510(k) Report

Devices descending from K000760

238 later devices reach Reach Femoral Component through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K151603Arcos One-piece Femoral Revision SystemBiomet, Inc.20150—
+1K062978U2 Hip Stem, TI Plasma SprayUnited Orthopedic Corp.20071—
+1K041850Medallion Modular Hip SystemBiomet Manufacturing, Inc.20041—
+1K030055Mallory/Head Total Hip System; HA Mallory/Head Total Hip System; BI-Metric Femoral…Biomet, Inc.20032083
+1K031693Mallory/Head Modular Calcar with and Without HABiomet, Inc.20033916
+2K130149U2 Hip System, Expanded Indications for UseUnited Orthopedic Corporation20130—
+2K112897Renovis Surgical Hip Joint Replacement ProsthesisRenovis Surgical Technologies, LLC20128—
+2K090757Biomet Modular Femoral Revision SystemBiomet, Inc.20093718
+2K052089XR-Series BI-Metric Femoral ComponentsBiomet Manufacturing, Inc.20061—
+2K050124Porous Coated Acetabular ComponentsBiomet, Inc.20051381
+2K050251Balance Hip SystemBiomet, Inc.20052—
+2K042989RX90 Low Profile Acetabular SystemBiomet, Inc.20051—
+2K042774Mallory-Head Modular Calcar Stems with Interlocking SlotsBiomet, Inc.200538—
+2K043537Taperloc 12/14 Taper Femoral ComponentsBiomet, Inc.2005160—
+3K242315Resolve Modular Revision Hip StemUnited Orthopedic Corporation20250—
+3K183684Libertas – Taper Uncemented Femoral StemMaxx Orthopedics, Inc.20191—
+3K183532Latitud Hip Replacement SystemMeril Healthcare Pvt., Ltd.20190—
+3K171543Renovis Surgical Hip Replacement SystemRenovis Surgical Technologies20170—
+3K160895Initia Total Hip System & BIOCERAM AZUL (R) HEADKyocera Medical Corporation20162—
+3K152903REVIVAL (TM) Modular Revision Hip StemCorin USA20164—
+3K152621OSS/Arcos IM Total Femur RodBiomet, Inc.20150—
+3K143647Renovis Surgical Hip Replacement SystemRenovis Surgical Technologies, Inc.20151—
+3K150007Modified Bencox Hip SystemCorentec Co., Ltd.20157—
+3K142882G7 Freedom and Offset Liners, Freedom Head, Size 32Biomet, Inc.201517—
+3K143009Echo Bi-Metric Microplasty Hip SystemBiomet, Inc.20141—
+3K141676Renovis Surgical Porous Acetabular Cup SystemRenovis Surgical Technologies, Inc.20144—
+3K141327Minima S SystemLima Corporate S.P.A.20145—
+3K140975Mastersl Femoral StemLima Corporate S.P.A.20144—
+3K132312Renovis Tesera Trabecular Technology (T3) Acetabular Shell SystemRenovis Surgical Technologies, LLC20146—
+3K131022Ovation 10/12 Hip StemOrtho Development Corp.20135—
+3K123619Intrablock Bioball Hip System (Ibs)Merete Medical GmbH20131—
+3K130063Arcos Trochanter ButtonBiomet, Inc.20133—
+3K121297Origin Hip Stem, Femoral Head, Logical PX-Series Acetabular Shell, Locigal G-Series…Signature Orthopaedics Pty, Ltd.2012202
+3K121874G7 Acetabular SystemBiomet Manufacturing Corp2012533
+3K121034Ioi Total HipIconacy Orthopedic Implants, LLC201211—
+3K112019Bencox ID Stem, Bencox Metal Head, Bencox Bipolar CupCorentec Co., Ltd.201110—
+3K110245United Utf StemUnited Orthopedic Corporation201171
+3K100469Arcos Interlocking Distal StemsBiomet Manufacturing Corp20107—
+3K102399Consensus Taperset Hip SystemConsensus Orthopedics, Inc.201033—
+3K092331Djo Surgical Revision Femoral Hip System, Model 428-14/24-140/200; 428-00-050/110;Encore Medical L.P.2010271
+3K082446Biomet Metal-on-Metal Hip Systems- Expanded ContraindicationsBiomet, Inc.200821
+3K073637Parallel-Sided Extensively Coated Femoral StemsBiomet Manufacturing Corp20080—
+3K072101Rigi-Fix Hip Stem SystemImplants Intl., Ltd.20070—
+3K070369Regenerx Ringloc + Modular Acetabular ShellsBiomet, Inc.200713719
+3K062775European Style Taper,Press-Fit Hip StemOrtho Development Corp.2007134
+3K061423M2A Magnum 12/14 Taper Inserts and One-Piece Modular HeadsBiomet Manufacturing Corp20063—
+3K052255Arcomxl Polyethylene RX90 Acetabular LinersBiomet, Inc.20050—
+4K253948Momentum Acetabular Cup SystemUnited Orthopedic Corporation20260—
