510(k) Report

Devices descending from K033338

73 later devices reach Pinnacle Revision System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K231873DePuy SUMMIT Porocoat Hip Prosthesis – MR Conditional, DePuy SUMMIT DuoFix Hip…Depuy Ireland UC20245—
+1K132879Mpact ExtensionMedacta International201411—
+1K122641Mpact ExtensionMedacta International201214—
+1K071784Depuy Pinnacle with Gripton Acetabular CupsDePuy Orthopaedics, Inc.200772—
+2K253630Mpact 3D Metal FoamMedacta International S.A.20260—
+2K250450Coated hip implantsMedacta International S.A.20250—
+2K251292RECLAIM Monobloc Revision Femoral StemDepuy Ireland UC20251—
+2K243977EMPHASYS Acetabular SystemDepuy Ireland UC20251—
+2K242084EMPHASYS Acetabular Shell with RapiTite HADepuy Ireland UC20240—
+2K230011Mpact ExtensionMedacta International S.A.20233—
+2K221636EMPHASYS Acetabular SystemDepuy Ireland UC20227—
+2K202568Mpact® 3D Metal Implants - DMLS TechnologyMedacta International S.A.20211—
+2K200391MPACT ExtensionMedacta International S.A.20210—
+2K183582MPACT ExtensionMedacta International S.A.20194—
+2K171966Mpact® 3D Metal™ Implants and Augments 3D Metal™Medacta International S.A.20183—
+2K143453Mpact Double Mobility SystemMedacta International20151—
+2K140547Excera Fitrite Total Hip Arthroplasty SystemExcera Orthopedics, Inc.20151—
+2K131458Mpact DM Liner ConverterMedacta International20133—
+2K121297Origin Hip Stem, Femoral Head, Logical PX-Series Acetabular Shell, Locigal G-Series…Signature Orthopaedics Pty, Ltd.2012202
+2K103721Mpact Acetabular SystemMedacta International201121—
+2K093646Depuy Pinnacle with Gription Acetabular CupsDePuy Orthopaedics, Inc.200931—
+2K090998Depuy Pinnacle 100 with Gription Acetabular CupsDePuy Orthopaedics, Inc.200948—
+3K260173M-Vizion Femoral Revision System ExtensionMedacta International S.A.20260—
+3K253948Momentum Acetabular Cup SystemUnited Orthopedic Corporation20260—
+3K252824Evolve AP Cup, World Finned Cup, World G-Zero Liner and Oddball Femoral HeadSignature Orthopaedics Pty, Ltd.20260—
+3K251043Mpact 3D Metal Implants Extension – DMLS TechnologyMedacta International S.A.20260—
+3K252067Velora Acetabular SystemRestor3D, Inc.20250—
+3K241461Mpact Constrained LinerMedacta International S.A.20251—
+3K243043Origin™ Cemented Hip StemSignature Orthopaedics Pty, Ltd.20250—
+3K242232Mpact 3D Metal Augments IIMedacta International S.A.20250—
+3K243029Origin™ TT StemSignature Orthopaedics Pty, Ltd.20250—
+3K241767Versacem Acetabular Shell and Double Mobility HC LinersMedacta International S.A.20250—
+3K241690Logical Liner; World Liner; World Knee PatellaSignature Orthopaedics Pty, Ltd.20242—
+3K231109Xerxes Hip StemXerxes Arthopedix, LLC20230—
+3K211891DM Converter - TiN coatedMedacta International S.A.20220—
+3K210614BENCOX Mirabo Z Cup CortiniumCorentec Co., Ltd.20221—
+3K191708Origin Stem, Evolve Stem, Aria Hip Stem, Remedy Stem, CoCr Femoral HeadSignature Orthopaedics Pty, Ltd.20200—
+3K192559Acetabular Bone Screws (for MobileLink Acetabular Cup System)Waldemar Link GmbH & Co. KG20194—
+3K190704Signature Ceramic Femoral HeadSignature Orthopaedics Pty, Ltd.20192—
+3K170444PROCOTYL® PRIME Acetabular Cup SystemMicroport Orthopedics, Inc.201716—
+3K161155Origin Coxa Vara Hip StemSignature Orthopaedics Pty, Ltd.201611
+3K153057FitRite™ Total Hip Arthroplasty SystemExcera Orthopedics, Inc.20160—
+3K153131Logical C-Series Acetabular Shell, Logical Constrained Liner, Logical Constrained Liner…Signature Orthopaedics Pty, Ltd.20164—
+3K143184Evolve UniPolar HeadSignature Orthopaedics Pty, Ltd.20151—
+3K133370Remedy Hip Stem, Pegasus Hip Stem, Evolve Helios Hip Stem, Evolve Masters Hip Stem…Signature Orthopaedics Pty Limited20145—
+3K122783Plasmafit Acetabular Cup and Vitelene InsertAesculap Implant System, Inc.20130—
+3K122911Versafitcup CC Trio ExtensionMedacta International20121—
+3K120531Versafitcup CC Trio-Additional LinersMedacta International20122—
+3K111145Endo HeadMedacta International20110—
+4K243162World LinerSignature Orthopaedics Pty, Ltd.20240—
+4K241636MobileLink Acetabular Cup System - Line Extension (Multiple)Waldemar Link GmbH & Co. KG20242—
+4K240046Ethylene Oxide Sterilization Supplier Change for MPO HipsMicroport Orthopedics20240—
+4K240452Ceramic Femoral HeadMicroport Orthopedics, Inc.20240—
+4K222066LINK MobileLink Acetabular Cup SystemWaldemar Link GmbH & Co. KG20230—
+4K223223BENCOX Mirabo Z Cup CortiniumCorentec Co., Ltd.20230—
+4K213816MPO Hip InstrumentsMicroport Orthopedics, Inc.20220—
+4K201157Prime BIOFOAM® Multi-Hole ShellsMicroport Orthopedics, Inc.20210—
+4K202705Prime and DYNASTY® Additive Manufacturing ShellsMicroport Orthopedics, Inc.20210—
+4K201047Fusion Taper SystemSignature Orthopaedics Pty, Ltd.20210—
+4K192024Cemented TSI Hip StemSignature Orthopaedics Pty, Ltd.20200—
+4K190123MicroPort CoCr Femoral HeadsMicroport Orthopedics, Inc.20191—
+4K173898MicroPort Orthopedics Total Hip Systems MR LabelingMicroport Orthopedics Inc. (Mpo)20181—
+4K180798Prime Acetabular Cup SystemMicroport Orthopedics, Inc.20182—
+4K171181PROCOTYL® PRIME E-CLASS™ XLPE LinerMicroport Orthopedics, Inc.201710—
+5K261009MobileLink Acetabular Cup System – 40mm ID Inserts (various)Waldemar Link GmbH & Co. KG20260—
+5K243927MobileLink Acetabular Cup System - inhouse coatingsWaldemar Link GmbH & Co. KG20250—
+5K181598Prime E-CLASS XLPE LinerMicroport Orthopedics, Inc.20181—
+5K180263EcoFit Vit E Acetabular SystemImplantcast GmbH20185—
+6K252451EPORE® XO cup systemImplantcast GmbH20260—
+6K260037implantcast Packaging System UpdateImplantcast GmbH20260—
+6K240834EcoFit® short stem cementless cpTiImplantcast GmbH20241—
+6K223103BethaLoc® stem cementless HAImplantcast GmbH20231—
+6K203420EcoFit® Hip SystemImplantcast GmbH20214—