510(k) Report

Devices descending from K082844

165 later devices reach Biolox Delta Ceramic Femoral Head, Biolox Delta Ceramic Femoral Head Offset… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K241483ceramys™ femoral head systemEncore Medical L.P.20251—
+1K191708Origin Stem, Evolve Stem, Aria Hip Stem, Remedy Stem, CoCr Femoral HeadSignature Orthopaedics Pty, Ltd.20200—
+1K100445Klassic HD Hip SystemTotal Joint Orthopedics, Inc.201025—
+1K100412Biolox Delta Ceramic Femoral HeadsSmith & Nephew, Inc.2010140—
+2K251833EMPOWR Acetabular® Liner ExtensionEncore Medical L.P.20250—
+2K220483Platform® Acetabular SystemTotal Joint Orthopedics, Inc.20220—
+2K211176Smith & Nephew Hip SystemsSmith & Nephew, Inc.202231
+2K213580Adapter Sleeve for BIOLOX® OPTION Femoral Head, +10.5mm head lengthTotal Joint Othopedics, Inc.20211—
+2K191399BIOLOX CONTOURA Ceramic Femoral HeadTotal Joint Othopedics, Inc.20190—
+2K180929Klassic HD® Hip SystemTotal Joint Orthopedics, Inc.20185—
+2K171962Klassic HD® Hip SystemTotal Joint Othopedics, Inc.20170—
+2K161073Klassic HD Hip SystemTotal Joint Othopedics, Inc.20166—
+2K151440Klassic HD Hip SystemTotal Joint Orthopedics, Inc.20151—
+2K143113Klassic BiPolar SystemTotal Joint Orthopedics201501
+2K143407Klassic HD Hip SystemTotal Joint Othopedics, Inc.201416—
+2K141972Klassic HD Acetabular Insert with E-Link PolyTotal Joint Orthopedics, Inc.201414—
+2K141327Minima S SystemLima Corporate S.P.A.20145—
+2K133832Klassic HD Hip System, Offset Femoral Stem, Non-Porous / PorousTotal Joint Orthopedics, Inc.20142—
+2K131454Klassic HD (TM) Extended Offset Femoral HeadTotal Joint Orthopedics, Inc.20142—
+2K123598Smith & Nephew, Inc. Hip System InstrumentationSmith & Nephew, Inc.201302
+2K122185U-Motion II Acetabular SystemUnited Orthopedic Corp.20137—
+2K112115Mectacer Biolox (R) Delta Femoral HeadsMedacta International201114—
+2K112463United 36MM Ceramic Femoral Head, DeltaUnited Orthopedic Corporation201181
+2K110087Corin Trinity Acetbular System with Hxlpe LinersCorin USA2011109—
+2K103120Corin Biolox Delta Femoral HeadsCorin USA2011110—
+3K260173M-Vizion Femoral Revision System ExtensionMedacta International S.A.20260—
+3K243809Biolox® Delta Revision headsLimacorporate20250—
+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
+3K231925MINIMA S SystemLima Corporate S.P.A.20230—
+3K221149U-Motion II Acetabular System-Extension lineUnited Orthopedic Corporation20231—
+3K221675United U2 femoral head, 22mm delta ceramic headUnited Orthopedic Corporation20220—
+3K201657Corin Ltd. Hip Products: Trinity™ Acetabular System, Trinity™ PLUS Acetabular Shell…Corin, Ltd.20212—
+3K183532Latitud Hip Replacement SystemMeril Healthcare Pvt., Ltd.20190—
+3K182321MobileLink Acetabular Cup SystemWaldemar Link GmbH & Co. KG20198—
+3K180973Libertas Hip Replacement SystemMaxx Orthopedics, Inc.20183—
+3K180263EcoFit Vit E Acetabular SystemImplantcast GmbH20185—
+3K172857Latitud Hip Replacement SystemMeril Healthcare Pvt., Ltd.20185—
+3K172551Trinity PLUS Acetabular ShellCorin U.S.A. Limited20184—
+3K172833E-XPE Acetabular Components and U-Motion II Acetabular CupUnited Orthopedic Corporation20182—
+3K170359Trinity™ Dual Mobility SystemCorin U.S.A. Limited2017101
+3K173104Klassic HD® Hooded Acetabular Insert with E-Link® Poly, Klassic HD® Low Profile…Total Joint Orthopedics, Inc.20176—
+3K170089U-Motion II Acetabular System— Additional sizesUnited Orthopedic Corporation20172—
+3K163577Ecofit® Hip SystemImplantcast GmbH201791
+3K163441Locking Cage, Full XPE CupUnited Orthopedic Corporation20173—
+3K160895Initia Total Hip System & BIOCERAM AZUL (R) HEADKyocera Medical Corporation20162—
