510(k) Report

Devices descending from K920640

493 later devices reach Full Hemisphere Ring-Loc Liner through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K120038A200 Knee SystemRenovis Surgical Technologies, LLC20132—
+5K122870Itotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc.201333—
+5K122529Zimmer Unicompartmental Knee System Vivacit-E Articular SurfaceZimmer, Inc.201215—
+5K121771Zimmer Persona the Personalized Knee SystemZimmer, Inc.2012592
+5K120370Vivacit-E Vitamin E Highly Crosslinked Polyethylene LinersZimmer, Inc.201288—
+5K113550Vanguard Complete Knee SystemBiomet Manufacturing Corp2012467
+5K100445Klassic HD Hip SystemTotal Joint Orthopedics, Inc.201025—
+5K091956Highly Cross-Linked Vitamin E Uhmwpe Tibial Inserts, Model 391/392-09_19-702_712Encore Medical L.P.20101194
+5K100412Biolox Delta Ceramic Femoral HeadsSmith & Nephew, Inc.2010140—
+5K071535Biolox Delta Ceramic Femoral HeadZimmer, Inc.20072173
+6K253961SK Knee SystemJust Medical Devices (Tianjin) Co., Ltd.20260—
+6K261009MobileLink Acetabular Cup System – 40mm ID Inserts (various)Waldemar Link GmbH & Co. KG20260—
+6K252451EPORE® XO cup systemImplantcast GmbH20260—
+6K260037implantcast Packaging System UpdateImplantcast GmbH20260—
+6K252824Evolve AP Cup, World Finned Cup, World G-Zero Liner and Oddball Femoral HeadSignature Orthopaedics Pty, Ltd.20260—
+6K252623G7® Revision Acetabular SystemZimmer, Inc.20260—
+6K252067Velora Acetabular SystemRestor3D, Inc.20250—
+6K251833EMPOWR Acetabular® Liner ExtensionEncore Medical L.P.20250—
+6K242744Trinity EVO Acetabular ShellCorin U.S.A. Limited20250—
+6K250834Zimmer Biomet Ceramic Heads (22.2mm diameter)Zimmer Biomet20250—
+6K243295Initia Knee SystemKyocera Medical Technologies, Inc.20250—
+6K241636MobileLink Acetabular Cup System - Line Extension (Multiple)Waldemar Link GmbH & Co. KG20242—
+6K240834EcoFit® short stem cementless cpTiImplantcast GmbH20241—
+6K240046Ethylene Oxide Sterilization Supplier Change for MPO HipsMicroport Orthopedics20240—
+6K240452Ceramic Femoral HeadMicroport Orthopedics, Inc.20240—
+6K230011Mpact ExtensionMedacta International S.A.20233—
+6K223103BethaLoc® stem cementless HAImplantcast GmbH20231—
+6K231178ACTERA™ hip systemConformis, Inc.20230—
+6K230653Smith & Nephew, Inc. ANTHEM Total Knee System, Genesis Uni Knee System, JOURNEY BCS and…Smith & Nephew, Inc.202331
+6K222066LINK MobileLink Acetabular Cup SystemWaldemar Link GmbH & Co. KG20230—
+6K223548GMK Sphere & GMK SpheriKA CementlessMedacta International S.A.20231—
+6K221149U-Motion II Acetabular System-Extension lineUnited Orthopedic Corporation20231—
+6K221479Persona Personalized Knee SystemZimmer, Inc.20228—
+6K222566Zimmer Persona Personalized Knee SystemZimmer, Inc.20222—
+6K222380TriVerse Total Knee Replacement SystemSignature Orthopaedics Pty, Ltd.20221—
+6K221104Actera™ hip systemConformis, Inc.202211
+6K211176Smith & Nephew Hip SystemsSmith & Nephew, Inc.202231
+6K210614BENCOX Mirabo Z Cup CortiniumCorentec Co., Ltd.20221—
+6K220468BENCOX Mirabo Cup SystemCorentec Co., Ltd.20221—
+6K221059Identity Imprint Knee Replacement System (including Identity Imprint Posterior…Conformis, Inc.20227—
+6K213580Adapter Sleeve for BIOLOX® OPTION Femoral Head, +10.5mm head lengthTotal Joint Othopedics, Inc.20211—
+6K213389Identity Imprint Cruciate Retaining (CR) Knee Replacement System and Identity Imprint…Conformis, Inc.20218—
+6K201657Corin Ltd. Hip Products: Trinity™ Acetabular System, Trinity™ PLUS Acetabular Shell…Corin, Ltd.20212—
