510(k) Report

Devices descending from K945115

537 later devices reach Mallory-Head Modular Calcar Repacement Components through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K220468BENCOX Mirabo Cup SystemCorentec Co., Ltd.20221—
+7K221059Identity Imprint Knee Replacement System (including Identity Imprint Posterior…Conformis, Inc.20227—
+7K212512G7® Vivacit-E® Freedom® Constrained LinerZimmer, Inc.20220—
+7K213389Identity Imprint Cruciate Retaining (CR) Knee Replacement System and Identity Imprint…Conformis, Inc.20218—
+7K201047Fusion Taper SystemSignature Orthopaedics Pty, Ltd.20210—
+7K210554Physica systemLima Corporate S.P.A.20212—
+7K201084Physica systemLima Corporate S.P.A.20205—
+7K192683Biolox delta Ceramic Heads, Biolox delta Option Ceramic HeadsBiomet UK, Ltd.20202—
+7K193284Physica LMC Knee SystemLima Corporate S.P.A.20206—
+7K190660G7 Acetabular System Longevity Highly Crosslinked Polyethylene, G7 Acetabular System…Zimmer, Inc.20194—
+7K183457Zimmer Biomet 12/14 CoCr Femoral Head and Freedom HeadZimmer, Inc.20190—
+7K192416BIOLOX Delta Ceramic Femoral Heads, BIOLOX Option Ceramic Femoral Head SystemZimmer GmbH20192—
+7K192071iNSitu Total Hip SystemTheken Companies, LLC20194—
+7K191936iNSitu Total Hip SystemThecken Companies, LLC20192—
+7K190122Renovis A200 PS Knee System as part of the Renovis A200 Knee SystemRenovis Surgical Technologies20191—
+7K190057DJO Acetabular SystemEncore Medical L.P.201925
+7K190068Vanguard XP Knee SystemZimmer, Inc.20190—
+7K182321MobileLink Acetabular Cup SystemWaldemar Link GmbH & Co. KG20198—
+7K182221Bencox Mirabo Cup Multi HoleCorentec Co., Ltd.20193—
+7K183582MPACT ExtensionMedacta International S.A.20194—
+7K181761Zimmer Biomet Select Ceramic HeadsZimmer, Inc.20180—
+7K181947Persona Revision Knee SystemZimmer, Inc.201841
+7K173380b-ONE® Total Hip SystemB-One Ortho, Corp.20180—
+7K180493A3 Total Knee SystemBeijing AK Medical Co., Ltd.20181—
+7K172833E-XPE Acetabular Components and U-Motion II Acetabular CupUnited Orthopedic Corporation20182—
+7K172524Zimmer Persona Personalized Knee SystemZimmer, Inc.201815—
+7K173417Zimmer Persona Personalized Knee SystemZimmer, Inc.20189—
+7K170089U-Motion II Acetabular System— Additional sizesUnited Orthopedic Corporation20172—
+7K163577Ecofit® Hip SystemImplantcast GmbH201791
+7K172501iNSitu Total Hip SystemTheken Companies, LLC20177—
+7K163441Locking Cage, Full XPE CupUnited Orthopedic Corporation20173—
+7K171156OMNI Anseris Hip StemOmnilife Science20170—
+7K171054Biomet Knee Joint Replacement ProsthesesBiomet, Inc.201754
+7K171962Klassic HD® Hip SystemTotal Joint Othopedics, Inc.20170—
+7K161592Persona Partial Knee SystemBiomet, Inc.201652
+7K160738ZUK Select Knee SystemSmith & Nephew, Inc.20168—
+7K161366ConfoMIS iTotal Cruciate Retaining (CR) Knee Replacement System (iTotal CR KRS)Conformis, Inc.201618—
+7K153657Vanguard XP Knee SystemBiomet, Inc.201611
+7K152008Physica PS Knee SystemLima Corporate S.P.A.20157—
+7K151266Physica CR Knee SystemLima Corporate S.P.A.20158—
+7K151440Klassic HD Hip SystemTotal Joint Orthopedics, Inc.20151—
+7K150090Zimmer Persona Personalized Knee SystemZimmer, Inc.201517—
+7K143242Rebel 3DKNEE SystemEncore Medical L.P.20151117
+7K150007Modified Bencox Hip SystemCorentec Co., Ltd.20157—
+7K143635KINETIS Total Knee SystemMako Surgical20150—
+7K142882G7 Freedom and Offset Liners, Freedom Head, Size 32Biomet, Inc.201517—
+7K143113Klassic BiPolar SystemTotal Joint Orthopedics201501
+7K142746G7 Finned Acetabular ShellBiomet Manufactuting Corp.20140—
+7K143407Klassic HD Hip SystemTotal Joint Othopedics, Inc.201416—
+7K140669G7 Osseoti Acetublar ShellsBiomet, Inc.201435—
+7K141407Vanguard XP Femoral Component (Gen II)/Vanguard XP Femoral TrialBiomet, Inc.201421
+7K141635Arthrex Ibalance Tka SystemArthrex, Inc.201415—
