510(k) Report

Devices descending from K962101

283 later devices reach Zweymueller SL Femoral Hip Stem through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K083312Minihip StemCorin USA201015—
+4K083495Modification to: Metha Hip SystemAesculap Implant Systems, Inc.200959—
+4K081023Evolis Total Knee SystemMedacta International S.A.2008781
+4K082146Metha Short Stem Hip System XL Femoral HeadAesculap Implant Systems, Inc.20082—
+5K260182Avenir® Müller Stem; Avenir Complete™ Hip SystemZimmer, Inc.20260—
+5K252401implaFit® short stemsImplantcast GmbH20260—
+5K253171Libertas Taper Short (TS) Uncemented Femoral Stem (Libertas TS Stem)Maxx Orthopedics, Inc.20260—
+5K241241Z1 Cemented Hip SystemOrchard Medical Development, LLC20240—
+5K233476Z1 Hip SystemOrchard Medical Development202421
+5K232371Actinia® hip stemsImplantcast GmbH20231—
+5K223828BENCOX Delta Option HeadsCorentec Co., Ltd.20230—
+5K223223BENCOX Mirabo Z Cup CortiniumCorentec Co., Ltd.20230—
+5K210614BENCOX Mirabo Z Cup CortiniumCorentec Co., Ltd.20221—
+5K220468BENCOX Mirabo Cup SystemCorentec Co., Ltd.20221—
+5K210263Mpres Neck Preserving StemMedacta International S.A.20211—
+5K201657Corin Ltd. Hip Products: Trinity™ Acetabular System, Trinity™ PLUS Acetabular Shell…Corin, Ltd.20212—
+5K200823Zimmer, Inc. Hip Joint Prostheses MR Labeling IZimmer, Inc.202011
+5K200709Kyocera Bipolar Hip SystemKyocera Medical Technologies, Inc.20200—
+5K192189Avenir Complete Hip System, Size 0 Coxa VaraZimmer, Inc.20194—
+5K182221Bencox Mirabo Cup Multi HoleCorentec Co., Ltd.20193—
+5K182462Exactech Alteon Highly Polished Femoral StemExactech, Inc.20180—
+5K173455SurgTech Bipolar Head SystemSurgtech, Inc.20180—
+5K173794AMIStem-H Proximal Coating, AMIStem-P and AMIStem-P CollaredMedacta International S.A.20189—
+5K172806Bencox Mirabo Cup SystemCorentec Co., Ltd.20174—
+5K171249Entrada™ hip stemOrtho Development Corporation20172—
+5K162957U2 Femoral HeadUnited Orthopedic Corporation20171—
+5K162127Bencox M Stem Lateralized & Bencox Mirabo Cup SystemCorentec Co., Ltd.201661
+5K160266ICONACY (TM) I-Hip (TM)Iconacy Orthopedic Implants, LLC20160—
+5K151307ICONACY (TM) I-Hip (TM)Iconacy Orthopedic Implants, LLC20166—
+5K150855H-MAX S Femoral Hip SystemLima Corporate S.P.A.20152—
+5K150576TGM Biolox delta Ceramic HeadsTgm Medical, Inc.20150—
+5K150503Echo Bi-Metric Microplasty Line ExtensionBiomet, Inc.20150—
+5K143509MasterSL femoral stemLima Corporate S.P.A.20153—
+5K142069GMK ExtensionMedacta International20144—
+5K141821Alteon Neck Preserving Femoral Stem, Standard Offset, Size 6-7; Alteon Neck Preserving…Exactech, Inc.201401
+5K132572I-Hip Total Hip SystemIconacy Orthopedic Implants, LLC20147—
+5K133228Iconacy I-Hip System, Gradual Transitioning (GT) Femoral SystemIconacy Orthopedic Implants, LLC20147—
+5K131986Corin Minihip StemCorin USA20133—
+5K131310GMK Full PE Tibial ComponentsMedacta International20132—
+5K131279Iconacy I-Hip SystemIconacy Orthopedic Implants, LLC20138—
+5K122975GKS Prime Flex CR Total Knee SystemPermedica20120—
+5K121416GMK SphereMedacta International201220—
+5K120790GMK - Line ExtensionMedacta International201211—
+5K113571GMK Resufacing Patella Size 4Medacta International201223—
+5K113242Apex Arc Hip StemOmni Life Science, Inc.201252—
+5K113107Msa Hip SystemGlobal Manufacturing Technology20110—
+5K111193Apex Arc Hip StemOmni Life Science, Inc.201153—
