510(k) Report

Devices descending from K921301

383 later devices reach Taperloc Femoral Stem and Universal Acetabular Com through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K183684Libertas – Taper Uncemented Femoral StemMaxx Orthopedics, Inc.20191—
+1K183532Latitud Hip Replacement SystemMeril Healthcare Pvt., Ltd.20190—
+1K121034Ioi Total HipIconacy Orthopedic Implants, LLC201211—
+1K121777U2 Acetabular Cup, Plasma SprayUnited Orthopedic Corp.201291
+1K110245United Utf StemUnited Orthopedic Corporation201171
+1K102399Consensus Taperset Hip SystemConsensus Orthopedics, Inc.201033—
+1K072101Rigi-Fix Hip Stem SystemImplants Intl., Ltd.20070—
+1K062775European Style Taper,Press-Fit Hip StemOrtho Development Corp.2007134
+1K061124Orthopedic Source Press-Fit HipOrthopedic Source, Inc.20060—
+1K050441Taper 2 Porous Femoral StemBiomet, Inc.200585—
+1K043537Taperloc 12/14 Taper Femoral ComponentsBiomet, Inc.2005160—
+1K032726Zimmer M/L Taper Hip Prosthesis, 7711 SeriesZimmer, Inc.2003843
+1K020963Taperloc Porous Femoral Stem & HA Taperloc Porous Lateralized Femoral StemBiomet Orthopedics, Inc.2002234—
+1K994366TMZF Press Fit HA Stem and TMZF Press Fit Plus HA StemHowmedica Osteonics Corp.2000763
+2K253171Libertas Taper Short (TS) Uncemented Femoral Stem (Libertas TS Stem)Maxx Orthopedics, Inc.20260—
+2K252846TaperSet™ Hip SystemShalby Advanced Technologies, Inc. Dba Consensus Orthopedics20250—
+2K242315Resolve Modular Revision Hip StemUnited Orthopedic Corporation20250—
+2K192660Zimmer M/L Taper Hip ProsthesisZimmer, Inc.20202—
+2K172251UTS StemUnited Orthopedic Corporation20171—
+2K163577Ecofit® Hip SystemImplantcast GmbH201791
+2K163193UTF Stem, reduced, #0, #00United Orthopedic Corporation20172—
+2K163585Responsive Orthopedics Total Hip Arthroplasty SystemResponsive Orthopedics, LLC20171—
+2K160895Initia Total Hip System & BIOCERAM AZUL (R) HEADKyocera Medical Corporation20162—
+2K161830Zimmer M/L Taper Hip ProsthesisZimmer, Inc.20160—
+2K153345Stryker Orthopaedics Hip Systems Labeling UpdateStryker Orthopaedics2016171
+2K160266ICONACY (TM) I-Hip (TM)Iconacy Orthopedic Implants, LLC20160—
+2K151307ICONACY (TM) I-Hip (TM)Iconacy Orthopedic Implants, LLC20166—
+2K150007Modified Bencox Hip SystemCorentec Co., Ltd.20157—
+2K142882G7 Freedom and Offset Liners, Freedom Head, Size 32Biomet, Inc.201517—
+2K141327Minima S SystemLima Corporate S.P.A.20145—
+2K141001Alpine Hip Stem; Alpine HA Hip StemOrtho Development20144—
+2K140975Mastersl Femoral StemLima Corporate S.P.A.20144—
+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—
+2K131022Ovation 10/12 Hip StemOrtho Development Corp.20135—
+2K131279Iconacy I-Hip SystemIconacy Orthopedic Implants, LLC20138—
+2K130149U2 Hip System, Expanded Indications for UseUnited Orthopedic Corporation20130—
+2K123619Intrablock Bioball Hip System (Ibs)Merete Medical GmbH20131—
+2K123550Utf Stem, ReducedUnited Orthopedic Corporation20134—
+2K122185U-Motion II Acetabular SystemUnited Orthopedic Corp.20137—
+2K121297Origin Hip Stem, Femoral Head, Logical PX-Series Acetabular Shell, Locigal G-Series…Signature Orthopaedics Pty, Ltd.2012202
+2K121874G7 Acetabular SystemBiomet Manufacturing Corp2012533
+2K122512CS2 Hip SystemConsensus Orthopedics, Inc.20123—
+2K121509Treasure Bipolar Head, Femoral Head, Treasure Bipolar Head, InsertTgm Medical, Inc.20120—
+2K121935Taperset Hip Small StemsConsensus Orthopedics, Inc.201220—
+2K112897Renovis Surgical Hip Joint Replacement ProsthesisRenovis Surgical Technologies, LLC20128—
+2K121263Taper Set Hip System RDP StemConsensus Orthopedics, Inc.20120—
