510(k) Report

Devices descending from P960054

215 later devices reach S-Rom Poly-Dial Constrained Liner through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K122139Smith & Nephew R3 Constrained LinersSmith & Nephew, Inc.20121—
+1K030923Epsilon Durasul Constrained Acetabular LinerCenterpulse Orthopedics, Inc.200331—
+1K023794Constrained LinerEncore Medical L.P.200315—
+1K021826Trilogy Acetabular System Constrained Liner, Model 6154 SeriesZimmer, Inc.200216—
+1K021661Ringloc Constrained LinersBiomet Orthopedics, Inc.200232—
+1K021728Ringloc Constrained Liners IIBiomet, Inc.2002184—
+2K191708Origin Stem, Evolve Stem, Aria Hip Stem, Remedy Stem, CoCr Femoral HeadSignature Orthopaedics Pty, Ltd.20200—
+2K200823Zimmer, Inc. Hip Joint Prostheses MR Labeling IZimmer, Inc.202011
+2K162641Smith & Nephew, Inc. R3™ Constrained LinerSmith & Nephew, Inc.20170—
+2K112158Modulus Stems, Modulus Necks, Modular Femoral Heads, Cemented Cups, Lock Bipolar HeadsLima Corporate S.P.A.201213—
+2K092265Vesafitcup Double Mobility- Highcross Hxuhmwpe LinersMedacta International S.A.201023—
+2K071718Trilogy Longevity Constrained LinerZimmer, Inc.2007281
+2K040601Exactech Acumatch a-Series & MCS Constrained Acetabular LinersExactech, Inc.200411
+2K030047Freedom Constrained LinersBiomet, Inc.2003181—
+3K241461Mpact Constrained LinerMedacta International S.A.20251—
+3K250834Zimmer Biomet Ceramic Heads (22.2mm diameter)Zimmer Biomet20250—
+3K241767Versacem Acetabular Shell and Double Mobility HC LinersMedacta International S.A.20250—
+3K243809Biolox® Delta Revision headsLimacorporate20250—
+3K191374Revival Modular Hip StemCorin U.S.A. Limited20193—
+3K152903REVIVAL (TM) Modular Revision Hip StemCorin USA20164—
+3K150855H-MAX S Femoral Hip SystemLima Corporate S.P.A.20152—
+3K143453Mpact Double Mobility SystemMedacta International20151—
+3K142882G7 Freedom and Offset Liners, Freedom Head, Size 32Biomet, Inc.201517—
+3K141327Minima S SystemLima Corporate S.P.A.20145—
+3K140975Mastersl Femoral StemLima Corporate S.P.A.20144—
+3K131458Mpact DM Liner ConverterMedacta International20133—
+3K121874G7 Acetabular SystemBiomet Manufacturing Corp2012533
+3K120531Versafitcup CC Trio-Additional LinersMedacta International20122—
+3K103721Mpact Acetabular SystemMedacta International201121—
+3K103352Versafitcup CC TrioMedacta International20114—
+3K101730Longevity IT Highly Crosslinked Polyethylene Constrained LinersZimmer, Inc.20102—
+3K093561Zimmer Trabecular Metal Modular Acetabular SystemZimmer, Inc.20100—
+3K071676Exactech Novation Crown Cup Constrained Liners and RingsExactech, Inc.200702
+3K061654Trident Constrained Acetabular InsertHowmedica Osteonics Corp.200620—
+3K043537Taperloc 12/14 Taper Femoral ComponentsBiomet, Inc.2005160—
+4K260173M-Vizion Femoral Revision System ExtensionMedacta International S.A.20260—
+4K253948Momentum Acetabular Cup SystemUnited Orthopedic Corporation20260—
+4K253630Mpact 3D Metal FoamMedacta International S.A.20260—
+4K261624Omnifit® 20° Series I Insert;Omnifit® Crossfire® 10° Series II Insert; Constrained…Howmedica Osteonics Corp., Dba Stryker Orthopaedics202602
+4K252824Evolve AP Cup, World Finned Cup, World G-Zero Liner and Oddball Femoral HeadSignature Orthopaedics Pty, Ltd.20260—
+4K251043Mpact 3D Metal Implants Extension – DMLS TechnologyMedacta International S.A.20260—
+4K250450Coated hip implantsMedacta International S.A.20250—
+4K230011Mpact ExtensionMedacta International S.A.20233—
+4K231925MINIMA S SystemLima Corporate S.P.A.20230—
+4K211891DM Converter - TiN coatedMedacta International S.A.20220—
+4K212512G7® Vivacit-E® Freedom® Constrained LinerZimmer, Inc.20220—
+4K202568Mpact® 3D Metal Implants - DMLS TechnologyMedacta International S.A.20211—
+4K201657Corin Ltd. Hip Products: Trinity™ Acetabular System, Trinity™ PLUS Acetabular Shell…Corin, Ltd.20212—
