510(k) Report

Devices descending from K001991

188 later devices reach Titan Porocoat Hip Prosthesis through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K170473C2 femoral stemLima Corporate S.P.A.20170—
+3K162942Corin MetaFix Hip StemCorin U.S.A. Limited20173—
+3K161635AMIStem-H Proximal CoatingMedacta International S.A.201710—
+3K162127Bencox M Stem Lateralized & Bencox Mirabo Cup SystemCorentec Co., Ltd.201661
+3K160011H-Max S stemLima Corporate S.P.A.20161—
+3K160907DePuy Actis DuoFix Hip ProsthesisDepuy (Ireland)201626—
+3K153131Logical C-Series Acetabular Shell, Logical Constrained Liner, Logical Constrained Liner…Signature Orthopaedics Pty, Ltd.20164—
+3K152530UCP StemUnited Orthopedic Corporation20162—
+3K150855H-MAX S Femoral Hip SystemLima Corporate S.P.A.20152—
+3K143184Evolve UniPolar HeadSignature Orthopaedics Pty, Ltd.20151—
+3K142201OMNI Interface Acetabular SystemOmnlife Science20151—
+3K141327Minima S SystemLima Corporate S.P.A.20145—
+3K133370Remedy Hip Stem, Pegasus Hip Stem, Evolve Helios Hip Stem, Evolve Masters Hip Stem…Signature Orthopaedics Pty Limited20145—
+3K131952Corin Metafix Hip StemCorin USA20134—
+3K131884Avenir Cemented Hip StemZimmer GmbH20131—
+3K130899Biolox Delta Ceramic Femoral HeadsZimmer GmbH201319—
+3K121439Metafix Femoral Hip Stem Size 1Corin USA20128—
+3K120362Metafix Femoral Stem for Hemi-ArthroplastyCorin USA201261—
+3K103518Trinity Acetabular SystemCorin USA20118—
+4K261576Icona Hip StemCorin, Ltd.20260—
+4K260831Z1 Hip SystemZimmer, Inc.20260—
+4K243192iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with Plasma Sprayed CPTi…Nextstep Arthopedix, LLC20260—
+4K252451EPORE® XO cup systemImplantcast GmbH20260—
+4K250450Coated hip implantsMedacta International S.A.20250—
+4K251906Z1 Hip SystemZimmer, Inc.20251—
+4K243162World LinerSignature Orthopaedics Pty, Ltd.20240—
+4K241636MobileLink Acetabular Cup System - Line Extension (Multiple)Waldemar Link GmbH & Co. KG20242—
+4K241241Z1 Cemented Hip SystemOrchard Medical Development, LLC20240—
+4K240834EcoFit® short stem cementless cpTiImplantcast GmbH20241—
+4K240452Ceramic Femoral HeadMicroport Orthopedics, Inc.20240—
+4K231925MINIMA S SystemLima Corporate S.P.A.20230—
+4K223103BethaLoc® stem cementless HAImplantcast GmbH20231—
+4K231178ACTERA™ hip systemConformis, Inc.20230—
+4K222066LINK MobileLink Acetabular Cup SystemWaldemar Link GmbH & Co. KG20230—
+4K223223BENCOX Mirabo Z Cup CortiniumCorentec Co., Ltd.20230—
+4K220731Insignia Hip Stem, Restoration Modular 115mm Conical Distal StemStryker20226—
+4K210614BENCOX Mirabo Z Cup CortiniumCorentec Co., Ltd.20221—
+4K221059Identity Imprint Knee Replacement System (including Identity Imprint Posterior…Conformis, Inc.20227—
+4K213816MPO Hip InstrumentsMicroport Orthopedics, Inc.20220—
+4K213389Identity Imprint Cruciate Retaining (CR) Knee Replacement System and Identity Imprint…Conformis, Inc.20218—
+4K211866Bencox THR SystemCorentec Co., Ltd.20210—
+4K201047Fusion Taper SystemSignature Orthopaedics Pty, Ltd.20210—
+4K203420EcoFit® Hip SystemImplantcast GmbH20214—
+4K192024Cemented TSI Hip StemSignature Orthopaedics Pty, Ltd.20200—
+4K200112Zimmer Hip Joint ReplacementZimmer GmbH202002
+4K191056Conformity stem, cementedUnited Orthopedic Corporation20200—
+4K192416BIOLOX Delta Ceramic Femoral Heads, BIOLOX Option Ceramic Femoral Head SystemZimmer GmbH20192—
