510(k) Report

Devices descending from K030055

208 later devices reach Mallory/Head Total Hip System; HA Mallory/Head Total Hip System; BI-Metric… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K112897Renovis Surgical Hip Joint Replacement ProsthesisRenovis Surgical Technologies, LLC20128—
+1K052089XR-Series BI-Metric Femoral ComponentsBiomet Manufacturing, Inc.20061—
+1K050124Porous Coated Acetabular ComponentsBiomet, Inc.20051381
+1K050251Balance Hip SystemBiomet, Inc.20052—
+1K042989RX90 Low Profile Acetabular SystemBiomet, Inc.20051—
+1K043537Taperloc 12/14 Taper Femoral ComponentsBiomet, Inc.2005160—
+2K183684Libertas – Taper Uncemented Femoral StemMaxx Orthopedics, Inc.20191—
+2K183532Latitud Hip Replacement SystemMeril Healthcare Pvt., Ltd.20190—
+2K171543Renovis Surgical Hip Replacement SystemRenovis Surgical Technologies20170—
+2K160895Initia Total Hip System & BIOCERAM AZUL (R) HEADKyocera Medical Corporation20162—
+2K143647Renovis Surgical Hip Replacement SystemRenovis Surgical Technologies, Inc.20151—
+2K150007Modified Bencox Hip SystemCorentec Co., Ltd.20157—
+2K142882G7 Freedom and Offset Liners, Freedom Head, Size 32Biomet, Inc.201517—
+2K143009Echo Bi-Metric Microplasty Hip SystemBiomet, Inc.20141—
+2K141676Renovis Surgical Porous Acetabular Cup SystemRenovis Surgical Technologies, Inc.20144—
+2K141327Minima S SystemLima Corporate S.P.A.20145—
+2K140975Mastersl Femoral StemLima Corporate S.P.A.20144—
+2K132312Renovis Tesera Trabecular Technology (T3) Acetabular Shell SystemRenovis Surgical Technologies, LLC20146—
+2K131022Ovation 10/12 Hip StemOrtho Development Corp.20135—
+2K123619Intrablock Bioball Hip System (Ibs)Merete Medical GmbH20131—
+2K121297Origin Hip Stem, Femoral Head, Logical PX-Series Acetabular Shell, Locigal G-Series…Signature Orthopaedics Pty, Ltd.2012202
+2K121874G7 Acetabular SystemBiomet Manufacturing Corp2012533
+2K121034Ioi Total HipIconacy Orthopedic Implants, LLC201211—
+2K112019Bencox ID Stem, Bencox Metal Head, Bencox Bipolar CupCorentec Co., Ltd.201110—
+2K110245United Utf StemUnited Orthopedic Corporation201171
+2K102399Consensus Taperset Hip SystemConsensus Orthopedics, Inc.201033—
+2K082446Biomet Metal-on-Metal Hip Systems- Expanded ContraindicationsBiomet, Inc.200821
+2K073637Parallel-Sided Extensively Coated Femoral StemsBiomet Manufacturing Corp20080—
+2K072101Rigi-Fix Hip Stem SystemImplants Intl., Ltd.20070—
+2K070369Regenerx Ringloc + Modular Acetabular ShellsBiomet, Inc.200713719
+2K062775European Style Taper,Press-Fit Hip StemOrtho Development Corp.2007134
+2K061423M2A Magnum 12/14 Taper Inserts and One-Piece Modular HeadsBiomet Manufacturing Corp20063—
+2K052255Arcomxl Polyethylene RX90 Acetabular LinersBiomet, Inc.20050—
+3K253948Momentum Acetabular Cup SystemUnited Orthopedic Corporation20260—
+3K252824Evolve AP Cup, World Finned Cup, World G-Zero Liner and Oddball Femoral HeadSignature Orthopaedics Pty, Ltd.20260—
+3K253171Libertas Taper Short (TS) Uncemented Femoral Stem (Libertas TS Stem)Maxx Orthopedics, Inc.20260—
+3K252846TaperSet™ Hip SystemShalby Advanced Technologies, Inc. Dba Consensus Orthopedics20250—
+3K243043Origin™ Cemented Hip StemSignature Orthopaedics Pty, Ltd.20250—
+3K242315Resolve Modular Revision Hip StemUnited Orthopedic Corporation20250—
+3K242045Initia T3 Acetabular Hemispherical Shell SystemKyocera Medical Technologies, Inc.20250—
+3K243029Origin™ TT StemSignature Orthopaedics Pty, Ltd.20250—
+3K243444Bioceram Azul® HeadKyocera Corporation20240—
+3K241690Logical Liner; World Liner; World Knee PatellaSignature Orthopaedics Pty, Ltd.20242—
+3K231925MINIMA S SystemLima Corporate S.P.A.20230—
+3K231109Xerxes Hip StemXerxes Arthopedix, LLC20230—
+3K220468BENCOX Mirabo Cup SystemCorentec Co., Ltd.20221—
+3K212512G7® Vivacit-E® Freedom® Constrained LinerZimmer, Inc.20220—
+3K203472KMTI Hip Replacement SystemKyocera Medical Technologies, Inc.20210—
+3K191708Origin Stem, Evolve Stem, Aria Hip Stem, Remedy Stem, CoCr Femoral HeadSignature Orthopaedics Pty, Ltd.20200—