+2K120578Accolade II Hip StemHowmedica Osteonics2012461
+2K112019Bencox ID Stem, Bencox Metal Head, Bencox Bipolar CupCorentec Co., Ltd.201110—
+2K111472Helicon Hip System, Femoral Stem, Helicon Hip System, Femoral Head, Cocr, Helicon Hip…Tgm Medical20114—
+2K110542Consensus Biolox Delta Ceramic Femoral HeadConsensus Orthopedics, Inc.20110—
+2K103479Novel Tapered Hip StemStryker Corp.201153—
+2K082446Biomet Metal-on-Metal Hip Systems- Expanded ContraindicationsBiomet, Inc.200821
+2K071723Zimmer Porolock Mis StemZimmer GmbH2008732
+2K062994Lateralized Taperloc Microplasty Femoral ComponentsBiomet Manufacturing Corp200784—
+2K063251Zimmer M/L Taper Hip Prosthesis with Modular Neck TechnologyZimmer, Inc.200754
+2K061423M2A Magnum 12/14 Taper Inserts and One-Piece Modular HeadsBiomet Manufacturing Corp20063—
+2K060040Zimmer M/L Taper Hip ProsthesisZimmer, Inc.200632
+2K052542Accolade RPS Hip StemStryker Orthopaedics20050—
+2K051741Accolade HFX Femoral StemStryker Orthopaedics200518—
+2K043079Bicontact Hip System with U-CapAesculap2004166—
+2K042337Zimmer M/L Taper Hip Prosthesis with Calcicoat Ceramic CoatingZimmer, Inc.200411—
+3K253948Momentum Acetabular Cup SystemUnited Orthopedic Corporation20260—
+3K252451EPORE® XO cup systemImplantcast GmbH20260—
+3K260037implantcast Packaging System UpdateImplantcast GmbH20260—
+3K252824Evolve AP Cup, World Finned Cup, World G-Zero Liner and Oddball Femoral HeadSignature Orthopaedics Pty, Ltd.20260—
+3K243043Origin™ Cemented Hip StemSignature Orthopaedics Pty, Ltd.20250—
+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—
+3K240834EcoFit® short stem cementless cpTiImplantcast GmbH20241—
+3K233498Stryker Orthopaedics Hip Systems Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics20234—
+3K231925MINIMA S SystemLima Corporate S.P.A.20230—
+3K223103BethaLoc® stem cementless HAImplantcast GmbH20231—
+3K231109Xerxes Hip StemXerxes Arthopedix, LLC20230—
+3K221149U-Motion II Acetabular System-Extension lineUnited Orthopedic Corporation20231—
+3K221675United U2 femoral head, 22mm delta ceramic headUnited Orthopedic Corporation20220—
+3K222632UHR Bipolar Implants, Restoration GAP II ImplantsHowmedica Osteonics Corp., Dba Stryker Orthopaedics20225—
+3K210678implaFit® hip stemsImplantcast GmbH20223—
+3K220731Insignia Hip Stem, Restoration Modular 115mm Conical Distal StemStryker20226—
+3K220838Artisan Bone Plug, Universal Cement RestrictorHowmedica Osteonics, Dba Stryker Orthopaedics20225—
+3K220468BENCOX Mirabo Cup SystemCorentec Co., Ltd.20221—
+3K212512G7® Vivacit-E® Freedom® Constrained LinerZimmer, Inc.20220—
+3K211703Insignia Hip StemStryker Orthopaedics20217—
+3K210893Restoration Anatomic ShellHowmedica Osteonics Corp. A.K.A. Stryker Orthopaedics20215—
+3K203420EcoFit® Hip SystemImplantcast GmbH20214—
+3K201673SMS Cementless StemMedacta International S.A.20203—
+3K191708Origin Stem, Evolve Stem, Aria Hip Stem, Remedy Stem, CoCr Femoral HeadSignature Orthopaedics Pty, Ltd.20200—
+3K193429Exeter V40 Femoral Stem, Exeter X3 RimFit CupHowmedica Osteonics Corp.202061
+3K200823Zimmer, Inc. Hip Joint Prostheses MR Labeling IZimmer, Inc.202011
+3K191826KeYi Total Hip SystemBeijing Keyi Medical Device Technology Co., Ltd.20200—
+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—
+3K192236Fitmore Hip StemZimmer GmbH20191—
+3K183457Zimmer Biomet 12/14 CoCr Femoral Head and Freedom HeadZimmer, Inc.20190—
+3K190704Signature Ceramic Femoral HeadSignature Orthopaedics Pty, Ltd.20192—
+3K183129Medtronic Total Hip Arthroplasty SystemMedtronic Advanced Energy20190—
+3K190057DJO Acetabular SystemEncore Medical L.P.201925