510(k) Report

Devices descending from K001534

267 later devices reach Pinnacle Acetabular System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K192559Acetabular Bone Screws (for MobileLink Acetabular Cup System)Waldemar Link GmbH & Co. KG20194—
+3K192450Precision Casting Solutions Total Hip SystemPrecision Casting Solution, LLC20190—
+3K191622Delta Multihole TT Pro Acetabular SystemLima Corporate S.P.A.20192—
+3K191399BIOLOX CONTOURA Ceramic Femoral HeadTotal Joint Othopedics, Inc.20190—
+3K190704Signature Ceramic Femoral HeadSignature Orthopaedics Pty, Ltd.20192—
+3K190535BiMobile Dual Mobility System - E-Dur InsertsWaldemar Link GmbH & Co. KG201931
+3K190834Corin Optimized Position System Functional Hip Analysis (OPS FHA)Corin USA20195—
+3K183532Latitud Hip Replacement SystemMeril Healthcare Pvt., Ltd.20190—
+3K190123MicroPort CoCr Femoral HeadsMicroport Orthopedics, Inc.20191—
+3K183582MPACT ExtensionMedacta International S.A.20194—
+3K183042SMR Lateralized Connectors with screwsLima Corporate S.P.A.20190—
+3K173898MicroPort Orthopedics Total Hip Systems MR LabelingMicroport Orthopedics Inc. (Mpo)20181—
+3K181061Corin Optimized Positioning System (OPS) FemoralCorin USA20181—
+3K180798Prime Acetabular Cup SystemMicroport Orthopedics, Inc.20182—
+3K172833E-XPE Acetabular Components and U-Motion II Acetabular CupUnited Orthopedic Corporation20182—
+3K180929Klassic HD® Hip SystemTotal Joint Orthopedics, Inc.20185—
+3K173880Corin TriFit CF Hip StemCorin U.S.A. Limited20183—
+3K171966Mpact® 3D Metal™ Implants and Augments 3D Metal™Medacta International S.A.20183—
+3K170473C2 femoral stemLima Corporate S.P.A.20170—
+3K170359Trinity™ Dual Mobility SystemCorin U.S.A. Limited2017101
+3K170089U-Motion II Acetabular System— Additional sizesUnited Orthopedic Corporation20172—
+3K171181PROCOTYL® PRIME E-CLASS™ XLPE LinerMicroport Orthopedics, Inc.201710—
+3K163441Locking Cage, Full XPE CupUnited Orthopedic Corporation20173—
+3K171962Klassic HD® Hip SystemTotal Joint Othopedics, Inc.20170—
+3K161073Klassic HD Hip SystemTotal Joint Othopedics, Inc.20166—
+3K160011H-Max S stemLima Corporate S.P.A.20161—
+3K161155Origin Coxa Vara Hip StemSignature Orthopaedics Pty, Ltd.201611
+3K153772Corin TriFit TS HipCorin U.S.A. Limited20164—
+3K153725Corin TaperFit Hip StemCorin U.S.A. Limited20163—
+3K153381Corin Metafix Hip StemCorin U.S.A. Limited201651
+3K150576TGM Biolox delta Ceramic HeadsTgm Medical, Inc.20150—
+3K151440Klassic HD Hip SystemTotal Joint Orthopedics, Inc.20151—
+3K143184Evolve UniPolar HeadSignature Orthopaedics Pty, Ltd.20151—
+3K143453Mpact Double Mobility SystemMedacta International20151—
+3K143113Klassic BiPolar SystemTotal Joint Orthopedics201501
+3K142201OMNI Interface Acetabular SystemOmnlife Science20151—
+3K143407Klassic HD Hip SystemTotal Joint Othopedics, Inc.201416—
+3K141972Klassic HD Acetabular Insert with E-Link PolyTotal Joint Orthopedics, Inc.201414—
+3K133370Remedy Hip Stem, Pegasus Hip Stem, Evolve Helios Hip Stem, Evolve Masters Hip Stem…Signature Orthopaedics Pty Limited20145—
+3K141043CS2 Multi-Hole Acetabular ShellConsensus Orthopedics, Inc.201421—
+3K133832Klassic HD Hip System, Offset Femoral Stem, Non-Porous / PorousTotal Joint Orthopedics, Inc.20142—
+3K131454Klassic HD (TM) Extended Offset Femoral HeadTotal Joint Orthopedics, Inc.20142—
+3K132879Mpact ExtensionMedacta International201411—
+3K131952Corin Metafix Hip StemCorin USA20134—
+3K131986Corin Minihip StemCorin USA20133—
+3K122783Plasmafit Acetabular Cup and Vitelene InsertAesculap Implant System, Inc.20130—
+3K131458Mpact DM Liner ConverterMedacta International20133—
+3K132455U-Motion II PS+ CupUnited Orthopedic Corp.20133—
+3K123782Paragon Hip SystemGlobal Manufacturing Technology20132—
