510(k) Report

Devices descending from K001534

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K231873DePuy SUMMIT Porocoat Hip Prosthesis – MR Conditional, DePuy SUMMIT DuoFix Hip…Depuy Ireland UC20245—
+1K153131Logical C-Series Acetabular Shell, Logical Constrained Liner, Logical Constrained Liner…Signature Orthopaedics Pty, Ltd.20164—
+1K140547Excera Fitrite Total Hip Arthroplasty SystemExcera Orthopedics, Inc.20151—
+1K141377Bioball Delta Ceramic Heads, Multicup PE Inlay StandardMerete Medical GmbH20140—
+1K140701Novohip Bipolar Head/Novohip Vitamin E Liner/ Bone Screws/ Hole PlugNovosource, Inc.20142—
+1K123619Intrablock Bioball Hip System (Ibs)Merete Medical GmbH20131—
+1K130128Trinity Acetabular SystemCorin Medical201317—
+1K112898Delta TT Cups, Delta TT Liners, Bone ScrewsLima Corporate S.P.A.201212—
+1K093472Trinity Acetabular SystemCorin USA20101171
+1K100933Consensus CS2 Plus Acetabular InsertConsensus Orthopedics, Inc.201035—
+1K090998Depuy Pinnacle 100 with Gription Acetabular CupsDePuy Orthopaedics, Inc.200948—
+1K071784Depuy Pinnacle with Gripton Acetabular CupsDePuy Orthopaedics, Inc.200772—
+1K040544Duraloc Option Acetabular Cup System, Models 1599-01-044 to -066, 1599-11-044 to -062…Depuy, Inc.2004118—
+1K040383Triflange II Acetabular Cup SystemDePuy Orthopaedics, Inc.20042—
+1K031110Apex Modular Acetabular CupApex Surgical, LLC2003217—
+2K253948Momentum Acetabular Cup SystemUnited Orthopedic Corporation20260—
+2K252824Evolve AP Cup, World Finned Cup, World G-Zero Liner and Oddball Femoral HeadSignature Orthopaedics Pty, Ltd.20260—
+2K251292RECLAIM Monobloc Revision Femoral StemDepuy Ireland UC20251—
+2K243977EMPHASYS Acetabular SystemDepuy Ireland UC20251—
+2K241059Pantheon Proximal Femur Reconstruction (PFR) SystemAdler Ortho S.P.A20250—
+2K242084EMPHASYS Acetabular Shell with RapiTite HADepuy Ireland UC20240—
+2K241690Logical Liner; World Liner; World Knee PatellaSignature Orthopaedics Pty, Ltd.20242—
+2K232556DePuy 3D Additive TriFlange Acetabular Cup and DePuy TriFlange II Acetabular Cup SystemDepuy Ireland UC20230—
+2K231109Xerxes Hip StemXerxes Arthopedix, LLC20230—
+2K221636EMPHASYS Acetabular SystemDepuy Ireland UC20227—
+2K201348DePuy 3D Additive TriFlange Acetabular CupDepuy International, Ltd.20221—
+2K201657Corin Ltd. Hip Products: Trinity™ Acetabular System, Trinity™ PLUS Acetabular Shell…Corin, Ltd.20212—
+2K182321MobileLink Acetabular Cup SystemWaldemar Link GmbH & Co. KG20198—
+2K181491Delta Dual Mobility SystemLima Corporate S.P.A.20190—
+2K182099Delta TT ProLima Corporate S.P.A.20183—
+2K180973Libertas Hip Replacement SystemMaxx Orthopedics, Inc.20183—
+2K172857Latitud Hip Replacement SystemMeril Healthcare Pvt., Ltd.20185—
+2K172551Trinity PLUS Acetabular ShellCorin U.S.A. Limited20184—
+2K171273LINK® BiMobile (TM) Dual Mobility SystemWaldemar Link GmbH & Co. KG201842
+2K172456Bone Screws 6.5mmLima Corporate S.P.A.201812
+2K171156OMNI Anseris Hip StemOmnilife Science20170—
+2K170444PROCOTYL® PRIME Acetabular Cup SystemMicroport Orthopedics, Inc.201716—
+2K151424The Progressive Orthopaedic Total Hip SystemThe Progressive Orthopaedic Company, LLC20161—
+2K153057FitRite™ Total Hip Arthroplasty SystemExcera Orthopedics, Inc.20160—
+2K152893Corin Optimized Positioning System (OPS)Corin USA20168—
+2K150855H-MAX S Femoral Hip SystemLima Corporate S.P.A.20152—
+2K142761Corin TaperFit Hip StemCorin USA201541
+2K141395Delta TT Acetabular SystemLima Corporate S.P.A.2014101
+2K130652Vitalite E Cross-Linked Polyethylene Acetabular InsertConsensus Orthopedics, Inc.20130—
+2K131647Trinity Acetabular SystemCorin USA201322—
+2K130343Corin Trinity Acetabular System with Extra-Long HeadsCorin USA2013332
+2K122185U-Motion II Acetabular SystemUnited Orthopedic Corp.20137—
+2K123705Trinity Non-Occluded Titanium Plasma Sprayed (TPS) Acetabular ShellsCorin USA2013234
+2K121297Origin Hip Stem, Femoral Head, Logical PX-Series Acetabular Shell, Locigal G-Series…Signature Orthopaedics Pty, Ltd.2012202
