510(k) Report

Devices descending from K933281

553 later devices reach S.O.S. Proximal Femur through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K260173M-Vizion Femoral Revision System ExtensionMedacta International S.A.20260—
+8K262057GMK ExtensionMedacta International SA20260—
+8K261462LANDMARK Total Knee SystemSmith & Nephew, Inc.20260—
+8K261576Icona Hip StemCorin, Ltd.20260—
+8K261009MobileLink Acetabular Cup System – 40mm ID Inserts (various)Waldemar Link GmbH & Co. KG20260—
+8K251840Zimmer® Persona® Personalized Knee SystemZimmer, Inc.20260—
+8K252824Evolve AP Cup, World Finned Cup, World G-Zero Liner and Oddball Femoral HeadSignature Orthopaedics Pty, Ltd.20260—
+8K253189Persona the Personalized Knee System (Persona Porous Plasma Spray PPS Femurs)Zimmer, Inc.20260—
+8K252623G7® Revision Acetabular SystemZimmer, Inc.20260—
+8K253239Active-V Total Knee System; World Total Knee SystemSignature Orthopaedics Pty, Ltd.20250—
+8K251834Persona Partial KneeZimmer Biomet20250—
+8K250980Physica System (Physica CR Porous Femoral components)Lima Corporate S.P.A.20250—
+8K243768iTotal® Identity™ Cruciate Retaining 3DP Porous Knee Replacement SystemRestor3D, Inc.20250—
+8K243724Persona® Revision Knee System (Persona Revision SoluTion™ Femoral Components)Zimmer, Inc.20250—
+8K243574Evolution® Total Knee Systems - Kinematic Alignment Instrumentation and TechniqueMicroport Orthopedics, Inc.20251—
+8K243293Zimmer® Persona® Personalized Knee SystemZimmer Biomet20241—
+8K243615Physica Porous Femoral ComponentsLima Corporate S.P.A.20241—
+8K241260ACTIFY™ Unicondylar Knee SystemGlobus Medical, Inc.20240—
+8K242543Persona the Personalized Knee System (Persona Ti-Nidium PPS Femurs)Zimmer, Inc.20240—
+8K241636MobileLink Acetabular Cup System - Line Extension (Multiple)Waldemar Link GmbH & Co. KG20242—
+8K242412Agility Symmetric™ Total Knee SystemMedisurge, LLC20240—
+8K242711JOURNEY II Unicompartmental Knee System (JOURNEY II UK)Smith & Nephew, Inc.20240—
+8K240783Anthology Hip Stems; CPCS Hip Stems; Femoral Heads; R3 Acetabular Liners; Spectron Hip…Smith & Nephew, Inc.20240—
+8K242375OR3O Dual Mobility SystemSmith & Nephew, Inc.20240—
+8K241570Unity Total Knee SystemCorin U.S.A. Limited20240—
+8K241690Logical Liner; World Liner; World Knee PatellaSignature Orthopaedics Pty, Ltd.20242—
+8K240299Persona the Personalized Knee System (Persona OsseoTi 3-Peg Patella)Zimmer, Inc.20243—
+8K230120KeYi Total Knee SystemBeijing Keyi Medical Device Technology Co., Ltd.20240—
+8K233093Balanced Knee® System TriMax PS Plus Tibial InsertOrtho Development Corporation20230—
+8K230011Mpact ExtensionMedacta International S.A.20233—
+8K232426Identity Imprint Porous Cruciate Retaining (CR) Knee Replacement System (KRS) with…Conformis, Inc.20230—
+8K223316Identity Imprint Porous Total Knee Replacement System, Identity Imprint Porous Cruciate…Conformis, Inc.20232—
+8K231448TANDEM Hip SystemSmith & Nephew, Inc.202301
+8K231925MINIMA S SystemLima Corporate S.P.A.20230—
+8K223828BENCOX Delta Option HeadsCorentec Co., Ltd.20230—
+8K230321Persona™ Personalized Knee SystemZimmer, Inc.20230—
+8K223223BENCOX Mirabo Z Cup CortiniumCorentec Co., Ltd.20230—
+8K210678implaFit® hip stemsImplantcast GmbH20223—
+8K221404Identity Imprint Knee Replacement System (including Identity Imprint Posterior…Conformis, Inc.20226—
+8K212870TLC Unicompartmental Knee SystemSignature Orthopaedics Pty, Ltd.20222—
+8K210614BENCOX Mirabo Z Cup CortiniumCorentec Co., Ltd.20221—
+8K213381Physica systemLima Corporate S.P.A.202101
+8K211609ATTUNE Medial Stabilized (MS) Fixed Bearing (FB) InsertDepuy Ireland UC20212—
+8K211938Physica LMC Knee SystemLimacorporate20210—
+8K210829Persona Revision Knee System Femoral Metaphyseal ConesZimmer, Inc.20210—
+8K200959Biolox® delta Ceramic Heads, Biolox® delta Option Ceramic Heads MR LabelingBiomet UK, Ltd.20200—
+8K201343Triathlon Total KneeSystemHowmedica Osteonics Corp., Dba Stryker Orthopaedics20203—
+8K200112Zimmer Hip Joint ReplacementZimmer GmbH202002
