510(k) Report

Devices descending from K974331

189 later devices reach Uni-Rom Total Hip System Femoral Stem through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K180263EcoFit Vit E Acetabular SystemImplantcast GmbH20185—
+4K170473C2 femoral stemLima Corporate S.P.A.20170—
+4K162942Corin MetaFix Hip StemCorin U.S.A. Limited20173—
+4K161635AMIStem-H Proximal CoatingMedacta International S.A.201710—
+4K162127Bencox M Stem Lateralized & Bencox Mirabo Cup SystemCorentec Co., Ltd.201661
+4K160011H-Max S stemLima Corporate S.P.A.20161—
+4K160907DePuy Actis DuoFix Hip ProsthesisDepuy (Ireland)201626—
+4K153131Logical C-Series Acetabular Shell, Logical Constrained Liner, Logical Constrained Liner…Signature Orthopaedics Pty, Ltd.20164—
+4K152530UCP StemUnited Orthopedic Corporation20162—
+4K150855H-MAX S Femoral Hip SystemLima Corporate S.P.A.20152—
+4K143184Evolve UniPolar HeadSignature Orthopaedics Pty, Ltd.20151—
+4K142201OMNI Interface Acetabular SystemOmnlife Science20151—
+4K141327Minima S SystemLima Corporate S.P.A.20145—
+4K133370Remedy Hip Stem, Pegasus Hip Stem, Evolve Helios Hip Stem, Evolve Masters Hip Stem…Signature Orthopaedics Pty Limited20145—
+4K131952Corin Metafix Hip StemCorin USA20134—
+4K131884Avenir Cemented Hip StemZimmer GmbH20131—
+4K130899Biolox Delta Ceramic Femoral HeadsZimmer GmbH201319—
+4K121439Metafix Femoral Hip Stem Size 1Corin USA20128—
+4K120362Metafix Femoral Stem for Hemi-ArthroplastyCorin USA201261—
+4K103518Trinity Acetabular SystemCorin USA20118—
+5K261576Icona Hip StemCorin, Ltd.20260—
+5K260831Z1 Hip SystemZimmer, Inc.20260—
+5K243192iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with Plasma Sprayed CPTi…Nextstep Arthopedix, LLC20260—
+5K252451EPORE® XO cup systemImplantcast GmbH20260—
+5K250450Coated hip implantsMedacta International S.A.20250—
+5K251906Z1 Hip SystemZimmer, Inc.20251—
+5K243162World LinerSignature Orthopaedics Pty, Ltd.20240—
+5K241636MobileLink Acetabular Cup System - Line Extension (Multiple)Waldemar Link GmbH & Co. KG20242—
+5K241241Z1 Cemented Hip SystemOrchard Medical Development, LLC20240—
+5K240834EcoFit® short stem cementless cpTiImplantcast GmbH20241—
+5K240452Ceramic Femoral HeadMicroport Orthopedics, Inc.20240—
+5K231925MINIMA S SystemLima Corporate S.P.A.20230—
+5K223103BethaLoc® stem cementless HAImplantcast GmbH20231—
+5K231178ACTERA™ hip systemConformis, Inc.20230—
+5K222066LINK MobileLink Acetabular Cup SystemWaldemar Link GmbH & Co. KG20230—
+5K223223BENCOX Mirabo Z Cup CortiniumCorentec Co., Ltd.20230—
+5K220731Insignia Hip Stem, Restoration Modular 115mm Conical Distal StemStryker20226—
+5K210614BENCOX Mirabo Z Cup CortiniumCorentec Co., Ltd.20221—
+5K221059Identity Imprint Knee Replacement System (including Identity Imprint Posterior…Conformis, Inc.20227—
+5K213816MPO Hip InstrumentsMicroport Orthopedics, Inc.20220—
+5K213389Identity Imprint Cruciate Retaining (CR) Knee Replacement System and Identity Imprint…Conformis, Inc.20218—
+5K211866Bencox THR SystemCorentec Co., Ltd.20210—
+5K201047Fusion Taper SystemSignature Orthopaedics Pty, Ltd.20210—
+5K203420EcoFit® Hip SystemImplantcast GmbH20214—
+5K192024Cemented TSI Hip StemSignature Orthopaedics Pty, Ltd.20200—
+5K200112Zimmer Hip Joint ReplacementZimmer GmbH202002
+5K191056Conformity stem, cementedUnited Orthopedic Corporation20200—
