510(k) Report

Devices descending from K921111

218 later devices reach S-Rom Zirconia Cermamic Femoral Head through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K261576Icona Hip StemCorin, Ltd.20260—
+6K243192iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with Plasma Sprayed CPTi…Nextstep Arthopedix, LLC20260—
+6K260182Avenir® Müller Stem; Avenir Complete™ Hip SystemZimmer, Inc.20260—
+6K260037implantcast Packaging System UpdateImplantcast GmbH20260—
+6K252824Evolve AP Cup, World Finned Cup, World G-Zero Liner and Oddball Femoral HeadSignature Orthopaedics Pty, Ltd.20260—
+6K252401implaFit® short stemsImplantcast GmbH20260—
+6K253171Libertas Taper Short (TS) Uncemented Femoral Stem (Libertas TS Stem)Maxx Orthopedics, Inc.20260—
+6K243043Origin™ Cemented Hip StemSignature Orthopaedics Pty, Ltd.20250—
+6K242315Resolve Modular Revision Hip StemUnited Orthopedic Corporation20250—
+6K243466Conformity Stem Extension Line, #0United Orthopedic Corporation20250—
+6K242249Conformity Stem Extension LineUnited Orthopedic Corporation20241—
+6K241690Logical Liner; World Liner; World Knee PatellaSignature Orthopaedics Pty, Ltd.20242—
+6K240046Ethylene Oxide Sterilization Supplier Change for MPO HipsMicroport Orthopedics20240—
+6K233476Z1 Hip SystemOrchard Medical Development202421
+6K232371Actinia® hip stemsImplantcast GmbH20231—
+6K231109Xerxes Hip StemXerxes Arthopedix, LLC20230—
+6K222436Latitud™ Hip Replacement SystemMeril Healthcare Pvt., Ltd.20230—
+6K221462DePuy Reclaim Monobloc Revision Femoral StemDepuy Ireland UC20226—
+6K220731Insignia Hip Stem, Restoration Modular 115mm Conical Distal StemStryker20226—
+6K221104Actera™ hip systemConformis, Inc.202211
+6K220468BENCOX Mirabo Cup SystemCorentec Co., Ltd.20221—
+6K212069Corin MetaFix™ Hip StemCorin U.S.A. Limited20222—
+6K201519PROFEMUR® GLADIATOR® Cemented Classic StemMicroport Orthopedics, Inc.20201—
+6K192989Libertas E-XLPE Modular LinerMaxx Orthopedics, Inc.20200—
+6K202484Cordera Hip SystemConformis, Inc.202022
+6K191708Origin Stem, Evolve Stem, Aria Hip Stem, Remedy Stem, CoCr Femoral HeadSignature Orthopaedics Pty, Ltd.20200—
+6K200007PROFEMUR GLADIATOR Thin HA Classic Hip Stem with CollarMicroport Orthopedics, Inc.20201—
+6K192559Acetabular Bone Screws (for MobileLink Acetabular Cup System)Waldemar Link GmbH & Co. KG20194—
+6K192189Avenir Complete Hip System, Size 0 Coxa VaraZimmer, Inc.20194—
+6K193030Avenir Muller Stem, Avenir Cemented Hip StemZimmer GmbH20193—
+6K192198Conformis Hip SystemConformis, Inc.2019121
+6K190704Signature Ceramic Femoral HeadSignature Orthopaedics Pty, Ltd.20192—
+6K183532Latitud Hip Replacement SystemMeril Healthcare Pvt., Ltd.20190—
+6K173898MicroPort Orthopedics Total Hip Systems MR LabelingMicroport Orthopedics Inc. (Mpo)20181—
+6K180263EcoFit Vit E Acetabular SystemImplantcast GmbH20185—
+6K170473C2 femoral stemLima Corporate S.P.A.20170—
+6K162942Corin MetaFix Hip StemCorin U.S.A. Limited20173—
+6K161635AMIStem-H Proximal CoatingMedacta International S.A.201710—
+6K162127Bencox M Stem Lateralized & Bencox Mirabo Cup SystemCorentec Co., Ltd.201661
+6K160011H-Max S stemLima Corporate S.P.A.20161—
+6K153131Logical C-Series Acetabular Shell, Logical Constrained Liner, Logical Constrained Liner…Signature Orthopaedics Pty, Ltd.20164—
+6K152530UCP StemUnited Orthopedic Corporation20162—
+6K150855H-MAX S Femoral Hip SystemLima Corporate S.P.A.20152—
+6K143184Evolve UniPolar HeadSignature Orthopaedics Pty, Ltd.20151—
+6K142201OMNI Interface Acetabular SystemOmnlife Science20151—
+6K141327Minima S SystemLima Corporate S.P.A.20145—
+6K133370Remedy Hip Stem, Pegasus Hip Stem, Evolve Helios Hip Stem, Evolve Masters Hip Stem…Signature Orthopaedics Pty Limited20145—
+6K131952Corin Metafix Hip StemCorin USA20134—
