510(k) Report

Devices descending from K030373

278 later devices reach Alloclassic Zweymueller SL/SLL Femoral Stem through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K241241Z1 Cemented Hip SystemOrchard Medical Development, LLC20240—
+4K233476Z1 Hip SystemOrchard Medical Development202421
+4K232371Actinia® hip stemsImplantcast GmbH20231—
+4K223828BENCOX Delta Option HeadsCorentec Co., Ltd.20230—
+4K223223BENCOX Mirabo Z Cup CortiniumCorentec Co., Ltd.20230—
+4K210614BENCOX Mirabo Z Cup CortiniumCorentec Co., Ltd.20221—
+4K220468BENCOX Mirabo Cup SystemCorentec Co., Ltd.20221—
+4K210263Mpres Neck Preserving StemMedacta International S.A.20211—
+4K201657Corin Ltd. Hip Products: Trinity™ Acetabular System, Trinity™ PLUS Acetabular Shell…Corin, Ltd.20212—
+4K200823Zimmer, Inc. Hip Joint Prostheses MR Labeling IZimmer, Inc.202011
+4K200709Kyocera Bipolar Hip SystemKyocera Medical Technologies, Inc.20200—
+4K192189Avenir Complete Hip System, Size 0 Coxa VaraZimmer, Inc.20194—
+4K182221Bencox Mirabo Cup Multi HoleCorentec Co., Ltd.20193—
+4K182462Exactech Alteon Highly Polished Femoral StemExactech, Inc.20180—
+4K173455SurgTech Bipolar Head SystemSurgtech, Inc.20180—
+4K173794AMIStem-H Proximal Coating, AMIStem-P and AMIStem-P CollaredMedacta International S.A.20189—
+4K172806Bencox Mirabo Cup SystemCorentec Co., Ltd.20174—
+4K171249Entrada™ hip stemOrtho Development Corporation20172—
+4K162957U2 Femoral HeadUnited Orthopedic Corporation20171—
+4K162127Bencox M Stem Lateralized & Bencox Mirabo Cup SystemCorentec Co., Ltd.201661
+4K160266ICONACY (TM) I-Hip (TM)Iconacy Orthopedic Implants, LLC20160—
+4K151307ICONACY (TM) I-Hip (TM)Iconacy Orthopedic Implants, LLC20166—
+4K150855H-MAX S Femoral Hip SystemLima Corporate S.P.A.20152—
+4K150576TGM Biolox delta Ceramic HeadsTgm Medical, Inc.20150—
+4K150503Echo Bi-Metric Microplasty Line ExtensionBiomet, Inc.20150—
+4K143184Evolve UniPolar HeadSignature Orthopaedics Pty, Ltd.20151—
+4K143509MasterSL femoral stemLima Corporate S.P.A.20153—
+4K142069GMK ExtensionMedacta International20144—
+4K141821Alteon Neck Preserving Femoral Stem, Standard Offset, Size 6-7; Alteon Neck Preserving…Exactech, Inc.201401
+4K132572I-Hip Total Hip SystemIconacy Orthopedic Implants, LLC20147—
+4K133228Iconacy I-Hip System, Gradual Transitioning (GT) Femoral SystemIconacy Orthopedic Implants, LLC20147—
+4K131986Corin Minihip StemCorin USA20133—
+4K131310GMK Full PE Tibial ComponentsMedacta International20132—
+4K131279Iconacy I-Hip SystemIconacy Orthopedic Implants, LLC20138—
+4K122975GKS Prime Flex CR Total Knee SystemPermedica20120—
+4K121416GMK SphereMedacta International201220—
+4K120790GMK - Line ExtensionMedacta International201211—
+4K113571GMK Resufacing Patella Size 4Medacta International201223—
+4K113242Apex Arc Hip StemOmni Life Science, Inc.201252—
+4K113107Msa Hip SystemGlobal Manufacturing Technology20110—
+4K111193Apex Arc Hip StemOmni Life Science, Inc.201153—
+4K111283GMK Revision Hybrid LinersMedacta International20110—
+4K103518Trinity Acetabular SystemCorin USA20118—
+4K090988GMK Total Knee SystemMedacta International S.A.2009521
+4K091069Medacta Bone Screws - Evolis and VersafitMedacta International S.A.200923—
+5K262057GMK ExtensionMedacta International SA20260—
+5K260831Z1 Hip SystemZimmer, Inc.20260—
+5K251906Z1 Hip SystemZimmer, Inc.20251—
+5K251166Mfinity Femoral SystemMedacta International S.A.20250—