+5K192416BIOLOX Delta Ceramic Femoral Heads, BIOLOX Option Ceramic Femoral Head SystemZimmer GmbH20192—
+5K182221Bencox Mirabo Cup Multi HoleCorentec Co., Ltd.20193—
+5K182462Exactech Alteon Highly Polished Femoral StemExactech, Inc.20180—
+5K173794AMIStem-H Proximal Coating, AMIStem-P and AMIStem-P CollaredMedacta International S.A.20189—
+5K172806Bencox Mirabo Cup SystemCorentec Co., Ltd.20174—
+5K163577Ecofit® Hip SystemImplantcast GmbH201791
+5K171156OMNI Anseris Hip StemOmnilife Science20170—
+5K143509MasterSL femoral stemLima Corporate S.P.A.20153—
+5K122185U-Motion II Acetabular SystemUnited Orthopedic Corp.20137—
+5K121563Corin Trifit TS HipCorin USA2012101
+6K261009MobileLink Acetabular Cup System – 40mm ID Inserts (various)Waldemar Link GmbH & Co. KG20260—
+6K243927MobileLink Acetabular Cup System - inhouse coatingsWaldemar Link GmbH & Co. KG20250—
+6K233498Stryker Orthopaedics Hip Systems Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics20234—
+6K223828BENCOX Delta Option HeadsCorentec Co., Ltd.20230—
+6K221149U-Motion II Acetabular System-Extension lineUnited Orthopedic Corporation20231—
+6K221675United U2 femoral head, 22mm delta ceramic headUnited Orthopedic Corporation20220—
+6K221404Identity Imprint Knee Replacement System (including Identity Imprint Posterior…Conformis, Inc.20226—
+6K192126AMIStem-P Short NeckMedacta International S.A.20191—
+6K181254Quadra PMedacta International S.A.20187—
+6K172833E-XPE Acetabular Components and U-Motion II Acetabular CupUnited Orthopedic Corporation20182—
+6K173880Corin TriFit CF Hip StemCorin U.S.A. Limited20183—
+6K170089U-Motion II Acetabular System— Additional sizesUnited Orthopedic Corporation20172—
+6K163441Locking Cage, Full XPE CupUnited Orthopedic Corporation20173—
+6K153772Corin TriFit TS HipCorin U.S.A. Limited20164—
+6K132455U-Motion II PS+ CupUnited Orthopedic Corp.20133—
+6K123619Intrablock Bioball Hip System (Ibs)Merete Medical GmbH20131—
+7K253948Momentum Acetabular Cup SystemUnited Orthopedic Corporation20260—
+7K261624Omnifit® 20° Series I Insert;Omnifit® Crossfire® 10° Series II Insert; Constrained…Howmedica Osteonics Corp., Dba Stryker Orthopaedics202602
+7K243784Stryker Orthopaedics Hip Devices Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics20252—
+7K240418Stryker Orthopaedics Hip Systems Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics20240—
+7K223316Identity Imprint Porous Total Knee Replacement System, Identity Imprint Porous Cruciate…Conformis, Inc.20232—
+7K230846iTotal Identity Knee Replacement System; Identity Imprint Knee Replacement SystemConformis, Inc.20232—
+7K231233Identity™ Imprint™ CR KRS and Identity™ Imprint™ PS KRSConformis, Inc.202301
+7K230844Identity Imprint Cruciate Retaining (CR) Knee Replacement System (KRS) with Cruciate…Conformis, Inc.20231—
+7K202730Quadra-PMedacta International S.A.20201—
+7K192827Quadra-PMedacta International S.A.20206—
+7K141377Bioball Delta Ceramic Heads, Multicup PE Inlay StandardMerete Medical GmbH20140—
+8K243768iTotal® Identity™ Cruciate Retaining 3DP Porous Knee Replacement SystemRestor3D, Inc.20250—
+8K232426Identity Imprint Porous Cruciate Retaining (CR) Knee Replacement System (KRS) with…Conformis, Inc.20230—
+8K220405Amis K LongMedacta International S.A.20220—
+8K210062Mectaplug PE IIMedacta International S.A.20210—
+8K203041SMS Cementless StemMedacta International S.A.20201—