510(k) Report

Devices descending from K921274

644 later devices reach Metallic Toatal Hip System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K181761Zimmer Biomet Select Ceramic HeadsZimmer, Inc.20180—
+6K182462Exactech Alteon Highly Polished Femoral StemExactech, Inc.20180—
+6K181947Persona Revision Knee SystemZimmer, Inc.201841
+6K173960DePuy Corail AMT Hip ProsthesisDepuy France S.A.S.201814—
+6K173380b-ONE® Total Hip SystemB-One Ortho, Corp.20180—
+6K180493A3 Total Knee SystemBeijing AK Medical Co., Ltd.20181—
+6K172833E-XPE Acetabular Components and U-Motion II Acetabular CupUnited Orthopedic Corporation20182—
+6K172524Zimmer Persona Personalized Knee SystemZimmer, Inc.201815—
+6K180929Klassic HD® Hip SystemTotal Joint Orthopedics, Inc.20185—
+6K170339Summit Hip SystemDePuy Orthopaedics, Inc.201827—
+6K173794AMIStem-H Proximal Coating, AMIStem-P and AMIStem-P CollaredMedacta International S.A.20189—
+6K173417Zimmer Persona Personalized Knee SystemZimmer, Inc.20189—
+6K172467OMNI ARC Anteverted Neck Hip StemOmnilife Science20170—
+6K170089U-Motion II Acetabular System— Additional sizesUnited Orthopedic Corporation20172—
+6K163441Locking Cage, Full XPE CupUnited Orthopedic Corporation20173—
+6K171249Entrada™ hip stemOrtho Development Corporation20172—
+6K171054Biomet Knee Joint Replacement ProsthesesBiomet, Inc.201754
+6K171962Klassic HD® Hip SystemTotal Joint Othopedics, Inc.20170—
+6K161840LINK® SP-CL® Hip System PoroLink® (microporous) and HX® (CaP) coated & LINK® LCU® Hip…Waldemar Link GmbH & Co. KG20171—
+6K161592Persona Partial Knee SystemBiomet, Inc.201652
+6K161073Klassic HD Hip SystemTotal Joint Othopedics, Inc.20166—
+6K160738ZUK Select Knee SystemSmith & Nephew, Inc.20168—
+6K161366ConfoMIS iTotal Cruciate Retaining (CR) Knee Replacement System (iTotal CR KRS)Conformis, Inc.201618—
+6K153657Vanguard XP Knee SystemBiomet, Inc.201611
+6K152008Physica PS Knee SystemLima Corporate S.P.A.20157—
+6K151266Physica CR Knee SystemLima Corporate S.P.A.20158—
+6K150862DePuy Actis Duofox Hip ProsthesisDePuy Orthopaedics, Inc.2015381
+6K151293Aequalis Ascend Flex Shoulder System, Aequalis Reversed Shoulder ProsthesisTornier S.A.S.201520—
+6K150576TGM Biolox delta Ceramic HeadsTgm Medical, Inc.20150—
+6K151440Klassic HD Hip SystemTotal Joint Orthopedics, Inc.20151—
+6K150090Zimmer Persona Personalized Knee SystemZimmer, Inc.201517—
+6K143242Rebel 3DKNEE SystemEncore Medical L.P.20151117
+6K150007Modified Bencox Hip SystemCorentec Co., Ltd.20157—
+6K150503Echo Bi-Metric Microplasty Line ExtensionBiomet, Inc.20150—
+6K143635KINETIS Total Knee SystemMako Surgical20150—
+6K142882G7 Freedom and Offset Liners, Freedom Head, Size 32Biomet, Inc.201517—
+6K143113Klassic BiPolar SystemTotal Joint Orthopedics201501
+6K142746G7 Finned Acetabular ShellBiomet Manufactuting Corp.20140—
+6K143407Klassic HD Hip SystemTotal Joint Othopedics, Inc.201416—
+6K140669G7 Osseoti Acetublar ShellsBiomet, Inc.201435—
+6K141407Vanguard XP Femoral Component (Gen II)/Vanguard XP Femoral TrialBiomet, Inc.201421
+6K141972Klassic HD Acetabular Insert with E-Link PolyTotal Joint Orthopedics, Inc.201414—
+6K141635Arthrex Ibalance Tka SystemArthrex, Inc.201415—
+6K141821Alteon Neck Preserving Femoral Stem, Standard Offset, Size 6-7; Alteon Neck Preserving…Exactech, Inc.201401
+6K140701Novohip Bipolar Head/Novohip Vitamin E Liner/ Bone Screws/ Hole PlugNovosource, Inc.20142—
+6K140257Signature Planner, Signature GuidesMaterialise NV20140—
+6K133560Itotal Cruciate Retaining Knee Replacment SystemConformis, Inc.20140—
+6K133832Klassic HD Hip System, Offset Femoral Stem, Non-Porous / PorousTotal Joint Orthopedics, Inc.20142—
+6K131454Klassic HD (TM) Extended Offset Femoral HeadTotal Joint Orthopedics, Inc.20142—
+6K132873Vanguard XP Knee SystemBiomet, Inc.2013322