+2K122305Corin Trinity-I Acetabular ShellCorin USA201228—
+2K122512CS2 Hip SystemConsensus Orthopedics, Inc.20123—
+2K121563Corin Trifit TS HipCorin USA2012101
+2K112779Apex Modular Acctabular Cup (Now Named Apex Interface Acetabular System)Omnlife Science201121
+2K111472Helicon Hip System, Femoral Stem, Helicon Hip System, Femoral Head, Cocr, Helicon Hip…Tgm Medical20114—
+2K110087Corin Trinity Acetbular System with Hxlpe LinersCorin USA2011109—
+2K110542Consensus Biolox Delta Ceramic Femoral HeadConsensus Orthopedics, Inc.20110—
+2K103721Mpact Acetabular SystemMedacta International201121—
+2K103518Trinity Acetabular SystemCorin USA20118—
+2K100445Klassic HD Hip SystemTotal Joint Orthopedics, Inc.201025—
+2K102399Consensus Taperset Hip SystemConsensus Orthopedics, Inc.201033—
+2K101976Interface Acetabular System, Acetabular Insert +4 OffsetOmni Life Science, Inc.201011
+2K093646Depuy Pinnacle with Gription Acetabular CupsDePuy Orthopaedics, Inc.200931—
+2K092443Interface Acetabular Cup LinersOmni Life Science, Inc.20091—
+2K073150Apex-LNK Poly Acetabular Cup LinersOmni Life Science, Inc.200862—
+2K060635Consensus Acetabular Shell SystemHayes Medical, Inc.200669—
+3K260173M-Vizion Femoral Revision System ExtensionMedacta International S.A.20260—
+3K253630Mpact 3D Metal FoamMedacta International S.A.20260—
+3K261009MobileLink Acetabular Cup System – 40mm ID Inserts (various)Waldemar Link GmbH & Co. KG20260—
+3K253171Libertas Taper Short (TS) Uncemented Femoral Stem (Libertas TS Stem)Maxx Orthopedics, Inc.20260—
+3K252067Velora Acetabular SystemRestor3D, Inc.20250—
+3K252846TaperSet™ Hip SystemShalby Advanced Technologies, Inc. Dba Consensus Orthopedics20250—
+3K250450Coated hip implantsMedacta International S.A.20250—
+3K241461Mpact Constrained LinerMedacta International S.A.20251—
+3K242744Trinity EVO Acetabular ShellCorin U.S.A. Limited20250—
+3K243043Origin™ Cemented Hip StemSignature Orthopaedics Pty, Ltd.20250—
+3K243029Origin™ TT StemSignature Orthopaedics Pty, Ltd.20250—
+3K243162World LinerSignature Orthopaedics Pty, Ltd.20240—
+3K241636MobileLink Acetabular Cup System - Line Extension (Multiple)Waldemar Link GmbH & Co. KG20242—
+3K241472Icona Hip StemCorin U.S.A. Limited20241—
+3K240046Ethylene Oxide Sterilization Supplier Change for MPO HipsMicroport Orthopedics20240—
+3K230011Mpact ExtensionMedacta International S.A.20233—
+3K222436Latitud™ Hip Replacement SystemMeril Healthcare Pvt., Ltd.20230—
+3K222066LINK MobileLink Acetabular Cup SystemWaldemar Link GmbH & Co. KG20230—
+3K221149U-Motion II Acetabular System-Extension lineUnited Orthopedic Corporation20231—
+3K221675United U2 femoral head, 22mm delta ceramic headUnited Orthopedic Corporation20220—
+3K220483Platform® Acetabular SystemTotal Joint Orthopedics, Inc.20220—
+3K211567BiMobile Instruments (for BiMobile Dual Mobility System)Waldemar Link GmbH & Co. KG20220—
+3K210614BENCOX Mirabo Z Cup CortiniumCorentec Co., Ltd.20221—
+3K213816MPO Hip InstrumentsMicroport Orthopedics, Inc.20220—
+3K202568Mpact® 3D Metal Implants - DMLS TechnologyMedacta International S.A.20211—
+3K213580Adapter Sleeve for BIOLOX® OPTION Femoral Head, +10.5mm head lengthTotal Joint Othopedics, Inc.20211—
+3K201157Prime BIOFOAM® Multi-Hole ShellsMicroport Orthopedics, Inc.20210—
+3K202705Prime and DYNASTY® Additive Manufacturing ShellsMicroport Orthopedics, Inc.20210—
+3K200607LINK MobileLink® Acetabular Cup System - Dual Mobility Liners, and Shell/Insert AdaptersWaldemar Link GmbH & Co. KG202111
+3K200391MPACT ExtensionMedacta International S.A.20210—
+3K202373APEX 3D Total Ankle Replacement SystemParagon 28, Inc.20200—
+3K192989Libertas E-XLPE Modular LinerMaxx Orthopedics, Inc.20200—
+3K191708Origin Stem, Evolve Stem, Aria Hip Stem, Remedy Stem, CoCr Femoral HeadSignature Orthopaedics Pty, Ltd.20200—
+3K200656Delta Multihole TT Pro Acetabular SystemLima Corporate S.P.A.20200—
+3K191826KeYi Total Hip SystemBeijing Keyi Medical Device Technology Co., Ltd.20200—