+6K131884Avenir Cemented Hip StemZimmer GmbH20131—
+6K130899Biolox Delta Ceramic Femoral HeadsZimmer GmbH201319—
+6K121439Metafix Femoral Hip Stem Size 1Corin USA20128—
+6K120362Metafix Femoral Stem for Hemi-ArthroplastyCorin USA201261—
+6K103518Trinity Acetabular SystemCorin USA20118—
+7K260831Z1 Hip SystemZimmer, Inc.20260—
+7K252451EPORE® XO cup systemImplantcast GmbH20260—
+7K250450Coated hip implantsMedacta International S.A.20250—
+7K251906Z1 Hip SystemZimmer, Inc.20251—
+7K243162World LinerSignature Orthopaedics Pty, Ltd.20240—
+7K241636MobileLink Acetabular Cup System - Line Extension (Multiple)Waldemar Link GmbH & Co. KG20242—
+7K241241Z1 Cemented Hip SystemOrchard Medical Development, LLC20240—
+7K240834EcoFit® short stem cementless cpTiImplantcast GmbH20241—
+7K240452Ceramic Femoral HeadMicroport Orthopedics, Inc.20240—
+7K233498Stryker Orthopaedics Hip Systems Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics20234—
+7K231925MINIMA S SystemLima Corporate S.P.A.20230—
+7K223103BethaLoc® stem cementless HAImplantcast GmbH20231—
+7K231178ACTERA™ hip systemConformis, Inc.20230—
+7K222066LINK MobileLink Acetabular Cup SystemWaldemar Link GmbH & Co. KG20230—
+7K223223BENCOX Mirabo Z Cup CortiniumCorentec Co., Ltd.20230—
+7K210614BENCOX Mirabo Z Cup CortiniumCorentec Co., Ltd.20221—
+7K221059Identity Imprint Knee Replacement System (including Identity Imprint Posterior…Conformis, Inc.20227—
+7K213816MPO Hip InstrumentsMicroport Orthopedics, Inc.20220—
+7K213389Identity Imprint Cruciate Retaining (CR) Knee Replacement System and Identity Imprint…Conformis, Inc.20218—
+7K211866Bencox THR SystemCorentec Co., Ltd.20210—
+7K201047Fusion Taper SystemSignature Orthopaedics Pty, Ltd.20210—
+7K203420EcoFit® Hip SystemImplantcast GmbH20214—
+7K192024Cemented TSI Hip StemSignature Orthopaedics Pty, Ltd.20200—
+7K200112Zimmer Hip Joint ReplacementZimmer GmbH202002
+7K191056Conformity stem, cementedUnited Orthopedic Corporation20200—
+7K192416BIOLOX Delta Ceramic Femoral Heads, BIOLOX Option Ceramic Femoral Head SystemZimmer GmbH20192—
+7K182221Bencox Mirabo Cup Multi HoleCorentec Co., Ltd.20193—
+7K182462Exactech Alteon Highly Polished Femoral StemExactech, Inc.20180—
+7K173794AMIStem-H Proximal Coating, AMIStem-P and AMIStem-P CollaredMedacta International S.A.20189—
+7K172806Bencox Mirabo Cup SystemCorentec Co., Ltd.20174—
+7K163577Ecofit® Hip SystemImplantcast GmbH201791
+7K143509MasterSL femoral stemLima Corporate S.P.A.20153—
+7K122185U-Motion II Acetabular SystemUnited Orthopedic Corp.20137—
+7K121563Corin Trifit TS HipCorin USA2012101
+8K261624Omnifit® 20° Series I Insert;Omnifit® Crossfire® 10° Series II Insert; Constrained…Howmedica Osteonics Corp., Dba Stryker Orthopaedics202602
+8K261009MobileLink Acetabular Cup System – 40mm ID Inserts (various)Waldemar Link GmbH & Co. KG20260—
+8K243927MobileLink Acetabular Cup System - inhouse coatingsWaldemar Link GmbH & Co. KG20250—
+8K243784Stryker Orthopaedics Hip Devices Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics20252—
+8K240418Stryker Orthopaedics Hip Systems Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics20240—
+8K223828BENCOX Delta Option HeadsCorentec Co., Ltd.20230—
+8K221149U-Motion II Acetabular System-Extension lineUnited Orthopedic Corporation20231—
+8K221675United U2 femoral head, 22mm delta ceramic headUnited Orthopedic Corporation20220—
+8K221404Identity Imprint Knee Replacement System (including Identity Imprint Posterior…Conformis, Inc.20226—
+8K192126AMIStem-P Short NeckMedacta International S.A.20191—
+8K181254Quadra PMedacta International S.A.20187—
+8K172833E-XPE Acetabular Components and U-Motion II Acetabular CupUnited Orthopedic Corporation20182—
+8K173880Corin TriFit CF Hip StemCorin U.S.A. Limited20183—