20222—
+5K212933INHANCETM Hybrid Anatomic Glenoid ImplantDepuy Ireland UC20221—
+5K212737INHANCE™ Reverse Shoulder SystemDepuy Ireland UC20229—
+5K202024ARROW Short Stem Humeral SystemFH Industrie20212—
+5K212710GLOBAL UNITE™ Platform Shoulder SystemDepuy Ireland UC20210—
+5K211991Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20213—
+5K203108Ignite Stemless Anatomic Shoulder SystemIgnite Orthopedics, LLC20213—
+5K181742ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…Stryker GmbH20189—
+6K254128InSet Reverse Total Shoulder SystemShoulder Innovations, Inc.20260—
+6K253624INHANCE™ Reverse Shoulder SystemDepuy Ireland UC20260—
+6K250644MSS - Monobloc stemMedacta International S.A.202611
+6K254003JARVIS Metaphyseal StemFH Industrie20260—
+6K252418Catalyst F1x Shoulder SystemCatalyst Orthoscience, Inc.20250—
+6K251686Tornier Humeral Reconstruction System Max (Tornier HRS Max)Tornier, Inc.202501
+6K253345JARVIS Diaphyseal Stem StandardFH Industrie20251—
+6K241817InSet Total Shoulder SystemShoulder Innovations, Inc.20251—
+6K243248Inhance Intact™Depuy Ireland UC20240—
+6K183039ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…Stryker GmbH20198—
+7K262173N22 Offset Humeral HeadShoulder Innovations, Inc.20260—
+7K261016MSS - Humeral reverse liners extensionMedacta International, SA20260—
+7K203375OVOMotion Reverse Shoulder Arthroplasty SystemArthrosurface, Inc.20210—
+7K202289ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…Stryker GmbH20202—
+7K191433AGILON® XO Shoulder Replacement SystemImplantcast GmbH20203—