510(k) Report

Devices descending from K945518

212 later devices reach P.F.C. 2 Total Hip System Porous Coated Modular Femoral Component through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K231109Xerxes Hip StemXerxes Arthopedix, LLC20230—
+5K222436Latitud™ Hip Replacement SystemMeril Healthcare Pvt., Ltd.20230—
+5K221462DePuy Reclaim Monobloc Revision Femoral StemDepuy Ireland UC20226—
+5K221104Actera™ hip systemConformis, Inc.202211
+5K220468BENCOX Mirabo Cup SystemCorentec Co., Ltd.20221—
+5K212069Corin MetaFix™ Hip StemCorin U.S.A. Limited20222—
+5K211703Insignia Hip StemStryker Orthopaedics20217—
+5K201657Corin Ltd. Hip Products: Trinity™ Acetabular System, Trinity™ PLUS Acetabular Shell…Corin, Ltd.20212—
+5K201519PROFEMUR® GLADIATOR® Cemented Classic StemMicroport Orthopedics, Inc.20201—
+5K192989Libertas E-XLPE Modular LinerMaxx Orthopedics, Inc.20200—
+5K202484Cordera Hip SystemConformis, Inc.202022
+5K191708Origin Stem, Evolve Stem, Aria Hip Stem, Remedy Stem, CoCr Femoral HeadSignature Orthopaedics Pty, Ltd.20200—
+5K200007PROFEMUR GLADIATOR Thin HA Classic Hip Stem with CollarMicroport Orthopedics, Inc.20201—
+5K192559Acetabular Bone Screws (for MobileLink Acetabular Cup System)Waldemar Link GmbH & Co. KG20194—
+5K192189Avenir Complete Hip System, Size 0 Coxa VaraZimmer, Inc.20194—
+5K193030Avenir Muller Stem, Avenir Cemented Hip StemZimmer GmbH20193—
+5K192198Conformis Hip SystemConformis, Inc.2019121
+5K190704Signature Ceramic Femoral HeadSignature Orthopaedics Pty, Ltd.20192—
+5K183532Latitud Hip Replacement SystemMeril Healthcare Pvt., Ltd.20190—
+5K173898MicroPort Orthopedics Total Hip Systems MR LabelingMicroport Orthopedics Inc. (Mpo)20181—
+5K180263EcoFit Vit E Acetabular SystemImplantcast GmbH20185—
+5K170473C2 femoral stemLima Corporate S.P.A.20170—
+5K162942Corin MetaFix Hip StemCorin U.S.A. Limited20173—
+5K161635AMIStem-H Proximal CoatingMedacta International S.A.201710—
+5K162127Bencox M Stem Lateralized & Bencox Mirabo Cup SystemCorentec Co., Ltd.201661
+5K160011H-Max S stemLima Corporate S.P.A.20161—
+5K160907DePuy Actis DuoFix Hip ProsthesisDepuy (Ireland)201626—
+5K153131Logical C-Series Acetabular Shell, Logical Constrained Liner, Logical Constrained Liner…Signature Orthopaedics Pty, Ltd.20164—
+5K152530UCP StemUnited Orthopedic Corporation20162—
+5K150855H-MAX S Femoral Hip SystemLima Corporate S.P.A.20152—
+5K151902REDAPT¿ Revision Femoral SystemSmith & Nephew, Inc.20157—
+5K143184Evolve UniPolar HeadSignature Orthopaedics Pty, Ltd.20151—
+5K142201OMNI Interface Acetabular SystemOmnlife Science20151—
+5K141327Minima S SystemLima Corporate S.P.A.20145—
+5K133370Remedy Hip Stem, Pegasus Hip Stem, Evolve Helios Hip Stem, Evolve Masters Hip Stem…Signature Orthopaedics Pty Limited20145—
+5K131952Corin Metafix Hip StemCorin USA20134—
+5K132435Smith & Nephew Global Femoral Head TrialsSmith & Nephew, Inc.20130—
+5K131884Avenir Cemented Hip StemZimmer GmbH20131—
+5K130899Biolox Delta Ceramic Femoral HeadsZimmer GmbH201319—
+5K121439Metafix Femoral Hip Stem Size 1Corin USA20128—
+5K120362Metafix Femoral Stem for Hemi-ArthroplastyCorin USA201261—
+5K103518Trinity Acetabular SystemCorin USA20118—
+6K261576Icona Hip StemCorin, Ltd.20260—
+6K260831Z1 Hip SystemZimmer, Inc.20260—
+6K243192iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with Plasma Sprayed CPTi…Nextstep Arthopedix, LLC20260—
+6K252451EPORE® XO cup systemImplantcast GmbH20260—
+6K250450Coated hip implantsMedacta International S.A.20250—
+6K243021Longboard Revision Hip StemSignature Orthopaedics Pty, Ltd.20250—
+6K251906Z1 Hip SystemZimmer, Inc.20251—
+6K243162World LinerSignature Orthopaedics Pty, Ltd.20240—
+6K241636MobileLink Acetabular Cup System - Line Extension (Multiple)Waldemar Link GmbH & Co. KG20242—