+5K111283GMK Revision Hybrid LinersMedacta International20110—
+5K103518Trinity Acetabular SystemCorin USA20118—
+5K090988GMK Total Knee SystemMedacta International S.A.2009521
+5K091069Medacta Bone Screws - Evolis and VersafitMedacta International S.A.200923—
+6K262057GMK ExtensionMedacta International SA20260—
+6K260831Z1 Hip SystemZimmer, Inc.20260—
+6K251906Z1 Hip SystemZimmer, Inc.20251—
+6K251166Mfinity Femoral SystemMedacta International S.A.20250—
+6K250834Zimmer Biomet Ceramic Heads (22.2mm diameter)Zimmer Biomet20250—
+6K241472Icona Hip StemCorin U.S.A. Limited20241—
+6K234044ACS® LD FB Knee SystemImplantcast GmbH20241—
+6K233758Trivicta™ Hip StemOrtho Development Corp.20241—
+6K223548GMK Sphere & GMK SpheriKA CementlessMedacta International S.A.20231—
+6K221850GMK 3D Metal Tibial TrayMedacta International S.A.20221—
+6K211664GMK Sphere RevisionMedacta International S.A.20210—
+6K211866Bencox THR SystemCorentec Co., Ltd.20210—
+6K211004GMK Spherika Femurs and Fixed Tibial Trays PlusMedacta International S.A.20214—
+6K210062Mectaplug PE IIMedacta International S.A.20210—
+6K202684GMK Total Knee System - TiNbN CoatingMedacta International S.A.20203—
+6K202022GMK-SPHERE Tibial inserts FLEX Tibial Insert CR and Resurfacing Patella made of E-CROSS…Medacta International S.A.20201—
+6K192126AMIStem-P Short NeckMedacta International S.A.20191—
+6K190704Signature Ceramic Femoral HeadSignature Orthopaedics Pty, Ltd.20192—
+6K181171Zimmer Biomet Ceramic HeadsZimmer, Inc.201925
+6K181254Quadra PMedacta International S.A.20187—
+6K173890GMK Sphere - Kinematic AlignmentMedacta International S.A.20186—
+6K181635GMK Sphere CR Tibial InsertsMedacta International S.A.20182—
+6K162035GMK SphereMedacta International S.A.201710—
+6K160011H-Max S stemLima Corporate S.P.A.20161—
+6K140826GMK Sphere ExtensionMedacta International201417—
+6K133381Omni Arc Monoblock Hip StemOmnilife Science20142—
+6K133630GMK Short StemMedacta International20131—
+6K123991Depuy Corail Amt Hip ProsthesisDepuy France S.A.S.2013481
+6K123721GMK Revision ExtensionMedacta International20133—
+6K122185U-Motion II Acetabular SystemUnited Orthopedic Corp.20137—
+6K122232GMK NarrowMedacta International20128—
+6K103170GMK Revision Knee SC LinersMedacta International S.A.201128—
+6K103721Mpact Acetabular SystemMedacta International201121—
+6K103352Versafitcup CC TrioMedacta International20114—
+6K102437GMK Revision Knee SystemMedacta International S.A.201034—
+6K093806Myknee Cutting BlocksMedacta International S.A.201016—
+7K253630Mpact 3D Metal FoamMedacta International S.A.20260—
+7K261576Icona Hip StemCorin, Ltd.20260—
+7K253328GMK 3D Metal Tibial Tray ExtensionMedacta International S.A.20260—
+7K251043Mpact 3D Metal Implants Extension – DMLS TechnologyMedacta International S.A.20260—
+7K241461Mpact Constrained LinerMedacta International S.A.20251—
+7K251052Trivicta® Hip StemOrtho Development Corp.20250—
+7K243574Evolution® Total Knee Systems - Kinematic Alignment Instrumentation and TechniqueMicroport Orthopedics, Inc.20251—
+7K240452Ceramic Femoral HeadMicroport Orthopedics, Inc.20240—
+7K223745Novae® Dual Mobility System, Hype® Hip SystemSerf20231—
+7K231526CORAIL Cemented Femoral StemDepuy Ireland UC20230—
+7K230011Mpact ExtensionMedacta International S.A.20233—
+7K231037MyKnee UNI-STMedacta International S.A.20230—
+7K221149U-Motion II Acetabular System-Extension lineUnited Orthopedic Corporation20231—