+3K152893Corin Optimized Positioning System (OPS)Corin USA20168—
+3K150855H-MAX S Femoral Hip SystemLima Corporate S.P.A.20152—
+3K150007Modified Bencox Hip SystemCorentec Co., Ltd.20157—
+3K142761Corin TaperFit Hip StemCorin USA201541
+3K143509MasterSL femoral stemLima Corporate S.P.A.20153—
+3K131518Mectacer Biolox Option HeadsMedacta International20130—
+3K122783Plasmafit Acetabular Cup and Vitelene InsertAesculap Implant System, Inc.20130—
+3K131647Trinity Acetabular SystemCorin USA201322—
+3K132455U-Motion II PS+ CupUnited Orthopedic Corp.20133—
+3K130343Corin Trinity Acetabular System with Extra-Long HeadsCorin USA2013332
+3K130128Trinity Acetabular SystemCorin Medical201317—
+3K123705Trinity Non-Occluded Titanium Plasma Sprayed (TPS) Acetabular ShellsCorin USA2013234
+3K122305Corin Trinity-I Acetabular ShellCorin USA201228—
+3K111481Corin Trinity Acetabular System Ecima LinersCorin USA2012331
+3K111911Corin Optimom Modular HeadCorin USA201162—
+4K253948Momentum Acetabular Cup SystemUnited Orthopedic Corporation20260—
+4K261009MobileLink Acetabular Cup System – 40mm ID Inserts (various)Waldemar Link GmbH & Co. KG20260—
+4K252451EPORE® XO cup systemImplantcast GmbH20260—
+4K260037implantcast Packaging System UpdateImplantcast GmbH20260—
+4K253171Libertas Taper Short (TS) Uncemented Femoral Stem (Libertas TS Stem)Maxx Orthopedics, Inc.20260—
+4K242744Trinity EVO Acetabular ShellCorin U.S.A. Limited20250—
+4K242045Initia T3 Acetabular Hemispherical Shell SystemKyocera Medical Technologies, Inc.20250—
+4K243444Bioceram Azul® HeadKyocera Corporation20240—
+4K241636MobileLink Acetabular Cup System - Line Extension (Multiple)Waldemar Link GmbH & Co. KG20242—
+4K241472Icona Hip StemCorin U.S.A. Limited20241—
+4K240834EcoFit® short stem cementless cpTiImplantcast GmbH20241—
+4K223103BethaLoc® stem cementless HAImplantcast GmbH20231—
+4K222436Latitud™ Hip Replacement SystemMeril Healthcare Pvt., Ltd.20230—
+4K222066LINK MobileLink Acetabular Cup SystemWaldemar Link GmbH & Co. KG20230—
+4K210678implaFit® hip stemsImplantcast GmbH20223—
+4K220468BENCOX Mirabo Cup SystemCorentec Co., Ltd.20221—
+4K200607LINK MobileLink® Acetabular Cup System - Dual Mobility Liners, and Shell/Insert AdaptersWaldemar Link GmbH & Co. KG202111
+4K203420EcoFit® Hip SystemImplantcast GmbH20214—
+4K202373APEX 3D Total Ankle Replacement SystemParagon 28, Inc.20200—
+4K192989Libertas E-XLPE Modular LinerMaxx Orthopedics, Inc.20200—
+4K191831MobiliT CupCorin U.S.A. Limited20203—
+4K192559Acetabular Bone Screws (for MobileLink Acetabular Cup System)Waldemar Link GmbH & Co. KG20194—
+4K190890Exactech Alteon Modular Dual Mobility (MDM) SystemExactech, Inc.20190—
+4K190535BiMobile Dual Mobility System - E-Dur InsertsWaldemar Link GmbH & Co. KG201931
+4K190834Corin Optimized Position System Functional Hip Analysis (OPS FHA)Corin USA20195—
+4K181061Corin Optimized Positioning System (OPS) FemoralCorin USA20181—
+4K173583Exactech® Novation® and AcuMatch® E-HXL Acetabular LinersExactech, Inc.201833
+4K170473C2 femoral stemLima Corporate S.P.A.20170—
+4K172806Bencox Mirabo Cup SystemCorentec Co., Ltd.20174—
+4K162127Bencox M Stem Lateralized & Bencox Mirabo Cup SystemCorentec Co., Ltd.201661
+4K160011H-Max S stemLima Corporate S.P.A.20161—
+4K153725Corin TaperFit Hip StemCorin U.S.A. Limited20163—
+4K131952Corin Metafix Hip StemCorin USA20134—
+4K131986Corin Minihip StemCorin USA20133—
+4K123692Pipeline Knee SystemPipeline Orthopedics20130—
+4K120362Metafix Femoral Stem for Hemi-ArthroplastyCorin USA201261—
+5K261576Icona Hip StemCorin, Ltd.20260—
+5K252401implaFit® short stemsImplantcast GmbH20260—