+8K200151Persona Partial Knee Tibial Cut Guide 5 Deg Left Medial Right Lateral, Persona Partial…Zimmer, Inc.20200—
+8K193223Persona Personalized Knee SystemZimmer, Inc.20203—
+8K192559Acetabular Bone Screws (for MobileLink Acetabular Cup System)Waldemar Link GmbH & Co. KG20194—
+8K191625Persona Revision Knee SystemZimmer, Inc.201911
+8K191211JOURNEY II Unicompartmental Knee SystemSmith & Nephew, Inc.20191—
+8K183532Latitud Hip Replacement SystemMeril Healthcare Pvt., Ltd.20190—
+8K190085Journey II Unicompartmental Knee SystemSmith & Nephew, Inc.201973
+8K180973Libertas Hip Replacement SystemMaxx Orthopedics, Inc.20183—
+8K173890GMK Sphere - Kinematic AlignmentMedacta International S.A.20186—
+8K172857Latitud Hip Replacement SystemMeril Healthcare Pvt., Ltd.20185—
+8K172551Trinity PLUS Acetabular ShellCorin U.S.A. Limited20184—
+8K180906Conformis iTotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc.2018174
+8K173723EMPOWR Universal Tibial BaseplateEncore Medical L.P.201821
+8K172651FMP Extended LinersEncore Medical L.P.20173—
+8K172806Bencox Mirabo Cup SystemCorentec Co., Ltd.20174—
+8K171991EMPOWR Porous Knee SystemEncore Medical L.P.201713
+8K170573Empowr CR Knee Tibial InsertEncore Medical L.P.20170—
+8K162127Bencox M Stem Lateralized & Bencox Mirabo Cup SystemCorentec Co., Ltd.201661
+8K162024AltiVate Anatomic Shoulder SystemEncore Medical L.P.2016346
+8K151424The Progressive Orthopaedic Total Hip SystemThe Progressive Orthopaedic Company, LLC20161—
+8K152893Corin Optimized Positioning System (OPS)Corin USA20168—
+8K160342EMPOWR PS Knee SystemEncore Medical L.P.201665
+8K152169Balanced Knee System TriMax CR Femoral Component and E-Vitalize CR and UC Tibial InsertsOrtho Development Corporation20151—
+8K151256Arthrex BioSync® Bone WedgeArthex, Inc.2015106
+8K142814Biomet Orthopaedic Salvage System (OSSTM) - Proximal Femoral & Hybrid TibialBiomet Manufacturing, LLC201516
+8K142761Corin TaperFit Hip StemCorin USA201541
+8K143509MasterSL femoral stemLima Corporate S.P.A.20153—
+8K140130X-Alt Highly Cross Linked Acetabular Liners with Vitamin E, Neutral, 10 Degree Hooded…Encore Medical L.P.20141—
+8K140830Exprt Revision KneeEncore Medical L.P.201471
+8K140833Itotal Posterior Stabilized (PS) Knee Replacement SystemConformis, Inc.201426—
+8K141006RSP Humeral Socket InsertDjo Global2014212
+8K140423Itotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc.2014251
+8K132158Novohip Total Hip SystemNovosource, Inc.201461
+8K133256Itotal Cruciate Retaining, Iuni Unicondylar Knee Replacement Systems, Iduo…Conformis, Inc.2014166
+8K131647Trinity Acetabular SystemCorin USA201322—
+8K130343Corin Trinity Acetabular System with Extra-Long HeadsCorin USA2013332
+8K130128Trinity Acetabular SystemCorin Medical201317—
+8K123705Trinity Non-Occluded Titanium Plasma Sprayed (TPS) Acetabular ShellsCorin USA2013234
+8K122305Corin Trinity-I Acetabular ShellCorin USA201228—
+8K121835Domed Tri-Peg Patella, Highly Cross Linked Domed Tri-Peg Patella with VEEncore Medical L.P.20120—
+8K111481Corin Trinity Acetabular System Ecima LinersCorin USA2012331
+8K111936Ortho Devlopment Ceramic Femoral HeadOrtho Development20110—
+8K111911Corin Optimom Modular HeadCorin USA201162—
+8K083495Modification to: Metha Hip SystemAesculap Implant Systems, Inc.200959—
+9K253630Mpact 3D Metal FoamMedacta International S.A.20260—
+9K253515Zimmer Biomet OSS™ Orthopedic Salvage System OsseoTi® Sleeves and AugmentsBiomet Orthopedics, Inc.20260—
+9K253728EVOLUTION® AM BIOFOAM® Tibial SystemMicroport Orthopedics, Inc.20260—
+9K261898Triathlon® Knee System; Triathlon® Hinge Knee System; Scorpio® Total Knee SystemHowmedica Osteonics Corp. dba Stryker Orthopaedics20260—
+9K261609Freedom Partial Knee SystemMaxx Orthopedics, Inc.20260—
+9K252401implaFit® short stemsImplantcast GmbH20260—
+9K253637Triathlon® Total Knee System - Triathlon® X3® Medial Stabilized Tibial Bearing InsertHowmedica Osteonics Corp., Dba Stryker Orthopaedics20260—
+9K251043Mpact 3D Metal Implants Extension – DMLS TechnologyMedacta International S.A.20260—