510(k) Report

Devices descending from K931189

405 later devices reach P.F.C. Total Hip System Porous Coated Modular Acet through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K983014Summit Acetabular SystemJohnson & Johnson Professionals, Inc.1998404—
+2K231873DePuy SUMMIT Porocoat Hip Prosthesis – MR Conditional, DePuy SUMMIT DuoFix Hip…Depuy Ireland UC20245—
+2K000306Pinnacle Acetabular SystemDePuy Orthopaedics, Inc.20004031
+3K251292RECLAIM Monobloc Revision Femoral StemDepuy Ireland UC20251—
+3K243977EMPHASYS Acetabular SystemDepuy Ireland UC20251—
+3K242084EMPHASYS Acetabular Shell with RapiTite HADepuy Ireland UC20240—
+3K210614BENCOX Mirabo Z Cup CortiniumCorentec Co., Ltd.20221—
+3K192919Pinnacle Duofix HA Acetabular Cup ProsthesisDePuy Orthopaedics, Inc.20196—
+3K172857Latitud Hip Replacement SystemMeril Healthcare Pvt., Ltd.20185—
+3K172806Bencox Mirabo Cup SystemCorentec Co., Ltd.20174—
+3K162125MALUC™ Total Hip Arthroplasty SystemSurgtech, Inc.20170—
+3K162127Bencox M Stem Lateralized & Bencox Mirabo Cup SystemCorentec Co., Ltd.201661
+3K160895Initia Total Hip System & BIOCERAM AZUL (R) HEADKyocera Medical Corporation20162—
+3K153131Logical C-Series Acetabular Shell, Logical Constrained Liner, Logical Constrained Liner…Signature Orthopaedics Pty, Ltd.20164—
+3K141377Bioball Delta Ceramic Heads, Multicup PE Inlay StandardMerete Medical GmbH20140—
+3K123619Intrablock Bioball Hip System (Ibs)Merete Medical GmbH20131—
+3K121297Origin Hip Stem, Femoral Head, Logical PX-Series Acetabular Shell, Locigal G-Series…Signature Orthopaedics Pty, Ltd.2012202
+3K120924Bencox Mirabo Cup Bencox Mirabo Insert (Standard& Elevated Tyes) Bencox Mirabo Cup Screw…Corentec Co., Ltd.20128—
+3K103384Escalade Acetabular Cup SystemOrtho Development201131
+3K073413Depuy Asr 300 Acetabular Cup SystemDePuy Orthopaedics, Inc.2008136
+3K062148Depuy Pinnacle Altrx Acetabular Cup LinerDePuy Orthopaedics, Inc.2006106—
+3K031495Pinnacle Duofix HA Acetabular Cup ProsthesisDePuy Orthopaedics, Inc.2003207—
+3K031110Apex Modular Acetabular CupApex Surgical, LLC2003217—
+3K001534Pinnacle Acetabular SystemDePuy Orthopaedics, Inc.2000267—
+4K260173M-Vizion Femoral Revision System ExtensionMedacta International S.A.20260—
+4K252824Evolve AP Cup, World Finned Cup, World G-Zero Liner and Oddball Femoral HeadSignature Orthopaedics Pty, Ltd.20260—
+4K252067Velora Acetabular SystemRestor3D, Inc.20250—
+4K243043Origin™ Cemented Hip StemSignature Orthopaedics Pty, Ltd.20250—
+4K242045Initia T3 Acetabular Hemispherical Shell SystemKyocera Medical Technologies, Inc.20250—
+4K243029Origin™ TT StemSignature Orthopaedics Pty, Ltd.20250—
+4K243444Bioceram Azul® HeadKyocera Corporation20240—
+4K241636MobileLink Acetabular Cup System - Line Extension (Multiple)Waldemar Link GmbH & Co. KG20242—
+4K241690Logical Liner; World Liner; World Knee PatellaSignature Orthopaedics Pty, Ltd.20242—
+4K231109Xerxes Hip StemXerxes Arthopedix, LLC20230—
+4K222436Latitud™ Hip Replacement SystemMeril Healthcare Pvt., Ltd.20230—
+4K223223BENCOX Mirabo Z Cup CortiniumCorentec Co., Ltd.20230—
+4K220468BENCOX Mirabo Cup SystemCorentec Co., Ltd.20221—
+4K211866Bencox THR SystemCorentec Co., Ltd.20210—
+4K191708Origin Stem, Evolve Stem, Aria Hip Stem, Remedy Stem, CoCr Femoral HeadSignature Orthopaedics Pty, Ltd.20200—
+4K192559Acetabular Bone Screws (for MobileLink Acetabular Cup System)Waldemar Link GmbH & Co. KG20194—
+4K190704Signature Ceramic Femoral HeadSignature Orthopaedics Pty, Ltd.20192—
+4K183532Latitud Hip Replacement SystemMeril Healthcare Pvt., Ltd.20190—
+4K182221Bencox Mirabo Cup Multi HoleCorentec Co., Ltd.20193—
+4K180973Libertas Hip Replacement SystemMaxx Orthopedics, Inc.20183—
+4K171156OMNI Anseris Hip StemOmnilife Science20170—
+4K161155Origin Coxa Vara Hip StemSignature Orthopaedics Pty, Ltd.201611
+4K161080Escalade Legend Acetabular ShellOrtho Development Corporation20161—
+4K150007Modified Bencox Hip SystemCorentec Co., Ltd.20157—
+4K143184Evolve UniPolar HeadSignature Orthopaedics Pty, Ltd.20151—