+6K201047Fusion Taper SystemSignature Orthopaedics Pty, Ltd.20210—
+6K210554Physica systemLima Corporate S.P.A.20212—
+6K203472KMTI Hip Replacement SystemKyocera Medical Technologies, Inc.20210—
+6K203420EcoFit® Hip SystemImplantcast GmbH20214—
+6K201084Physica systemLima Corporate S.P.A.20205—
+6K201660KMTI Hip Replacement System, Tesera Trabecular Technologies (T3) Acetabular Shell…Kyocera Medical Technologies, Inc.20200—
+6K200823Zimmer, Inc. Hip Joint Prostheses MR Labeling IZimmer, Inc.202011
+6K200328Tesera Trabecular Technologies (T3) Acetabular Shell System, Porous Acetabular Cup SystemKyocera Medical Technologies, Inc.20201—
+6K192683Biolox delta Ceramic Heads, Biolox delta Option Ceramic HeadsBiomet UK, Ltd.20202—
+6K193284Physica LMC Knee SystemLima Corporate S.P.A.20206—
+6K191831MobiliT CupCorin U.S.A. Limited20203—
+6K192559Acetabular Bone Screws (for MobileLink Acetabular Cup System)Waldemar Link GmbH & Co. KG20194—
+6K190660G7 Acetabular System Longevity Highly Crosslinked Polyethylene, G7 Acetabular System…Zimmer, Inc.20194—
+6K190890Exactech Alteon Modular Dual Mobility (MDM) SystemExactech, Inc.20190—
+6K192416BIOLOX Delta Ceramic Femoral Heads, BIOLOX Option Ceramic Femoral Head SystemZimmer GmbH20192—
+6K191399BIOLOX CONTOURA Ceramic Femoral HeadTotal Joint Othopedics, Inc.20190—
+6K190535BiMobile Dual Mobility System - E-Dur InsertsWaldemar Link GmbH & Co. KG201931
+6K190122Renovis A200 PS Knee System as part of the Renovis A200 Knee SystemRenovis Surgical Technologies20191—
+6K190068Vanguard XP Knee SystemZimmer, Inc.20190—
+6K181761Zimmer Biomet Select Ceramic HeadsZimmer, Inc.20180—
+6K181947Persona Revision Knee SystemZimmer, Inc.201841
+6K180493A3 Total Knee SystemBeijing AK Medical Co., Ltd.20181—
+6K172551Trinity PLUS Acetabular ShellCorin U.S.A. Limited20184—
+6K172833E-XPE Acetabular Components and U-Motion II Acetabular CupUnited Orthopedic Corporation20182—
+6K172524Zimmer Persona Personalized Knee SystemZimmer, Inc.201815—
+6K173417Zimmer Persona Personalized Knee SystemZimmer, Inc.20189—
+6K170089U-Motion II Acetabular System— Additional sizesUnited Orthopedic Corporation20172—
+6K163577Ecofit® Hip SystemImplantcast GmbH201791
+6K163441Locking Cage, Full XPE CupUnited Orthopedic Corporation20173—
+6K171054Biomet Knee Joint Replacement ProsthesesBiomet, Inc.201754
+6K171962Klassic HD® Hip SystemTotal Joint Othopedics, Inc.20170—
+6K161592Persona Partial Knee SystemBiomet, Inc.201652
+6K161184iNSitu Total Hip SystemTheken Companies, LLC201619—
+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—
+6K150576TGM Biolox delta Ceramic HeadsTgm Medical, Inc.20150—
+6K151440Klassic HD Hip SystemTotal Joint Orthopedics, Inc.20151—
+6K142814Biomet Orthopaedic Salvage System (OSSTM) - Proximal Femoral & Hybrid TibialBiomet Manufacturing, LLC201516
+6K150090Zimmer Persona Personalized Knee SystemZimmer, Inc.201517—
+6K143242Rebel 3DKNEE SystemEncore Medical L.P.20151117
+6K150007Modified Bencox Hip SystemCorentec Co., Ltd.20157—
+6K143635KINETIS Total Knee SystemMako Surgical20150—
+6K143113Klassic BiPolar SystemTotal Joint Orthopedics201501
+6K143407Klassic HD Hip SystemTotal Joint Othopedics, Inc.201416—
+6K141407Vanguard XP Femoral Component (Gen II)/Vanguard XP Femoral TrialBiomet, Inc.201421
+6K141635Arthrex Ibalance Tka SystemArthrex, Inc.201415—
+6K141327Minima S SystemLima Corporate S.P.A.20145—
+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—