+6K241241Z1 Cemented Hip SystemOrchard Medical Development, LLC20240—
+6K240834EcoFit® short stem cementless cpTiImplantcast GmbH20241—
+6K240452Ceramic Femoral HeadMicroport Orthopedics, Inc.20240—
+6K231925MINIMA S SystemLima Corporate S.P.A.20230—
+6K223103BethaLoc® stem cementless HAImplantcast GmbH20231—
+6K231178ACTERA™ hip systemConformis, Inc.20230—
+6K222066LINK MobileLink Acetabular Cup SystemWaldemar Link GmbH & Co. KG20230—
+6K223223BENCOX Mirabo Z Cup CortiniumCorentec Co., Ltd.20230—
+6K220731Insignia Hip Stem, Restoration Modular 115mm Conical Distal StemStryker20226—
+6K210614BENCOX Mirabo Z Cup CortiniumCorentec Co., Ltd.20221—
+6K221059Identity Imprint Knee Replacement System (including Identity Imprint Posterior…Conformis, Inc.20227—
+6K213816MPO Hip InstrumentsMicroport Orthopedics, Inc.20220—
+6K213389Identity Imprint Cruciate Retaining (CR) Knee Replacement System and Identity Imprint…Conformis, Inc.20218—
+6K211866Bencox THR SystemCorentec Co., Ltd.20210—
+6K201047Fusion Taper SystemSignature Orthopaedics Pty, Ltd.20210—
+6K203420EcoFit® Hip SystemImplantcast GmbH20214—
+6K192024Cemented TSI Hip StemSignature Orthopaedics Pty, Ltd.20200—
+6K200112Zimmer Hip Joint ReplacementZimmer GmbH202002
+6K191056Conformity stem, cementedUnited Orthopedic Corporation20200—
+6K192416BIOLOX Delta Ceramic Femoral Heads, BIOLOX Option Ceramic Femoral Head SystemZimmer GmbH20192—
+6K182221Bencox Mirabo Cup Multi HoleCorentec Co., Ltd.20193—
+6K182462Exactech Alteon Highly Polished Femoral StemExactech, Inc.20180—
+6K173794AMIStem-H Proximal Coating, AMIStem-P and AMIStem-P CollaredMedacta International S.A.20189—
+6K172806Bencox Mirabo Cup SystemCorentec Co., Ltd.20174—
+6K163577Ecofit® Hip SystemImplantcast GmbH201791
+6K171156OMNI Anseris Hip StemOmnilife Science20170—
+6K143509MasterSL femoral stemLima Corporate S.P.A.20153—
+6K122185U-Motion II Acetabular SystemUnited Orthopedic Corp.20137—
+6K121563Corin Trifit TS HipCorin USA2012101
+7K261009MobileLink Acetabular Cup System – 40mm ID Inserts (various)Waldemar Link GmbH & Co. KG20260—
+7K243927MobileLink Acetabular Cup System - inhouse coatingsWaldemar Link GmbH & Co. KG20250—
+7K233498Stryker Orthopaedics Hip Systems Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics20234—
+7K223828BENCOX Delta Option HeadsCorentec Co., Ltd.20230—
+7K221149U-Motion II Acetabular System-Extension lineUnited Orthopedic Corporation20231—
+7K221675United U2 femoral head, 22mm delta ceramic headUnited Orthopedic Corporation20220—
+7K221404Identity Imprint Knee Replacement System (including Identity Imprint Posterior…Conformis, Inc.20226—
+7K192126AMIStem-P Short NeckMedacta International S.A.20191—
+7K181254Quadra PMedacta International S.A.20187—
+7K172833E-XPE Acetabular Components and U-Motion II Acetabular CupUnited Orthopedic Corporation20182—
+7K173880Corin TriFit CF Hip StemCorin U.S.A. Limited20183—
+7K170089U-Motion II Acetabular System— Additional sizesUnited Orthopedic Corporation20172—
+7K163441Locking Cage, Full XPE CupUnited Orthopedic Corporation20173—
+7K153772Corin TriFit TS HipCorin U.S.A. Limited20164—
+7K132455U-Motion II PS+ CupUnited Orthopedic Corp.20133—
+7K123619Intrablock Bioball Hip System (Ibs)Merete Medical GmbH20131—
+8K253948Momentum Acetabular Cup SystemUnited Orthopedic Corporation20260—
+8K261624Omnifit® 20° Series I Insert;Omnifit® Crossfire® 10° Series II Insert; Constrained…Howmedica Osteonics Corp., Dba Stryker Orthopaedics202602
+8K243784Stryker Orthopaedics Hip Devices Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics20252—
+8K240418Stryker Orthopaedics Hip Systems Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics20240—