+3K121509Treasure Bipolar Head, Femoral Head, Treasure Bipolar Head, InsertTgm Medical, Inc.20120—
+3K121636Zenith, Femoral Stem Zenith, Distal Centralizer Fomoral Head Acetabular InsertTgm Medical, Inc.20121—
+3K122911Versafitcup CC Trio ExtensionMedacta International20121—
+3K122641Mpact ExtensionMedacta International201214—
+3K121935Taperset Hip Small StemsConsensus Orthopedics, Inc.201220—
+3K121263Taper Set Hip System RDP StemConsensus Orthopedics, Inc.20120—
+3K120531Versafitcup CC Trio-Additional LinersMedacta International20122—
+3K112802Pipeline Total Hip SystemPipeline Orthopedics201253—
+3K111481Corin Trinity Acetabular System Ecima LinersCorin USA2012331
+3K111145Endo HeadMedacta International20110—
+3K111911Corin Optimom Modular HeadCorin USA201162—
+3K101575Apex Modular Head, Size 28 ,32, 26 and 40 MM+10.5 Offset, Models 302810…Omnlife Science201024—
+3K101451Apex Module Hip System Biolox Delta Femoral HeadOmni Life Science, Inc.20104—
+3K100555Apex-LNK Acetabular Insert, E, Apex-LNK Acetabular Insert, F, Apex-LNKOmni Life Science, Inc.2010341
+4K261576Icona Hip StemCorin, Ltd.20260—
+4K251043Mpact 3D Metal Implants Extension – DMLS TechnologyMedacta International S.A.20260—
+4K251833EMPOWR Acetabular® Liner ExtensionEncore Medical L.P.20250—
+4K243927MobileLink Acetabular Cup System - inhouse coatingsWaldemar Link GmbH & Co. KG20250—
+4K242232Mpact 3D Metal Augments IIMedacta International S.A.20250—
+4K241767Versacem Acetabular Shell and Double Mobility HC LinersMedacta International S.A.20250—
+4K243809Biolox® Delta Revision headsLimacorporate20250—
+4K240452Ceramic Femoral HeadMicroport Orthopedics, Inc.20240—
+4K223223BENCOX Mirabo Z Cup CortiniumCorentec Co., Ltd.20230—
+4K211891DM Converter - TiN coatedMedacta International S.A.20220—
+4K212069Corin MetaFix™ Hip StemCorin U.S.A. Limited20222—
+4K201047Fusion Taper SystemSignature Orthopaedics Pty, Ltd.20210—
+4K193545Corin Optimized Positioning System (OPS) FemoralCorin USA20200—
+4K193042Optimized Positioning System (OPS) ReViewCorin USA20200—
+4K192024Cemented TSI Hip StemSignature Orthopaedics Pty, Ltd.20200—
+4K192656Optimized Positioning System (OPS) InsightCorin USA20203—
+4K191831MobiliT CupCorin U.S.A. Limited20203—
+4K190890Exactech Alteon Modular Dual Mobility (MDM) SystemExactech, Inc.20190—
+4K181598Prime E-CLASS XLPE LinerMicroport Orthopedics, Inc.20181—
+4K180263EcoFit Vit E Acetabular SystemImplantcast GmbH20185—
+4K173583Exactech® Novation® and AcuMatch® E-HXL Acetabular LinersExactech, Inc.201833
+4K173104Klassic HD® Hooded Acetabular Insert with E-Link® Poly, Klassic HD® Low Profile…Total Joint Orthopedics, Inc.20176—
+4K163577Ecofit® Hip SystemImplantcast GmbH201791
+4K162942Corin MetaFix Hip StemCorin U.S.A. Limited20173—
+4K162719iTotal® Hip Replacement SystemConformis, Inc.2017174
+4K161184iNSitu Total Hip SystemTheken Companies, LLC201619—
+4K152919OMNI Skirted HeadsOmni Life Science, Inc.20161—
+4K142606Trident® Tritanium® PST® Acetabular ShellsMako Surgical Corp.20150—
+4K142675CI../..X liner for NOVAE Dual Mobility Acetabular CupSerf20153—
+4K130353Pipeline Total Hip System (Line Extension)Pipeline Orthopedics20131—
+4K123692Pipeline Knee SystemPipeline Orthopedics20130—
+4K122158PBP Total Hip SystemPipeline Biomedical Products, LLC201221—
+4K120362Metafix Femoral Stem for Hemi-ArthroplastyCorin USA201261—
+5K243192iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with Plasma Sprayed CPTi…Nextstep Arthopedix, LLC20260—
+5K252451EPORE® XO cup systemImplantcast GmbH20260—
+5K260037implantcast Packaging System UpdateImplantcast GmbH20260—
+5K241875TheRay Collared and Collarless Femoral StemNextstep Arthropedix202411