+6K131337Balanced Knee System High Flex Vitamin E PS Tibial Insert and PatellaOrtho Development Corp.20133—
+6K130365X-Alt Highly Cross Linked VE Acetabular LinerEncore Medical L.P.201338—
+6K132455U-Motion II PS+ CupUnited Orthopedic Corp.20133—
+6K122883Exp Tibial Inserts and Patellar Components for the Proven Gen-Flex Total Knee SystemStelkast Company201341
+6K131467Itotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc.201330—
+6K123598Smith & Nephew, Inc. Hip System InstrumentationSmith & Nephew, Inc.201302
+6K131019Itotal Cruciate Retaining (C) Knee Replacement SystemConformis, Inc.201330—
+6K123692Pipeline Knee SystemPipeline Orthopedics20130—
+6K123459Zimmer Persona TM Personalized Knee SystemZimmer, Inc.2013910
+6K123982Turon Glenoid Pegged, E+, Turon Keeled Glenoid, E+Encore Medical L.P.201335—
+6K122158PBP Total Hip SystemPipeline Biomedical Products, LLC201221—
+6K121727Movation Knee SystemEncore Medical L.P.201214—
+6K113756Highly Cross Linked VE Central Peg Patella Highly Cross Linked VE Tri-Peg Patella Highly…Encore Medical L.P.2012351
+6K112115Mectacer Biolox (R) Delta Femoral HeadsMedacta International201114—
+6K110087Corin Trinity Acetbular System with Hxlpe LinersCorin USA2011109—
+6K103120Corin Biolox Delta Femoral HeadsCorin USA2011110—
+6K103223Highly Cross-Linked Vitamin E Uhmwpe Tibial InsertsEncore Medical L.P.201037—
+6K083762Biolox Delta Ceramic Femoral HeadsSmith & Nephew, Inc.2009149—
+6K082991Biolox Delta Ceramic Femoral HeadAesculap Implant Systems, Inc.200863—
+7K261453G7® Acetabular SystemZimmer Biomet20260—
+7K262057GMK ExtensionMedacta International SA20260—
+7K261462LANDMARK Total Knee SystemSmith & Nephew, Inc.20260—
+7K254043TRIVANCE™ Hip StemGlobus Medical, Inc.20260—
+7K262251ACTIFY™ Total Knee System, ACTIFY™ 3D Total Knee System (ACTIFY MC Tibial Insert)Globus Medical, Inc.20260—
+7K261009MobileLink Acetabular Cup System – 40mm ID Inserts (various)Waldemar Link GmbH & Co. KG20260—
+7K260831Z1 Hip SystemZimmer, Inc.20260—
+7K251840Zimmer® Persona® Personalized Knee SystemZimmer, Inc.20260—
+7K253992Veritas Reverse Total Shoulder SystemRestor3D20260—
+7K254128InSet Reverse Total Shoulder SystemShoulder Innovations, Inc.20260—
+7K252824Evolve AP Cup, World Finned Cup, World G-Zero Liner and Oddball Femoral HeadSignature Orthopaedics Pty, Ltd.20260—
+7K253624INHANCE™ Reverse Shoulder SystemDepuy Ireland UC20260—
+7K253189Persona the Personalized Knee System (Persona Porous Plasma Spray PPS Femurs)Zimmer, Inc.20260—
+7K252623G7® Revision Acetabular SystemZimmer, Inc.20260—
+7K250644MSS - Monobloc stemMedacta International S.A.202611
+7K253239Active-V Total Knee System; World Total Knee SystemSignature Orthopaedics Pty, Ltd.20250—
+7K250375Allure Hip Stem and Intramedullary PlugsWaldemar Link GmbH & Co. KG20250—
+7K252411JARVIS Glenoid Reverse Shoulder ProsthesisFH Industrie20250—
+7K251834Persona Partial KneeZimmer Biomet20250—
+7K250989Stryker and Serf hip devicesHowmedica Osteonics Corp (Dba Stryker Orthopaedics)20250—
+7K251906Z1 Hip SystemZimmer, Inc.20251—
+7K251166Mfinity Femoral SystemMedacta International S.A.20250—
+7K251052Trivicta® Hip StemOrtho Development Corp.20250—
+7K250980Physica System (Physica CR Porous Femoral components)Lima Corporate S.P.A.20250—
+7K250444NEXUS® Hip StemMicroport Orthopedics, Inc.20250—
+7K243029Origin™ TT StemSignature Orthopaedics Pty, Ltd.20250—
+7K243724Persona® Revision Knee System (Persona Revision SoluTion™ Femoral Components)Zimmer, Inc.20250—
+7K243574Evolution® Total Knee Systems - Kinematic Alignment Instrumentation and TechniqueMicroport Orthopedics, Inc.20251—
+7K241817InSet Total Shoulder SystemShoulder Innovations, Inc.20251—
+7K243293Zimmer® Persona® Personalized Knee SystemZimmer Biomet20241—
+7K243615Physica Porous Femoral ComponentsLima Corporate S.P.A.20241—