+7K140701Novohip Bipolar Head/Novohip Vitamin E Liner/ Bone Screws/ Hole PlugNovosource, Inc.20142—
+7K140257Signature Planner, Signature GuidesMaterialise NV20140—
+7K133560Itotal Cruciate Retaining Knee Replacment SystemConformis, Inc.20140—
+7K133832Klassic HD Hip System, Offset Femoral Stem, Non-Porous / PorousTotal Joint Orthopedics, Inc.20142—
+7K131454Klassic HD (TM) Extended Offset Femoral HeadTotal Joint Orthopedics, Inc.20142—
+7K132873Vanguard XP Knee SystemBiomet, Inc.2013322
+7K131337Balanced Knee System High Flex Vitamin E PS Tibial Insert and PatellaOrtho Development Corp.20133—
+7K130365X-Alt Highly Cross Linked VE Acetabular LinerEncore Medical L.P.201338—
+7K132455U-Motion II PS+ CupUnited Orthopedic Corp.20133—
+7K131467Itotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc.201330—
+7K123598Smith & Nephew, Inc. Hip System InstrumentationSmith & Nephew, Inc.201302
+7K131019Itotal Cruciate Retaining (C) Knee Replacement SystemConformis, Inc.201330—
+7K123692Pipeline Knee SystemPipeline Orthopedics20130—
+7K130899Biolox Delta Ceramic Femoral HeadsZimmer GmbH201319—
+7K123459Zimmer Persona TM Personalized Knee SystemZimmer, Inc.2013910
+7K123982Turon Glenoid Pegged, E+, Turon Keeled Glenoid, E+Encore Medical L.P.201335—
+7K121727Movation Knee SystemEncore Medical L.P.201214—
+7K113756Highly Cross Linked VE Central Peg Patella Highly Cross Linked VE Tri-Peg Patella Highly…Encore Medical L.P.2012351
+7K112115Mectacer Biolox (R) Delta Femoral HeadsMedacta International201114—
+7K110087Corin Trinity Acetbular System with Hxlpe LinersCorin USA2011109—
+7K103120Corin Biolox Delta Femoral HeadsCorin USA2011110—
+7K103223Highly Cross-Linked Vitamin E Uhmwpe Tibial InsertsEncore Medical L.P.201037—
+7K090299Biolox Option Ceramic Femoral Head and Metha XL HeadsAesculap Implant Systems20091—
+7K083762Biolox Delta Ceramic Femoral HeadsSmith & Nephew, Inc.2009149—
+7K082991Biolox Delta Ceramic Femoral HeadAesculap Implant Systems, Inc.200863—
+8K261453G7® Acetabular SystemZimmer Biomet20260—
+8K262057GMK ExtensionMedacta International SA20260—
+8K261462LANDMARK Total Knee SystemSmith & Nephew, Inc.20260—
+8K261009MobileLink Acetabular Cup System – 40mm ID Inserts (various)Waldemar Link GmbH & Co. KG20260—
+8K251840Zimmer® Persona® Personalized Knee SystemZimmer, Inc.20260—
+8K252824Evolve AP Cup, World Finned Cup, World G-Zero Liner and Oddball Femoral HeadSignature Orthopaedics Pty, Ltd.20260—
+8K253189Persona the Personalized Knee System (Persona Porous Plasma Spray PPS Femurs)Zimmer, Inc.20260—
+8K252623G7® Revision Acetabular SystemZimmer, Inc.20260—
+8K253239Active-V Total Knee System; World Total Knee SystemSignature Orthopaedics Pty, Ltd.20250—
+8K251834Persona Partial KneeZimmer Biomet20250—
+8K250980Physica System (Physica CR Porous Femoral components)Lima Corporate S.P.A.20250—
+8K243724Persona® Revision Knee System (Persona Revision SoluTion™ Femoral Components)Zimmer, Inc.20250—
+8K243574Evolution® Total Knee Systems - Kinematic Alignment Instrumentation and TechniqueMicroport Orthopedics, Inc.20251—
+8K243293Zimmer® Persona® Personalized Knee SystemZimmer Biomet20241—
+8K243615Physica Porous Femoral ComponentsLima Corporate S.P.A.20241—
+8K241260ACTIFY™ Unicondylar Knee SystemGlobus Medical, Inc.20240—
+8K242543Persona the Personalized Knee System (Persona Ti-Nidium PPS Femurs)Zimmer, Inc.20240—
+8K241636MobileLink Acetabular Cup System - Line Extension (Multiple)Waldemar Link GmbH & Co. KG20242—
+8K242412Agility Symmetric™ Total Knee SystemMedisurge, LLC20240—
+8K242711JOURNEY II Unicompartmental Knee System (JOURNEY II UK)Smith & Nephew, Inc.20240—
+8K240783Anthology Hip Stems; CPCS Hip Stems; Femoral Heads; R3 Acetabular Liners; Spectron Hip…Smith & Nephew, Inc.20240—
+8K242375OR3O Dual Mobility SystemSmith & Nephew, Inc.20240—
+8K241570Unity Total Knee SystemCorin U.S.A. Limited20240—