+4K182221Bencox Mirabo Cup Multi HoleCorentec Co., Ltd.20193—
+4K182462Exactech Alteon Highly Polished Femoral StemExactech, Inc.20180—
+4K173794AMIStem-H Proximal Coating, AMIStem-P and AMIStem-P CollaredMedacta International S.A.20189—
+4K172806Bencox Mirabo Cup SystemCorentec Co., Ltd.20174—
+4K163577Ecofit® Hip SystemImplantcast GmbH201791
+4K171156OMNI Anseris Hip StemOmnilife Science20170—
+4K143509MasterSL femoral stemLima Corporate S.P.A.20153—
+4K122185U-Motion II Acetabular SystemUnited Orthopedic Corp.20137—
+4K121563Corin Trifit TS HipCorin USA2012101
+5K261009MobileLink Acetabular Cup System – 40mm ID Inserts (various)Waldemar Link GmbH & Co. KG20260—
+5K243927MobileLink Acetabular Cup System - inhouse coatingsWaldemar Link GmbH & Co. KG20250—
+5K233498Stryker Orthopaedics Hip Systems Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics20234—
+5K223828BENCOX Delta Option HeadsCorentec Co., Ltd.20230—
+5K221149U-Motion II Acetabular System-Extension lineUnited Orthopedic Corporation20231—
+5K221675United U2 femoral head, 22mm delta ceramic headUnited Orthopedic Corporation20220—
+5K221404Identity Imprint Knee Replacement System (including Identity Imprint Posterior…Conformis, Inc.20226—
+5K192126AMIStem-P Short NeckMedacta International S.A.20191—
+5K181254Quadra PMedacta International S.A.20187—
+5K172833E-XPE Acetabular Components and U-Motion II Acetabular CupUnited Orthopedic Corporation20182—
+5K173880Corin TriFit CF Hip StemCorin U.S.A. Limited20183—
+5K170089U-Motion II Acetabular System— Additional sizesUnited Orthopedic Corporation20172—
+5K163441Locking Cage, Full XPE CupUnited Orthopedic Corporation20173—
+5K153772Corin TriFit TS HipCorin U.S.A. Limited20164—
+5K132455U-Motion II PS+ CupUnited Orthopedic Corp.20133—
+5K123619Intrablock Bioball Hip System (Ibs)Merete Medical GmbH20131—
+6K253948Momentum Acetabular Cup SystemUnited Orthopedic Corporation20260—
+6K261624Omnifit® 20° Series I Insert;Omnifit® Crossfire® 10° Series II Insert; Constrained…Howmedica Osteonics Corp., Dba Stryker Orthopaedics202602
+6K243784Stryker Orthopaedics Hip Devices Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics20252—
+6K240418Stryker Orthopaedics Hip Systems Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics20240—
+6K223316Identity Imprint Porous Total Knee Replacement System, Identity Imprint Porous Cruciate…Conformis, Inc.20232—
+6K230846iTotal Identity Knee Replacement System; Identity Imprint Knee Replacement SystemConformis, Inc.20232—
+6K231233Identity™ Imprint™ CR KRS and Identity™ Imprint™ PS KRSConformis, Inc.202301
+6K230844Identity Imprint Cruciate Retaining (CR) Knee Replacement System (KRS) with Cruciate…Conformis, Inc.20231—
+6K202730Quadra-PMedacta International S.A.20201—
+6K192827Quadra-PMedacta International S.A.20206—
+6K141377Bioball Delta Ceramic Heads, Multicup PE Inlay StandardMerete Medical GmbH20140—
+7K243768iTotal® Identity™ Cruciate Retaining 3DP Porous Knee Replacement SystemRestor3D, Inc.20250—
+7K232426Identity Imprint Porous Cruciate Retaining (CR) Knee Replacement System (KRS) with…Conformis, Inc.20230—
+7K220405Amis K LongMedacta International S.A.20220—
+7K210062Mectaplug PE IIMedacta International S.A.20210—
+7K203041SMS Cementless StemMedacta International S.A.20201—