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
+5K241690Logical Liner; World Liner; World Knee PatellaSignature Orthopaedics Pty, Ltd.20242—
+5K233498Stryker Orthopaedics Hip Systems Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics20234—
+5K231109Xerxes Hip StemXerxes Arthopedix, LLC20230—
+5K222066LINK MobileLink Acetabular Cup SystemWaldemar Link GmbH & Co. KG20230—
+5K221479Persona Personalized Knee SystemZimmer, Inc.20228—
+5K222632UHR Bipolar Implants, Restoration GAP II ImplantsHowmedica Osteonics Corp., Dba Stryker Orthopaedics20225—
+5K220731Insignia Hip Stem, Restoration Modular 115mm Conical Distal StemStryker20226—
+5K210614BENCOX Mirabo Z Cup CortiniumCorentec Co., Ltd.20221—
+5K220838Artisan Bone Plug, Universal Cement RestrictorHowmedica Osteonics, Dba Stryker Orthopaedics20225—
+5K220468BENCOX Mirabo Cup SystemCorentec Co., Ltd.20221—
+5K200607LINK MobileLink® Acetabular Cup System - Dual Mobility Liners, and Shell/Insert AdaptersWaldemar Link GmbH & Co. KG202111
+5K210893Restoration Anatomic ShellHowmedica Osteonics Corp. A.K.A. Stryker Orthopaedics20215—
+5K193429Exeter V40 Femoral Stem, Exeter X3 RimFit CupHowmedica Osteonics Corp.202061
+5K200656Delta Multihole TT Pro Acetabular SystemLima Corporate S.P.A.20200—
+5K192559Acetabular Bone Screws (for MobileLink Acetabular Cup System)Waldemar Link GmbH & Co. KG20194—
+5K191622Delta Multihole TT Pro Acetabular SystemLima Corporate S.P.A.20192—
+5K190704Signature Ceramic Femoral HeadSignature Orthopaedics Pty, Ltd.20192—
+5K190535BiMobile Dual Mobility System - E-Dur InsertsWaldemar Link GmbH & Co. KG201931
+5K182468Trident X3 Acetabular Inserts, ADM and MDM X3 Acetabular Inserts, Accolade II Hip SystemHowmedica Osteonics Corp. A.K.A. Stryker Orthopaedics20197—
+5K182099Delta TT ProLima Corporate S.P.A.20183—
+5K172551Trinity PLUS Acetabular ShellCorin U.S.A. Limited20184—
+5K173499Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral HeadsStryker Orthopaedics201882
+5K171543Renovis Surgical Hip Replacement SystemRenovis Surgical Technologies20170—
+5K172251UTS StemUnited Orthopedic Corporation20171—
+5K172806Bencox Mirabo Cup SystemCorentec Co., Ltd.20174—
+5K163193UTF Stem, reduced, #0, #00United Orthopedic Corporation20172—
+5K163585Responsive Orthopedics Total Hip Arthroplasty SystemResponsive Orthopedics, LLC20171—
+5K162127Bencox M Stem Lateralized & Bencox Mirabo Cup SystemCorentec Co., Ltd.201661
+5K161155Origin Coxa Vara Hip StemSignature Orthopaedics Pty, Ltd.201611
+5K153131Logical C-Series Acetabular Shell, Logical Constrained Liner, Logical Constrained Liner…Signature Orthopaedics Pty, Ltd.20164—
+5K160266ICONACY (TM) I-Hip (TM)Iconacy Orthopedic Implants, LLC20160—
+5K151307ICONACY (TM) I-Hip (TM)Iconacy Orthopedic Implants, LLC20166—
+5K142814Biomet Orthopaedic Salvage System (OSSTM) - Proximal Femoral & Hybrid TibialBiomet Manufacturing, LLC201516
+5K143647Renovis Surgical Hip Replacement SystemRenovis Surgical Technologies, Inc.20151—
+5K143184Evolve UniPolar HeadSignature Orthopaedics Pty, Ltd.20151—
+5K141377Bioball Delta Ceramic Heads, Multicup PE Inlay StandardMerete Medical GmbH20140—
+5K141676Renovis Surgical Porous Acetabular Cup SystemRenovis Surgical Technologies, Inc.20144—
+5K141001Alpine Hip Stem; Alpine HA Hip StemOrtho Development20144—
+5K133370Remedy Hip Stem, Pegasus Hip Stem, Evolve Helios Hip Stem, Evolve Masters Hip Stem…Signature Orthopaedics Pty Limited20145—
+5K132697Encompass 10/12 Hip StemOrtho Development Corp.20140—
+5K132312Renovis Tesera Trabecular Technology (T3) Acetabular Shell SystemRenovis Surgical Technologies, LLC20146—
+5K132572I-Hip Total Hip SystemIconacy Orthopedic Implants, LLC20147—
+5K133386Ovation Tribute Hip Stem; Ovation Narrow Hip StemOrtho Development Corp.20143—
+5K133228Iconacy I-Hip System, Gradual Transitioning (GT) Femoral SystemIconacy Orthopedic Implants, LLC20147—
+5K131279Iconacy I-Hip SystemIconacy Orthopedic Implants, LLC20138—
+5K123550Utf Stem, ReducedUnited Orthopedic Corporation20134—
+5K122512CS2 Hip SystemConsensus Orthopedics, Inc.20123—
+5K121509Treasure Bipolar Head, Femoral Head, Treasure Bipolar Head, InsertTgm Medical, Inc.20120—
