510(k) Report

Devices descending from K971206

255 later devices reach Meridian ST Femoral Stem and Vitalock Solid Back Shell W/ Peri-Apatite Coating through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K122158PBP Total Hip SystemPipeline Biomedical Products, LLC201221—
+1K101072Tritanium Peri-Apatitie Acetabular Solid-Backed Shell, Tritanium Peri-ApatiteHowmedica Osteonics Corp.201122—
+1K023302Echelon Porous Plus HA Hip StemsSmith & Nephew, Inc.200225—
+1K013475Trident Porous Titanium Acetabular Component with Peri-Apatite CoatingHowmedica Osteonics Corp.2001216—
+1K982248Howmedica Asymmetric Stem Vitalock Cluster & Spiked Shells, and Acetabular Shells with…Howmedica, Inc.19980—
+2K211176Smith & Nephew Hip SystemsSmith & Nephew, Inc.202231
+2K123598Smith & Nephew, Inc. Hip System InstrumentationSmith & Nephew, Inc.201302
+2K131237Pipeline Total Hip SystemPipeline Orthopedics201320—
+2K042344Excia Total Hip SystemAesculap, Inc.200519810
+2K040412Trident T Acetabular ShellsStryker Orthopaedics200423—
+2K032683Genesis II Porous Plus HA Knee SystemSmith & Nephew, Inc.200319—
+3K240783Anthology Hip Stems; CPCS Hip Stems; Femoral Heads; R3 Acetabular Liners; Spectron Hip…Smith & Nephew, Inc.20240—
+3K242375OR3O Dual Mobility SystemSmith & Nephew, Inc.20240—
+3K231448TANDEM Hip SystemSmith & Nephew, Inc.202301
+3K190577World Knee Total Knee SystemsSignature Orthopaedics Pty, Ltd.20195—
+3K190057DJO Acetabular SystemEncore Medical L.P.201925
+3K180263EcoFit Vit E Acetabular SystemImplantcast GmbH20185—
+3K172235CoreHip® SystemAesculap Implants Systems, LLC20180—
+3K163577Ecofit® Hip SystemImplantcast GmbH201791
+3K162125MALUC™ Total Hip Arthroplasty SystemSurgtech, Inc.20170—
+3K161184iNSitu Total Hip SystemTheken Companies, LLC201619—
+3K153345Stryker Orthopaedics Hip Systems Labeling UpdateStryker Orthopaedics2016171
+3K122783Plasmafit Acetabular Cup and Vitelene InsertAesculap Implant System, Inc.20130—
+3K121393Smith & Nephew, Inc. Total Knee System InstrumentationSmith & Nephew, Inc.201254
+3K103431Coren Total Hip SystemCorentec Co., Ltd.201111—
+3K100897Legion Porous + HA Tibial BaseplatesSmith & Nephew, Inc.201012—
+3K092143Excia Total Hip System M an ML Femoral StemAesculap Implant Systems, Inc.20093—
+3K090299Biolox Option Ceramic Femoral Head and Metha XL HeadsAesculap Implant Systems20091—
+3K082991Biolox Delta Ceramic Femoral HeadAesculap Implant Systems, Inc.200863—
+3K081973Metha Short Stem Hip System; Modular Hip System; Excia Hip SystemAesculap Implant Systems, Inc.20082—
+3K071916Metha Hip SystemAesculap Implant Systems, Inc.2008681
+3K080584Metha Short Stem Hip SystemAesculap Implant System, Inc.200883—
+3K070981Search Evolution (LC) Total Knee System (Plasmapore)Aesculap Implant Systems, Inc.200779—
+3K071583Cermet Iii Acetabular Cup SystemImplants International, Ltd.20070—
+3K062684Excia Total Hip System 36MM Ceramic HeadAesculap, Inc.200665—
+3K061344Excia Total Hip System Lateral OffsetAesculap, Inc.20064—
+3K060707Aesculap Bipolar Acetabular CupAesculap, Inc.200611—
+3K060918Excia Total Hip System 12/14 Trunnion with Ceramic HeadAesculap, Inc.200690—
+3K060437Excia Total Hip System with U-CapAesculap, Inc.200690—
+4K243192iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with Plasma Sprayed CPTi…Nextstep Arthopedix, LLC20260—
+4K252451EPORE® XO cup systemImplantcast GmbH20260—
+4K260037implantcast Packaging System UpdateImplantcast GmbH20260—
+4K251833EMPOWR Acetabular® Liner ExtensionEncore Medical L.P.20250—
+4K241875TheRay Collared and Collarless Femoral StemNextstep Arthropedix202411
+4K240834EcoFit® short stem cementless cpTiImplantcast GmbH20241—
+4K233498Stryker Orthopaedics Hip Systems Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics20234—
+4K223103BethaLoc® stem cementless HAImplantcast GmbH20231—
+4K230653Smith & Nephew, Inc. ANTHEM Total Knee System, Genesis Uni Knee System, JOURNEY BCS and…Smith & Nephew, Inc.202331
+4K222632UHR Bipolar Implants, Restoration GAP II ImplantsHowmedica Osteonics Corp., Dba Stryker Orthopaedics20225—