+4K200391MPACT ExtensionMedacta International S.A.20210—
+4K190660G7 Acetabular System Longevity Highly Crosslinked Polyethylene, G7 Acetabular System…Zimmer, Inc.20194—
+4K183457Zimmer Biomet 12/14 CoCr Femoral Head and Freedom HeadZimmer, Inc.20190—
+4K183684Libertas – Taper Uncemented Femoral StemMaxx Orthopedics, Inc.20191—
+4K183532Latitud Hip Replacement SystemMeril Healthcare Pvt., Ltd.20190—
+4K190057DJO Acetabular SystemEncore Medical L.P.201925
+4K182321MobileLink Acetabular Cup SystemWaldemar Link GmbH & Co. KG20198—
+4K182221Bencox Mirabo Cup Multi HoleCorentec Co., Ltd.20193—
+4K183582MPACT ExtensionMedacta International S.A.20194—
+4K173380b-ONE® Total Hip SystemB-One Ortho, Corp.20180—
+4K171966Mpact® 3D Metal™ Implants and Augments 3D Metal™Medacta International S.A.20183—
+4K170473C2 femoral stemLima Corporate S.P.A.20170—
+4K160895Initia Total Hip System & BIOCERAM AZUL (R) HEADKyocera Medical Corporation20162—
+4K160011H-Max S stemLima Corporate S.P.A.20161—
+4K153345Stryker Orthopaedics Hip Systems Labeling UpdateStryker Orthopaedics2016171
+4K150007Modified Bencox Hip SystemCorentec Co., Ltd.20157—
+4K143509MasterSL femoral stemLima Corporate S.P.A.20153—
+4K142746G7 Finned Acetabular ShellBiomet Manufactuting Corp.20140—
+4K140669G7 Osseoti Acetublar ShellsBiomet, Inc.201435—
+4K132879Mpact ExtensionMedacta International201411—
+4K122783Plasmafit Acetabular Cup and Vitelene InsertAesculap Implant System, Inc.20130—
+4K131022Ovation 10/12 Hip StemOrtho Development Corp.20135—
+4K123619Intrablock Bioball Hip System (Ibs)Merete Medical GmbH20131—
+4K121297Origin Hip Stem, Femoral Head, Logical PX-Series Acetabular Shell, Locigal G-Series…Signature Orthopaedics Pty, Ltd.2012202
+4K122911Versafitcup CC Trio ExtensionMedacta International20121—
+4K122641Mpact ExtensionMedacta International201214—
+4K121034Ioi Total HipIconacy Orthopedic Implants, LLC201211—
+4K112897Renovis Surgical Hip Joint Replacement ProsthesisRenovis Surgical Technologies, LLC20128—
+4K112019Bencox ID Stem, Bencox Metal Head, Bencox Bipolar CupCorentec Co., Ltd.201110—
+4K111145Endo HeadMedacta International20110—
+4K110245United Utf StemUnited Orthopedic Corporation201171
+4K102399Consensus Taperset Hip SystemConsensus Orthopedics, Inc.201033—
+4K082446Biomet Metal-on-Metal Hip Systems- Expanded ContraindicationsBiomet, Inc.200821
+4K072101Rigi-Fix Hip Stem SystemImplants Intl., Ltd.20070—
+4K062775European Style Taper,Press-Fit Hip StemOrtho Development Corp.2007134
+4K061423M2A Magnum 12/14 Taper Inserts and One-Piece Modular HeadsBiomet Manufacturing Corp20063—
+5K261453G7® Acetabular SystemZimmer Biomet20260—
+5K261009MobileLink Acetabular Cup System – 40mm ID Inserts (various)Waldemar Link GmbH & Co. KG20260—
+5K252623G7® Revision Acetabular SystemZimmer, Inc.20260—
+5K253171Libertas Taper Short (TS) Uncemented Femoral Stem (Libertas TS Stem)Maxx Orthopedics, Inc.20260—
+5K252067Velora Acetabular SystemRestor3D, Inc.20250—
+5K252846TaperSet™ Hip SystemShalby Advanced Technologies, Inc. Dba Consensus Orthopedics20250—
+5K251833EMPOWR Acetabular® Liner ExtensionEncore Medical L.P.20250—
+5K243456ONVOY™ Acetabular SystemGlobus Medical, Inc.20250—
+5K243043Origin™ Cemented Hip StemSignature Orthopaedics Pty, Ltd.20250—
+5K242315Resolve Modular Revision Hip StemUnited Orthopedic Corporation20250—
+5K242232Mpact 3D Metal Augments IIMedacta International S.A.20250—
+5K242045Initia T3 Acetabular Hemispherical Shell SystemKyocera Medical Technologies, Inc.20250—
+5K243029Origin™ TT StemSignature Orthopaedics Pty, Ltd.20250—
+5K243444Bioceram Azul® HeadKyocera Corporation20240—
+5K241636MobileLink Acetabular Cup System - Line Extension (Multiple)Waldemar Link GmbH & Co. KG20242—
+5K241472Icona Hip StemCorin U.S.A. Limited20241—