+5K250834Zimmer Biomet Ceramic Heads (22.2mm diameter)Zimmer Biomet20250—
+5K241472Icona Hip StemCorin U.S.A. Limited20241—
+5K234044ACS® LD FB Knee SystemImplantcast GmbH20241—
+5K233758Trivicta™ Hip StemOrtho Development Corp.20241—
+5K223548GMK Sphere & GMK SpheriKA CementlessMedacta International S.A.20231—
+5K221850GMK 3D Metal Tibial TrayMedacta International S.A.20221—
+5K211664GMK Sphere RevisionMedacta International S.A.20210—
+5K211866Bencox THR SystemCorentec Co., Ltd.20210—
+5K211004GMK Spherika Femurs and Fixed Tibial Trays PlusMedacta International S.A.20214—
+5K201047Fusion Taper SystemSignature Orthopaedics Pty, Ltd.20210—
+5K210062Mectaplug PE IIMedacta International S.A.20210—
+5K202684GMK Total Knee System - TiNbN CoatingMedacta International S.A.20203—
+5K202022GMK-SPHERE Tibial inserts FLEX Tibial Insert CR and Resurfacing Patella made of E-CROSS…Medacta International S.A.20201—
+5K192126AMIStem-P Short NeckMedacta International S.A.20191—
+5K190704Signature Ceramic Femoral HeadSignature Orthopaedics Pty, Ltd.20192—
+5K181171Zimmer Biomet Ceramic HeadsZimmer, Inc.201925
+5K181254Quadra PMedacta International S.A.20187—
+5K173890GMK Sphere - Kinematic AlignmentMedacta International S.A.20186—
+5K181635GMK Sphere CR Tibial InsertsMedacta International S.A.20182—
+5K162035GMK SphereMedacta International S.A.201710—
+5K160011H-Max S stemLima Corporate S.P.A.20161—
+5K140826GMK Sphere ExtensionMedacta International201417—
+5K133381Omni Arc Monoblock Hip StemOmnilife Science20142—
+5K133630GMK Short StemMedacta International20131—
+5K123991Depuy Corail Amt Hip ProsthesisDepuy France S.A.S.2013481
+5K123721GMK Revision ExtensionMedacta International20133—
+5K122185U-Motion II Acetabular SystemUnited Orthopedic Corp.20137—
+5K122232GMK NarrowMedacta International20128—
+5K103170GMK Revision Knee SC LinersMedacta International S.A.201128—
+5K103721Mpact Acetabular SystemMedacta International201121—
+5K103352Versafitcup CC TrioMedacta International20114—
+5K102437GMK Revision Knee SystemMedacta International S.A.201034—
+5K093806Myknee Cutting BlocksMedacta International S.A.201016—
+6K253630Mpact 3D Metal FoamMedacta International S.A.20260—
+6K261576Icona Hip StemCorin, Ltd.20260—
+6K253328GMK 3D Metal Tibial Tray ExtensionMedacta International S.A.20260—
+6K251043Mpact 3D Metal Implants Extension – DMLS TechnologyMedacta International S.A.20260—
+6K241461Mpact Constrained LinerMedacta International S.A.20251—
+6K251052Trivicta® Hip StemOrtho Development Corp.20250—
+6K243574Evolution® Total Knee Systems - Kinematic Alignment Instrumentation and TechniqueMicroport Orthopedics, Inc.20251—
+6K240452Ceramic Femoral HeadMicroport Orthopedics, Inc.20240—
+6K223745Novae® Dual Mobility System, Hype® Hip SystemSerf20231—
+6K231526CORAIL Cemented Femoral StemDepuy Ireland UC20230—
+6K230011Mpact ExtensionMedacta International S.A.20233—
+6K231037MyKnee UNI-STMedacta International S.A.20230—
+6K221149U-Motion II Acetabular System-Extension lineUnited Orthopedic Corporation20231—
+6K202568Mpact® 3D Metal Implants - DMLS TechnologyMedacta International S.A.20211—
+6K211657EMPHASYS Femoral StemsDepuy Ireland UC20217—
+6K200391MPACT ExtensionMedacta International S.A.20210—
+6K210010GMK Revision & Hinge Extension - TiNbN CoatingMedacta International S.A.20211—
+6K203755Shoulder System - TiNbN CoatingMedacta International S.A.20210—