+5K122099Bencox II Stem, Bencox Metal HeadCorentec Co., Ltd.20120—
+5K121665Bencox Foret & Bencox DeltaCorentec Co., Ltd.20128—
+5K121935Taperset Hip Small StemsConsensus Orthopedics, Inc.201220—
+5K121263Taper Set Hip System RDP StemConsensus Orthopedics, Inc.20120—
+5K113271Metal-on-Metal Hip Systems-Additional ContraindicationsBiomet Manufacturing, Inc.20120—
+5K111472Helicon Hip System, Femoral Stem, Helicon Hip System, Femoral Head, Cocr, Helicon Hip…Tgm Medical20114—
+5K110542Consensus Biolox Delta Ceramic Femoral HeadConsensus Orthopedics, Inc.20110—
+5K083642Depuy Pinnacle Metal-on-Metal Acetabular Cup LinersDePuy Orthopaedics, Inc.20090—
+6K253515Zimmer Biomet OSS™ Orthopedic Salvage System OsseoTi® Sleeves and AugmentsBiomet Orthopedics, Inc.20260—
+6K261576Icona Hip StemCorin, Ltd.20260—
+6K251840Zimmer® Persona® Personalized Knee SystemZimmer, Inc.20260—
+6K253189Persona the Personalized Knee System (Persona Porous Plasma Spray PPS Femurs)Zimmer, Inc.20260—
+6K250375Allure Hip Stem and Intramedullary PlugsWaldemar Link GmbH & Co. KG20250—
+6K250989Stryker and Serf hip devicesHowmedica Osteonics Corp (Dba Stryker Orthopaedics)20250—
+6K242744Trinity EVO Acetabular ShellCorin U.S.A. Limited20250—
+6K243927MobileLink Acetabular Cup System - inhouse coatingsWaldemar Link GmbH & Co. KG20250—
+6K243784Stryker Orthopaedics Hip Devices Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics20252—
+6K243162World LinerSignature Orthopaedics Pty, Ltd.20240—
+6K242543Persona the Personalized Knee System (Persona Ti-Nidium PPS Femurs)Zimmer, Inc.20240—
+6K240299Persona the Personalized Knee System (Persona OsseoTi 3-Peg Patella)Zimmer, Inc.20243—
+6K240452Ceramic Femoral HeadMicroport Orthopedics, Inc.20240—
+6K240418Stryker Orthopaedics Hip Systems Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics20240—
+6K23372428mm/38D MDM X3 Insert for MDM LinerHowmedica Osteonics Corp., Dba Stryker Orthopaedics20240—
+6K230321Persona™ Personalized Knee SystemZimmer, Inc.20230—
+6K223223BENCOX Mirabo Z Cup CortiniumCorentec Co., Ltd.20230—
+6K211567BiMobile Instruments (for BiMobile Dual Mobility System)Waldemar Link GmbH & Co. KG20220—
+6K213701Exeter® X3® RimFit® CupHowmedica Osteonics Corp., Dba Stryker Orthopaedics20225—
+6K211866Bencox THR SystemCorentec Co., Ltd.20210—
+6K201047Fusion Taper SystemSignature Orthopaedics Pty, Ltd.20210—
+6K203472KMTI Hip Replacement SystemKyocera Medical Technologies, Inc.20210—
+6K201660KMTI Hip Replacement System, Tesera Trabecular Technologies (T3) Acetabular Shell…Kyocera Medical Technologies, Inc.20200—
+6K192024Cemented TSI Hip StemSignature Orthopaedics Pty, Ltd.20200—
+6K191826KeYi Total Hip SystemBeijing Keyi Medical Device Technology Co., Ltd.20200—
+6K200328Tesera Trabecular Technologies (T3) Acetabular Shell System, Porous Acetabular Cup SystemKyocera Medical Technologies, Inc.20201—
+6K191414EXETER Centralizer, EXETER 2.5mm PlugStryker Orthopaedics20195—
+6K183129Medtronic Total Hip Arthroplasty SystemMedtronic Advanced Energy20190—
+6K181171Zimmer Biomet Ceramic HeadsZimmer, Inc.201925
+6K173880Corin TriFit CF Hip StemCorin U.S.A. Limited20183—
+6K171249Entrada™ hip stemOrtho Development Corporation20172—
+6K161184iNSitu Total Hip SystemTheken Companies, LLC201619—
+6K150576TGM Biolox delta Ceramic HeadsTgm Medical, Inc.20150—
+6K132207Utf Stem-Reduced, Additional SizesUnited Orthopedic Corporation20133—
+6K123782Paragon Hip SystemGlobal Manufacturing Technology20132—
+6K121636Zenith, Femoral Stem Zenith, Distal Centralizer Fomoral Head Acetabular InsertTgm Medical, Inc.20121—
+7K243192iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with Plasma Sprayed CPTi…Nextstep Arthopedix, LLC20260—
+7K243293Zimmer® Persona® Personalized Knee SystemZimmer Biomet20241—
+7K243247Persona the Personalized Knee SystemZimmer, Inc.20240—
+7K241875TheRay Collared and Collarless Femoral StemNextstep Arthropedix202411
+7K233758Trivicta™ Hip StemOrtho Development Corp.20241—
+7K220336Mg-PSZ Ceramic Femoral HeadTheken Companies20220—
+7K192071iNSitu Total Hip SystemTheken Companies, LLC20194—
+7K191936iNSitu Total Hip SystemThecken Companies, LLC20192—