+4K220336Mg-PSZ Ceramic Femoral HeadTheken Companies20220—
+4K210678implaFit® hip stemsImplantcast GmbH20223—
+4K220731Insignia Hip Stem, Restoration Modular 115mm Conical Distal StemStryker20226—
+4K221794Vario-Cup SystemWaldemar Link GmbH & Co. KG20220—
+4K220838Artisan Bone Plug, Universal Cement RestrictorHowmedica Osteonics, Dba Stryker Orthopaedics20225—
+4K220737World Knee Vit-E All-poly Tibial Inserts (CR, PS and UC), World Knee Vit-E Meniscal…Signature Orthopaedics Pty, Ltd.20224—
+4K211221Porous Patella and Porous Tibia BaseplateSmith & Nephew, Inc.20215—
+4K210893Restoration Anatomic ShellHowmedica Osteonics Corp. A.K.A. Stryker Orthopaedics20215—
+4K203420EcoFit® Hip SystemImplantcast GmbH20214—
+4K191708Origin Stem, Evolve Stem, Aria Hip Stem, Remedy Stem, CoCr Femoral HeadSignature Orthopaedics Pty, Ltd.20200—
+4K193429Exeter V40 Femoral Stem, Exeter X3 RimFit CupHowmedica Osteonics Corp.202061
+4K192071iNSitu Total Hip SystemTheken Companies, LLC20194—
+4K191569Implantcast ic-Bipolar Head SystemImplantcast GmbH20193—
+4K191936iNSitu Total Hip SystemThecken Companies, LLC20192—
+4K182468Trident X3 Acetabular Inserts, ADM and MDM X3 Acetabular Inserts, Accolade II Hip SystemHowmedica Osteonics Corp. A.K.A. Stryker Orthopaedics20197—
+4K173499Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral HeadsStryker Orthopaedics201882
+4K173331JOURNEY II XR Knee InstrumentsSmith & Nephew, Inc.201714
+4K172501iNSitu Total Hip SystemTheken Companies, LLC20177—
+4K152439U2 Bipolar Implant and 22mm Femoral HeadUnited Orthopedic Corporation20163—
+4K150007Modified Bencox Hip SystemCorentec Co., Ltd.20157—
+4K150062Excia Total Hip SystemAesculap Implant Systems, LLC20151—
+4K141585Smith & Nephew Disposable Fin PunchSmith & Nephew, Inc.20140—
+4K140915Excia Total Hip SystemAesculap Implant Systems, LLC20142—
+4K131354Renovis Bipolar Hip SystemRenovis Surgical Technologies, LLC20131—
+4K123159Smith & Newphew, Inc. Disposable Knee InstrumentsSmith & Nephew, Inc.20132—
+4K121636Zenith, Femoral Stem Zenith, Distal Centralizer Fomoral Head Acetabular InsertTgm Medical, Inc.20121—
+4K122099Bencox II Stem, Bencox Metal HeadCorentec Co., Ltd.20120—
+4K121684Novation Lpi Prime Femoral StemExactech, Inc.20121—
+4K121665Bencox Foret & Bencox DeltaCorentec Co., Ltd.20128—
+4K120924Bencox Mirabo Cup Bencox Mirabo Insert (Standard& Elevated Tyes) Bencox Mirabo Cup Screw…Corentec Co., Ltd.20128—
+4K112682Metha Hip SystemAesculap Implant Systems, LLC20122—
+4K110542Consensus Biolox Delta Ceramic Femoral HeadConsensus Orthopedics, Inc.20110—
+4K102172Msa Hip SystemGlobal Manufacturing Technology20113—
+4K102424Prevision Hip System with Recon RingAesculap Implant Systems, LLC20100—
+4K090845Apex Arc Hip StemOmni Life Science, Inc.2010582
+4K083312Minihip StemCorin USA201015—
+4K083495Modification to: Metha Hip SystemAesculap Implant Systems, Inc.200959—
+4K081023Evolis Total Knee SystemMedacta International S.A.2008781
+4K082146Metha Short Stem Hip System XL Femoral HeadAesculap Implant Systems, Inc.20082—
+5K261462LANDMARK Total Knee SystemSmith & Nephew, Inc.20260—
+5K261624Omnifit® 20° Series I Insert;Omnifit® Crossfire® 10° Series II Insert; Constrained…Howmedica Osteonics Corp., Dba Stryker Orthopaedics202602
+5K254084AETOS Shoulder System - CONCELOC GlenoidsSmith & Nephew, Inc.20260—
+5K252401implaFit® short stemsImplantcast GmbH20260—
+5K253239Active-V Total Knee System; World Total Knee SystemSignature Orthopaedics Pty, Ltd.20250—
+5K250375Allure Hip Stem and Intramedullary PlugsWaldemar Link GmbH & Co. KG20250—
+5K250989Stryker and Serf hip devicesHowmedica Osteonics Corp (Dba Stryker Orthopaedics)20250—
+5K243456ONVOY™ Acetabular SystemGlobus Medical, Inc.20250—
+5K243784Stryker Orthopaedics Hip Devices Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics20252—
+5K241260ACTIFY™ Unicondylar Knee SystemGlobus Medical, Inc.20240—
+5K242711JOURNEY II Unicompartmental Knee System (JOURNEY II UK)Smith & Nephew, Inc.20240—
+5K240683Rx Knee SystemSignature Orthopaedics Pty, Ltd.20242—