+4K140547Excera Fitrite Total Hip Arthroplasty SystemExcera Orthopedics, Inc.20151—
+4K133370Remedy Hip Stem, Pegasus Hip Stem, Evolve Helios Hip Stem, Evolve Masters Hip Stem…Signature Orthopaedics Pty Limited20145—
+4K140701Novohip Bipolar Head/Novohip Vitamin E Liner/ Bone Screws/ Hole PlugNovosource, Inc.20142—
+4K130128Trinity Acetabular SystemCorin Medical201317—
+4K112898Delta TT Cups, Delta TT Liners, Bone ScrewsLima Corporate S.P.A.201212—
+4K121777U2 Acetabular Cup, Plasma SprayUnited Orthopedic Corp.201291
+4K112779Apex Modular Acctabular Cup (Now Named Apex Interface Acetabular System)Omnlife Science201121
+4K102370R3 Xlpe Anteverted LinersSmith & Nephew, Inc.20116—
+4K100445Klassic HD Hip SystemTotal Joint Orthopedics, Inc.201025—
+4K093472Trinity Acetabular SystemCorin USA20101171
+4K100933Consensus CS2 Plus Acetabular InsertConsensus Orthopedics, Inc.201035—
+4K101976Interface Acetabular System, Acetabular Insert +4 OffsetOmni Life Science, Inc.201011
+4K093363Cocr and Oxinium Femoral Heads and R3 Xlpe LinersSmith & Nephew, Inc.201016—
+4K092443Interface Acetabular Cup LinersOmni Life Science, Inc.20091—
+4K090998Depuy Pinnacle 100 with Gription Acetabular CupsDePuy Orthopaedics, Inc.200948—
+4K080991Depuy Asr XL Modular Acetabular Cup SystemDePuy Orthopaedics, Inc.2008041
+4K073150Apex-LNK Poly Acetabular Cup LinersOmni Life Science, Inc.200862—
+4K072963Depuy Pinnacle Altrx Acetabular LinersDePuy Orthopaedics, Inc.200819—
+4K071784Depuy Pinnacle with Gripton Acetabular CupsDePuy Orthopaedics, Inc.200772—
+4K060635Consensus Acetabular Shell SystemHayes Medical, Inc.200669—
+4K042344Excia Total Hip SystemAesculap, Inc.200519810
+4K040544Duraloc Option Acetabular Cup System, Models 1599-01-044 to -066, 1599-11-044 to -062…Depuy, Inc.2004118—
+4K040383Triflange II Acetabular Cup SystemDePuy Orthopaedics, Inc.20042—
+5K253948Momentum Acetabular Cup SystemUnited Orthopedic Corporation20260—
+5K261009MobileLink Acetabular Cup System – 40mm ID Inserts (various)Waldemar Link GmbH & Co. KG20260—
+5K253171Libertas Taper Short (TS) Uncemented Femoral Stem (Libertas TS Stem)Maxx Orthopedics, Inc.20260—
+5K243927MobileLink Acetabular Cup System - inhouse coatingsWaldemar Link GmbH & Co. KG20250—
+5K241059Pantheon Proximal Femur Reconstruction (PFR) SystemAdler Ortho S.P.A20250—
+5K243162World LinerSignature Orthopaedics Pty, Ltd.20240—
+5K242833Legend® Acetabular ShellOrtho Development Corp.20240—
+5K240452Ceramic Femoral HeadMicroport Orthopedics, Inc.20240—
+5K232556DePuy 3D Additive TriFlange Acetabular Cup and DePuy TriFlange II Acetabular Cup SystemDepuy Ireland UC20230—
+5K222066LINK MobileLink Acetabular Cup SystemWaldemar Link GmbH & Co. KG20230—
+5K220483Platform® Acetabular SystemTotal Joint Orthopedics, Inc.20220—
+5K221636EMPHASYS Acetabular SystemDepuy Ireland UC20227—
+5K211176Smith & Nephew Hip SystemsSmith & Nephew, Inc.202231
+5K201348DePuy 3D Additive TriFlange Acetabular CupDepuy International, Ltd.20221—
+5K211330R3 Large Head LinersSmith & Nephew, Inc.20220—
+5K213580Adapter Sleeve for BIOLOX® OPTION Femoral Head, +10.5mm head lengthTotal Joint Othopedics, Inc.20211—
+5K201657Corin Ltd. Hip Products: Trinity™ Acetabular System, Trinity™ PLUS Acetabular Shell…Corin, Ltd.20212—
+5K201047Fusion Taper SystemSignature Orthopaedics Pty, Ltd.20210—
+5K192989Libertas E-XLPE Modular LinerMaxx Orthopedics, Inc.20200—
+5K192024Cemented TSI Hip StemSignature Orthopaedics Pty, Ltd.20200—
+5K191399BIOLOX CONTOURA Ceramic Femoral HeadTotal Joint Othopedics, Inc.20190—
+5K182321MobileLink Acetabular Cup SystemWaldemar Link GmbH & Co. KG20198—
+5K181491Delta Dual Mobility SystemLima Corporate S.P.A.20190—
+5K183582MPACT ExtensionMedacta International S.A.20194—
+5K182099Delta TT ProLima Corporate S.P.A.20183—
+5K182535R3 Anteverted LinersSmith & Nephew, Inc.20184—
+5K180263EcoFit Vit E Acetabular SystemImplantcast GmbH20185—
+5K172551Trinity PLUS Acetabular ShellCorin U.S.A. Limited20184—