510(k) Report

Devices descending from K043537

160 later devices reach Taperloc 12/14 Taper Femoral Components through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K183684Libertas – Taper Uncemented Femoral StemMaxx Orthopedics, Inc.20191—
+1K183532Latitud Hip Replacement SystemMeril Healthcare Pvt., Ltd.20190—
+1K160895Initia Total Hip System & BIOCERAM AZUL (R) HEADKyocera Medical Corporation20162—
+1K150007Modified Bencox Hip SystemCorentec Co., Ltd.20157—
+1K142882G7 Freedom and Offset Liners, Freedom Head, Size 32Biomet, Inc.201517—
+1K141327Minima S SystemLima Corporate S.P.A.20145—
+1K140975Mastersl Femoral StemLima Corporate S.P.A.20144—
+1K131022Ovation 10/12 Hip StemOrtho Development Corp.20135—
+1K123619Intrablock Bioball Hip System (Ibs)Merete Medical GmbH20131—
+1K121297Origin Hip Stem, Femoral Head, Logical PX-Series Acetabular Shell, Locigal G-Series…Signature Orthopaedics Pty, Ltd.2012202
+1K121874G7 Acetabular SystemBiomet Manufacturing Corp2012533
+1K121034Ioi Total HipIconacy Orthopedic Implants, LLC201211—
+1K112897Renovis Surgical Hip Joint Replacement ProsthesisRenovis Surgical Technologies, LLC20128—
+1K112019Bencox ID Stem, Bencox Metal Head, Bencox Bipolar CupCorentec Co., Ltd.201110—
+1K110245United Utf StemUnited Orthopedic Corporation201171
+1K102399Consensus Taperset Hip SystemConsensus Orthopedics, Inc.201033—
+1K082446Biomet Metal-on-Metal Hip Systems- Expanded ContraindicationsBiomet, Inc.200821
+1K072101Rigi-Fix Hip Stem SystemImplants Intl., Ltd.20070—
+1K062775European Style Taper,Press-Fit Hip StemOrtho Development Corp.2007134
+1K061423M2A Magnum 12/14 Taper Inserts and One-Piece Modular HeadsBiomet Manufacturing Corp20063—
+2K253948Momentum Acetabular Cup SystemUnited Orthopedic Corporation20260—
+2K252824Evolve AP Cup, World Finned Cup, World G-Zero Liner and Oddball Femoral HeadSignature Orthopaedics Pty, Ltd.20260—
+2K253171Libertas Taper Short (TS) Uncemented Femoral Stem (Libertas TS Stem)Maxx Orthopedics, Inc.20260—
+2K252846TaperSet™ Hip SystemShalby Advanced Technologies, Inc. Dba Consensus Orthopedics20250—
+2K243043Origin™ Cemented Hip StemSignature Orthopaedics Pty, Ltd.20250—
+2K242315Resolve Modular Revision Hip StemUnited Orthopedic Corporation20250—
+2K242045Initia T3 Acetabular Hemispherical Shell SystemKyocera Medical Technologies, Inc.20250—
+2K243029Origin™ TT StemSignature Orthopaedics Pty, Ltd.20250—
+2K243444Bioceram Azul® HeadKyocera Corporation20240—
+2K241690Logical Liner; World Liner; World Knee PatellaSignature Orthopaedics Pty, Ltd.20242—
+2K231925MINIMA S SystemLima Corporate S.P.A.20230—
+2K231109Xerxes Hip StemXerxes Arthopedix, LLC20230—
+2K220468BENCOX Mirabo Cup SystemCorentec Co., Ltd.20221—
+2K212512G7® Vivacit-E® Freedom® Constrained LinerZimmer, Inc.20220—
+2K191708Origin Stem, Evolve Stem, Aria Hip Stem, Remedy Stem, CoCr Femoral HeadSignature Orthopaedics Pty, Ltd.20200—
+2K192559Acetabular Bone Screws (for MobileLink Acetabular Cup System)Waldemar Link GmbH & Co. KG20194—
+2K190660G7 Acetabular System Longevity Highly Crosslinked Polyethylene, G7 Acetabular System…Zimmer, Inc.20194—
+2K183457Zimmer Biomet 12/14 CoCr Femoral Head and Freedom HeadZimmer, Inc.20190—
+2K190704Signature Ceramic Femoral HeadSignature Orthopaedics Pty, Ltd.20192—
+2K190057DJO Acetabular SystemEncore Medical L.P.201925
+2K182321MobileLink Acetabular Cup SystemWaldemar Link GmbH & Co. KG20198—
+2K182221Bencox Mirabo Cup Multi HoleCorentec Co., Ltd.20193—
+2K183582MPACT ExtensionMedacta International S.A.20194—
+2K173380b-ONE® Total Hip SystemB-One Ortho, Corp.20180—
+2K171543Renovis Surgical Hip Replacement SystemRenovis Surgical Technologies20170—
+2K172251UTS StemUnited Orthopedic Corporation20171—
+2K172806Bencox Mirabo Cup SystemCorentec Co., Ltd.20174—
+2K163193UTF Stem, reduced, #0, #00United Orthopedic Corporation20172—
+2K163585Responsive Orthopedics Total Hip Arthroplasty SystemResponsive Orthopedics, LLC20171—
