510(k) Report

Devices descending from K090103

153 later devices reach 100KGY E-Poly Acetabular Liners- Additional Profiles: +3 Maxrom and +3 HI-Wall through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K151256Arthrex BioSync® Bone WedgeArthex, Inc.2015106
+4K142814Biomet Orthopaedic Salvage System (OSSTM) - Proximal Femoral & Hybrid TibialBiomet Manufacturing, LLC201516
+5K253630Mpact 3D Metal FoamMedacta International S.A.20260—
+5K253515Zimmer Biomet OSS™ Orthopedic Salvage System OsseoTi® Sleeves and AugmentsBiomet Orthopedics, Inc.20260—
+5K253728EVOLUTION® AM BIOFOAM® Tibial SystemMicroport Orthopedics, Inc.20260—
+5K261898Triathlon® Knee System; Triathlon® Hinge Knee System; Scorpio® Total Knee SystemHowmedica Osteonics Corp. dba Stryker Orthopaedics20260—
+5K261609Freedom Partial Knee SystemMaxx Orthopedics, Inc.20260—
+5K262251ACTIFY™ Total Knee System, ACTIFY™ 3D Total Knee System (ACTIFY MC Tibial Insert)Globus Medical, Inc.20260—
+5K251840Zimmer® Persona® Personalized Knee SystemZimmer, Inc.20260—
+5K253189Persona the Personalized Knee System (Persona Porous Plasma Spray PPS Femurs)Zimmer, Inc.20260—
+5K253637Triathlon® Total Knee System - Triathlon® X3® Medial Stabilized Tibial Bearing InsertHowmedica Osteonics Corp., Dba Stryker Orthopaedics20260—
+5K251043Mpact 3D Metal Implants Extension – DMLS TechnologyMedacta International S.A.20260—
+5K251771Cambridge Partial KneeSignature Orthopaedics Pty, Ltd.20250—
+5K253197ATTUNE™ Total Knee System; ATTUNE™ Revision Sleeve LPS™ Femoral AdaptorsDepuy Ireland UC20250—
+5K250450Coated hip implantsMedacta International S.A.20250—
+5K242744Trinity EVO Acetabular ShellCorin U.S.A. Limited20250—
+5K243927MobileLink Acetabular Cup System - inhouse coatingsWaldemar Link GmbH & Co. KG20250—
+5K243768iTotal® Identity™ Cruciate Retaining 3DP Porous Knee Replacement SystemRestor3D, Inc.20250—
+5K240461OsteoSinter® EVANS and COTTON wedges and related accessoriesAmes Medical Prosthetic Solutions, S.A.U.20242—
+5K242543Persona the Personalized Knee System (Persona Ti-Nidium PPS Femurs)Zimmer, Inc.20240—
+5K240299Persona the Personalized Knee System (Persona OsseoTi 3-Peg Patella)Zimmer, Inc.20243—
+5K240046Ethylene Oxide Sterilization Supplier Change for MPO HipsMicroport Orthopedics20240—
+5K232114TRIBRID® Unicompartmental Knee SystemKyocera Medical Technologies, Inc.20240—
+5K230078TRAX® CR Total Knee SystemAmplitude20230—
+5K232426Identity Imprint Porous Cruciate Retaining (CR) Knee Replacement System (KRS) with…Conformis, Inc.20230—
+5K230471LinkSymphoKnee – Fixed Bearing Ultracongruent (FB UC) Articulating SurfaceWaldemar Link GmbH & Co. KG20230—
+5K223223BENCOX Mirabo Z Cup CortiniumCorentec Co., Ltd.20230—
+5K222653JOURNEY II UK™ and ENGAGE™ Cementless Partial Knee SystemSmith+Nephew, Inc.20220—
+5K221850GMK 3D Metal Tibial TrayMedacta International S.A.20221—
+5K211567BiMobile Instruments (for BiMobile Dual Mobility System)Waldemar Link GmbH & Co. KG20220—
+5K201657Corin Ltd. Hip Products: Trinity™ Acetabular System, Trinity™ PLUS Acetabular Shell…Corin, Ltd.20212—
+5K211938Physica LMC Knee SystemLimacorporate20210—
+5K210551Persona Revision Knee SystemZimmer, Inc.202101
+5K201084Physica systemLima Corporate S.P.A.20205—
+5K193414Trigon HA Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies, Inc.20206—
+5K191831MobiliT CupCorin U.S.A. Limited20203—
+5K192645Trigon™ Ti Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies, Inc.20197—
+5K192450Precision Casting Solutions Total Hip SystemPrecision Casting Solution, LLC20190—
+5K190890Exactech Alteon Modular Dual Mobility (MDM) SystemExactech, Inc.20190—
+6K253328GMK 3D Metal Tibial Tray ExtensionMedacta International S.A.20260—
+6K252254Osteotomy Wedge SystemSinaptic Surgical20250—
+6K251791Auxano® Wedge Fixation SystemAuxano Medical, LLC20250—
+6K243231Trigon PEEK HA WedgesNvision Biomedical Technologies20241—
+6K243247Persona the Personalized Knee SystemZimmer, Inc.20240—
+6K241472Icona Hip StemCorin U.S.A. Limited20241—
+6K234116Trigon Trigon HA Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies20240—
+6K223226Trigon™ HA Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies, Inc.20220—
+6K220197Trigon HA Wedge Fixation SystemNvision Biomedical Technologies, Inc.20224—
+6K210554Physica systemLima Corporate S.P.A.20212—
+6K203445Trigon HA Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies, Inc.20205—
+7K261576Icona Hip StemCorin, Ltd.20260—
+7K250980Physica System (Physica CR Porous Femoral components)Lima Corporate S.P.A.20250—
+7K243615Physica Porous Femoral ComponentsLima Corporate S.P.A.20241—