510(k) Report

Devices descending from K945115

537 later devices reach Mallory-Head Modular Calcar Repacement Components through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+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—
+8K223316Identity Imprint Porous Total Knee Replacement System, Identity Imprint Porous Cruciate…Conformis, Inc.20232—
+8K231448TANDEM Hip SystemSmith & Nephew, Inc.202301
+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
+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—
+9K253171Libertas Taper Short (TS) Uncemented Femoral Stem (Libertas TS Stem)Maxx Orthopedics, Inc.20260—
+9K253161Balanced Knee System TriMax Porous Femoral ComponentsOrtho Development Corp.20250—
+9K251771Cambridge Partial KneeSignature Orthopaedics Pty, Ltd.20250—
+9K253197ATTUNE™ Total Knee System; ATTUNE™ Revision Sleeve LPS™ Femoral AdaptorsDepuy Ireland UC20250—
+9K250450Coated hip implantsMedacta International S.A.20250—
+9K251184AltiVate Reverse Shoulder System; RSP Shoulder System; SMR Shoulder System; PRIMA…Encore Medical L.P.20250—
+9K243927MobileLink Acetabular Cup System - inhouse coatingsWaldemar Link GmbH & Co. KG20250—
+9K243768iTotal® Identity™ Cruciate Retaining 3DP Porous Knee Replacement SystemRestor3D, Inc.20250—
+9K240461OsteoSinter® EVANS and COTTON wedges and related accessoriesAmes Medical Prosthetic Solutions, S.A.U.20242—
+9K243162World LinerSignature Orthopaedics Pty, Ltd.20240—
+9K243247Persona the Personalized Knee SystemZimmer, Inc.20240—
+9K232114TRIBRID® Unicompartmental Knee SystemKyocera Medical Technologies, Inc.20240—
+9K230078TRAX® CR Total Knee SystemAmplitude20230—
+9K232371Actinia® hip stemsImplantcast GmbH20231—
+9K232426Identity Imprint Porous Cruciate Retaining (CR) Knee Replacement System (KRS) with…Conformis, Inc.20230—
+9K230846iTotal Identity Knee Replacement System; Identity Imprint Knee Replacement SystemConformis, Inc.20232—
+9K231233Identity™ Imprint™ CR KRS and Identity™ Imprint™ PS KRSConformis, Inc.202301
+9K222436Latitud™ Hip Replacement SystemMeril Healthcare Pvt., Ltd.20230—
+9K230844Identity Imprint Cruciate Retaining (CR) Knee Replacement System (KRS) with Cruciate…Conformis, Inc.20231—
+9K230471LinkSymphoKnee – Fixed Bearing Ultracongruent (FB UC) Articulating SurfaceWaldemar Link GmbH & Co. KG20230—
+9K222653JOURNEY II UK™ and ENGAGE™ Cementless Partial Knee SystemSmith+Nephew, Inc.20220—
+9K221850GMK 3D Metal Tibial TrayMedacta International S.A.20221—
+9K213387AltiVate® Anatomic Shoulder AG e+™ with MarkersEncore Medical L.P.20221—
+9K213793EMPOWR Revision KneeEncore Medical L.P.20221—
+9K212800PRIMA Humeral System and SMR Glenosphere Ø42Lima Corporate S.P.A.202222
+9K211866Bencox THR SystemCorentec Co., Ltd.20210—
+9K202716Ignite Anatomic Shoulder SystemIgnite Orthopedics, LLC202113—
+9K203421Triathlon AS-1Conformis, Inc.20210—