+2K162127Bencox M Stem Lateralized & Bencox Mirabo Cup SystemCorentec Co., Ltd.201661
+2K161155Origin Coxa Vara Hip StemSignature Orthopaedics Pty, Ltd.201611
+2K153131Logical C-Series Acetabular Shell, Logical Constrained Liner, Logical Constrained Liner…Signature Orthopaedics Pty, Ltd.20164—
+2K160266ICONACY (TM) I-Hip (TM)Iconacy Orthopedic Implants, LLC20160—
+2K151307ICONACY (TM) I-Hip (TM)Iconacy Orthopedic Implants, LLC20166—
+2K150855H-MAX S Femoral Hip SystemLima Corporate S.P.A.20152—
+2K143647Renovis Surgical Hip Replacement SystemRenovis Surgical Technologies, Inc.20151—
+2K143184Evolve UniPolar HeadSignature Orthopaedics Pty, Ltd.20151—
+2K143509MasterSL femoral stemLima Corporate S.P.A.20153—
+2K142746G7 Finned Acetabular ShellBiomet Manufactuting Corp.20140—
+2K140669G7 Osseoti Acetublar ShellsBiomet, Inc.201435—
+2K141377Bioball Delta Ceramic Heads, Multicup PE Inlay StandardMerete Medical GmbH20140—
+2K141676Renovis Surgical Porous Acetabular Cup SystemRenovis Surgical Technologies, Inc.20144—
+2K141001Alpine Hip Stem; Alpine HA Hip StemOrtho Development20144—
+2K133370Remedy Hip Stem, Pegasus Hip Stem, Evolve Helios Hip Stem, Evolve Masters Hip Stem…Signature Orthopaedics Pty Limited20145—
+2K132697Encompass 10/12 Hip StemOrtho Development Corp.20140—
+2K132312Renovis Tesera Trabecular Technology (T3) Acetabular Shell SystemRenovis Surgical Technologies, LLC20146—
+2K132572I-Hip Total Hip SystemIconacy Orthopedic Implants, LLC20147—
+2K133386Ovation Tribute Hip Stem; Ovation Narrow Hip StemOrtho Development Corp.20143—
+2K133228Iconacy I-Hip System, Gradual Transitioning (GT) Femoral SystemIconacy Orthopedic Implants, LLC20147—
+2K131279Iconacy I-Hip SystemIconacy Orthopedic Implants, LLC20138—
+2K123550Utf Stem, ReducedUnited Orthopedic Corporation20134—
+2K122512CS2 Hip SystemConsensus Orthopedics, Inc.20123—
+2K121509Treasure Bipolar Head, Femoral Head, Treasure Bipolar Head, InsertTgm Medical, Inc.20120—
+2K122099Bencox II Stem, Bencox Metal HeadCorentec Co., Ltd.20120—
+2K121665Bencox Foret & Bencox DeltaCorentec Co., Ltd.20128—
+2K121935Taperset Hip Small StemsConsensus Orthopedics, Inc.201220—
+2K121263Taper Set Hip System RDP StemConsensus Orthopedics, Inc.20120—
+2K113271Metal-on-Metal Hip Systems-Additional ContraindicationsBiomet Manufacturing, Inc.20120—
+2K111472Helicon Hip System, Femoral Stem, Helicon Hip System, Femoral Head, Cocr, Helicon Hip…Tgm Medical20114—
+2K110542Consensus Biolox Delta Ceramic Femoral HeadConsensus Orthopedics, Inc.20110—
+2K083642Depuy Pinnacle Metal-on-Metal Acetabular Cup LinersDePuy Orthopaedics, Inc.20090—
+3K261453G7® Acetabular SystemZimmer Biomet20260—
+3K261009MobileLink Acetabular Cup System – 40mm ID Inserts (various)Waldemar Link GmbH & Co. KG20260—
+3K252623G7® Revision Acetabular SystemZimmer, Inc.20260—
+3K252067Velora Acetabular SystemRestor3D, Inc.20250—
+3K251833EMPOWR Acetabular® Liner ExtensionEncore Medical L.P.20250—
+3K243456ONVOY™ Acetabular SystemGlobus Medical, Inc.20250—
+3K243162World LinerSignature Orthopaedics Pty, Ltd.20240—
+3K241636MobileLink Acetabular Cup System - Line Extension (Multiple)Waldemar Link GmbH & Co. KG20242—
+3K240452Ceramic Femoral HeadMicroport Orthopedics, Inc.20240—
+3K230011Mpact ExtensionMedacta International S.A.20233—
+3K222066LINK MobileLink Acetabular Cup SystemWaldemar Link GmbH & Co. KG20230—
+3K223223BENCOX Mirabo Z Cup CortiniumCorentec Co., Ltd.20230—
+3K221479Persona Personalized Knee SystemZimmer, Inc.20228—
+3K210614BENCOX Mirabo Z Cup CortiniumCorentec Co., Ltd.20221—
+3K211866Bencox THR SystemCorentec Co., Ltd.20210—
+3K200607LINK MobileLink® Acetabular Cup System - Dual Mobility Liners, and Shell/Insert AdaptersWaldemar Link GmbH & Co. KG202111
+3K201047Fusion Taper SystemSignature Orthopaedics Pty, Ltd.20210—
+3K203472KMTI Hip Replacement SystemKyocera Medical Technologies, Inc.20210—
+3K201660KMTI Hip Replacement System, Tesera Trabecular Technologies (T3) Acetabular Shell…Kyocera Medical Technologies, Inc.20200—