+3K201660KMTI Hip Replacement System, Tesera Trabecular Technologies (T3) Acetabular Shell…Kyocera Medical Technologies, Inc.20200—
+3K200328Tesera Trabecular Technologies (T3) Acetabular Shell System, Porous Acetabular Cup SystemKyocera Medical Technologies, Inc.20201—
+3K192559Acetabular Bone Screws (for MobileLink Acetabular Cup System)Waldemar Link GmbH & Co. KG20194—
+3K190660G7 Acetabular System Longevity Highly Crosslinked Polyethylene, G7 Acetabular System…Zimmer, Inc.20194—
+3K183457Zimmer Biomet 12/14 CoCr Femoral Head and Freedom HeadZimmer, Inc.20190—
+3K190704Signature Ceramic Femoral HeadSignature Orthopaedics Pty, Ltd.20192—
+3K190057DJO Acetabular SystemEncore Medical L.P.201925
+3K182321MobileLink Acetabular Cup SystemWaldemar Link GmbH & Co. KG20198—
+3K181491Delta Dual Mobility SystemLima Corporate S.P.A.20190—
+3K182221Bencox Mirabo Cup Multi HoleCorentec Co., Ltd.20193—
+3K183582MPACT ExtensionMedacta International S.A.20194—
+3K173380b-ONE® Total Hip SystemB-One Ortho, Corp.20180—
+3K172251UTS StemUnited Orthopedic Corporation20171—
+3K172806Bencox Mirabo Cup SystemCorentec Co., Ltd.20174—
+3K163193UTF Stem, reduced, #0, #00United Orthopedic Corporation20172—
+3K163585Responsive Orthopedics Total Hip Arthroplasty SystemResponsive Orthopedics, LLC20171—
+3K162127Bencox M Stem Lateralized & Bencox Mirabo Cup SystemCorentec Co., Ltd.201661
+3K161155Origin Coxa Vara Hip StemSignature Orthopaedics Pty, Ltd.201611
+3K153131Logical C-Series Acetabular Shell, Logical Constrained Liner, Logical Constrained Liner…Signature Orthopaedics Pty, Ltd.20164—
+3K160266ICONACY (TM) I-Hip (TM)Iconacy Orthopedic Implants, LLC20160—
+3K151307ICONACY (TM) I-Hip (TM)Iconacy Orthopedic Implants, LLC20166—
+3K150855H-MAX S Femoral Hip SystemLima Corporate S.P.A.20152—
+3K150503Echo Bi-Metric Microplasty Line ExtensionBiomet, Inc.20150—
+3K143184Evolve UniPolar HeadSignature Orthopaedics Pty, Ltd.20151—
+3K143509MasterSL femoral stemLima Corporate S.P.A.20153—
+3K142746G7 Finned Acetabular ShellBiomet Manufactuting Corp.20140—
+3K140669G7 Osseoti Acetublar ShellsBiomet, Inc.201435—
+3K141377Bioball Delta Ceramic Heads, Multicup PE Inlay StandardMerete Medical GmbH20140—
+3K141001Alpine Hip Stem; Alpine HA Hip StemOrtho Development20144—
+3K133370Remedy Hip Stem, Pegasus Hip Stem, Evolve Helios Hip Stem, Evolve Masters Hip Stem…Signature Orthopaedics Pty Limited20145—
+3K132697Encompass 10/12 Hip StemOrtho Development Corp.20140—
+3K132572I-Hip Total Hip SystemIconacy Orthopedic Implants, LLC20147—
+3K133386Ovation Tribute Hip Stem; Ovation Narrow Hip StemOrtho Development Corp.20143—
+3K133228Iconacy I-Hip System, Gradual Transitioning (GT) Femoral SystemIconacy Orthopedic Implants, LLC20147—
+3K131279Iconacy I-Hip SystemIconacy Orthopedic Implants, LLC20138—
+3K123550Utf Stem, ReducedUnited Orthopedic Corporation20134—
+3K112898Delta TT Cups, Delta TT Liners, Bone ScrewsLima Corporate S.P.A.201212—
+3K122512CS2 Hip SystemConsensus Orthopedics, Inc.20123—
+3K121509Treasure Bipolar Head, Femoral Head, Treasure Bipolar Head, InsertTgm Medical, Inc.20120—
+3K122099Bencox II Stem, Bencox Metal HeadCorentec Co., Ltd.20120—
+3K121665Bencox Foret & Bencox DeltaCorentec Co., Ltd.20128—
+3K121935Taperset Hip Small StemsConsensus Orthopedics, Inc.201220—
+3K121263Taper Set Hip System RDP StemConsensus Orthopedics, Inc.20120—
+3K113271Metal-on-Metal Hip Systems-Additional ContraindicationsBiomet Manufacturing, Inc.20120—
+3K112802Pipeline Total Hip SystemPipeline Orthopedics201253—
+3K111472Helicon Hip System, Femoral Stem, Helicon Hip System, Femoral Head, Cocr, Helicon Hip…Tgm Medical20114—
+3K110542Consensus Biolox Delta Ceramic Femoral HeadConsensus Orthopedics, Inc.20110—
+3K093235Ringloc + Hybrid Acetabular SystemBiomet, Inc.20106530
+3K083642Depuy Pinnacle Metal-on-Metal Acetabular Cup LinersDePuy Orthopaedics, Inc.20090—
+4K261453G7® Acetabular SystemZimmer Biomet20260—
+4K261009MobileLink Acetabular Cup System – 40mm ID Inserts (various)Waldemar Link GmbH & Co. KG20260—