+4K252824Evolve AP Cup, World Finned Cup, World G-Zero Liner and Oddball Femoral HeadSignature Orthopaedics Pty, Ltd.20260—
+4K253171Libertas Taper Short (TS) Uncemented Femoral Stem (Libertas TS Stem)Maxx Orthopedics, Inc.20260—
+4K252846TaperSet™ Hip SystemShalby Advanced Technologies, Inc. Dba Consensus Orthopedics20250—
+4K243021Longboard Revision Hip StemSignature Orthopaedics Pty, Ltd.20250—
+4K243043Origin™ Cemented Hip StemSignature Orthopaedics Pty, Ltd.20250—
+4K242045Initia T3 Acetabular Hemispherical Shell SystemKyocera Medical Technologies, Inc.20250—
+4K243029Origin™ TT StemSignature Orthopaedics Pty, Ltd.20250—
+4K243444Bioceram Azul® HeadKyocera Corporation20240—
+4K241690Logical Liner; World Liner; World Knee PatellaSignature Orthopaedics Pty, Ltd.20242—
+4K231925MINIMA S SystemLima Corporate S.P.A.20230—
+4K231109Xerxes Hip StemXerxes Arthopedix, LLC20230—
+4K220468BENCOX Mirabo Cup SystemCorentec Co., Ltd.20221—
+4K212512G7® Vivacit-E® Freedom® Constrained LinerZimmer, Inc.20220—
+4K220405Amis K LongMedacta International S.A.20220—
+4K201657Corin Ltd. Hip Products: Trinity™ Acetabular System, Trinity™ PLUS Acetabular Shell…Corin, Ltd.20212—
+4K203472KMTI Hip Replacement SystemKyocera Medical Technologies, Inc.20210—
+4K191708Origin Stem, Evolve Stem, Aria Hip Stem, Remedy Stem, CoCr Femoral HeadSignature Orthopaedics Pty, Ltd.20200—
+4K201660KMTI Hip Replacement System, Tesera Trabecular Technologies (T3) Acetabular Shell…Kyocera Medical Technologies, Inc.20200—
+4K200328Tesera Trabecular Technologies (T3) Acetabular Shell System, Porous Acetabular Cup SystemKyocera Medical Technologies, Inc.20201—
+4K192559Acetabular Bone Screws (for MobileLink Acetabular Cup System)Waldemar Link GmbH & Co. KG20194—
+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—
+4K190100USTAR II SystemUnited Orthopedic Corporation201925
+4K190704Signature Ceramic Femoral HeadSignature Orthopaedics Pty, Ltd.20192—
+4K191374Revival Modular Hip StemCorin U.S.A. Limited20193—
+4K190057DJO Acetabular SystemEncore Medical L.P.201925
+4K182321MobileLink Acetabular Cup SystemWaldemar Link GmbH & Co. KG20198—
+4K181491Delta Dual Mobility SystemLima Corporate S.P.A.20190—
+4K182221Bencox Mirabo Cup Multi HoleCorentec Co., Ltd.20193—
+4K183582MPACT ExtensionMedacta International S.A.20194—
+4K173380b-ONE® Total Hip SystemB-One Ortho, Corp.20180—
+4K172251UTS StemUnited Orthopedic Corporation20171—
+4K172806Bencox Mirabo Cup SystemCorentec Co., Ltd.20174—
+4K163193UTF Stem, reduced, #0, #00United Orthopedic Corporation20172—
+4K163585Responsive Orthopedics Total Hip Arthroplasty SystemResponsive Orthopedics, LLC20171—
+4K162127Bencox M Stem Lateralized & Bencox Mirabo Cup SystemCorentec Co., Ltd.201661
+4K161610EXPRT Revision Hip SystemEncore Medical L.P.20161—
+4K161155Origin Coxa Vara Hip StemSignature Orthopaedics Pty, Ltd.201611
+4K153131Logical C-Series Acetabular Shell, Logical Constrained Liner, Logical Constrained Liner…Signature Orthopaedics Pty, Ltd.20164—
+4K160266ICONACY (TM) I-Hip (TM)Iconacy Orthopedic Implants, LLC20160—
+4K151307ICONACY (TM) I-Hip (TM)Iconacy Orthopedic Implants, LLC20166—
+4K151739Revision Femoral StemLima Corporate S.P.A.20157—
+4K150855H-MAX S Femoral Hip SystemLima Corporate S.P.A.20152—
+4K150503Echo Bi-Metric Microplasty Line ExtensionBiomet, Inc.20150—
+4K143184Evolve UniPolar HeadSignature Orthopaedics Pty, Ltd.20151—
+4K143509MasterSL femoral stemLima Corporate S.P.A.20153—
+4K142746G7 Finned Acetabular ShellBiomet Manufactuting Corp.20140—
+4K140669G7 Osseoti Acetublar ShellsBiomet, Inc.201435—
+4K141377Bioball Delta Ceramic Heads, Multicup PE Inlay StandardMerete Medical GmbH20140—
+4K141001Alpine Hip Stem; Alpine HA Hip StemOrtho Development20144—
+4K133370Remedy Hip Stem, Pegasus Hip Stem, Evolve Helios Hip Stem, Evolve Masters Hip Stem…Signature Orthopaedics Pty Limited20145—
+4K132697Encompass 10/12 Hip StemOrtho Development Corp.20140—