510(k) Report

Devices descending from K970501

509 later devices reach Pegged Acetabular Component through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K183532Latitud Hip Replacement SystemMeril Healthcare Pvt., Ltd.20190—
+7K190085Journey II Unicompartmental Knee SystemSmith & Nephew, Inc.201973
+7K180973Libertas Hip Replacement SystemMaxx Orthopedics, Inc.20183—
+7K173890GMK Sphere - Kinematic AlignmentMedacta International S.A.20186—
+7K172857Latitud Hip Replacement SystemMeril Healthcare Pvt., Ltd.20185—
+7K172551Trinity PLUS Acetabular ShellCorin U.S.A. Limited20184—
+7K180906Conformis iTotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc.2018174
+7K173723EMPOWR Universal Tibial BaseplateEncore Medical L.P.201821
+7K172651FMP Extended LinersEncore Medical L.P.20173—
+7K172806Bencox Mirabo Cup SystemCorentec Co., Ltd.20174—
+7K171991EMPOWR Porous Knee SystemEncore Medical L.P.201713
+7K170573Empowr CR Knee Tibial InsertEncore Medical L.P.20170—
+7K162127Bencox M Stem Lateralized & Bencox Mirabo Cup SystemCorentec Co., Ltd.201661
+7K162024AltiVate Anatomic Shoulder SystemEncore Medical L.P.2016346
+7K151424The Progressive Orthopaedic Total Hip SystemThe Progressive Orthopaedic Company, LLC20161—
+7K152893Corin Optimized Positioning System (OPS)Corin USA20168—
+7K160342EMPOWR PS Knee SystemEncore Medical L.P.201665
+7K152169Balanced Knee System TriMax CR Femoral Component and E-Vitalize CR and UC Tibial InsertsOrtho Development Corporation20151—
+7K151256Arthrex BioSync® Bone WedgeArthex, Inc.2015106
+7K142814Biomet Orthopaedic Salvage System (OSSTM) - Proximal Femoral & Hybrid TibialBiomet Manufacturing, LLC201516
+7K142761Corin TaperFit Hip StemCorin USA201541
+7K143509MasterSL femoral stemLima Corporate S.P.A.20153—
+7K140130X-Alt Highly Cross Linked Acetabular Liners with Vitamin E, Neutral, 10 Degree Hooded…Encore Medical L.P.20141—
+7K140830Exprt Revision KneeEncore Medical L.P.201471
+7K140833Itotal Posterior Stabilized (PS) Knee Replacement SystemConformis, Inc.201426—
+7K141006RSP Humeral Socket InsertDjo Global2014212
+7K140423Itotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc.2014251
+7K132158Novohip Total Hip SystemNovosource, Inc.201461
+7K133256Itotal Cruciate Retaining, Iuni Unicondylar Knee Replacement Systems, Iduo…Conformis, Inc.2014166
+7K131647Trinity Acetabular SystemCorin USA201322—
+7K130343Corin Trinity Acetabular System with Extra-Long HeadsCorin USA2013332
+7K130128Trinity Acetabular SystemCorin Medical201317—
+7K123705Trinity Non-Occluded Titanium Plasma Sprayed (TPS) Acetabular ShellsCorin USA2013234
+7K122305Corin Trinity-I Acetabular ShellCorin USA201228—
+7K121835Domed Tri-Peg Patella, Highly Cross Linked Domed Tri-Peg Patella with VEEncore Medical L.P.20120—
+7K111481Corin Trinity Acetabular System Ecima LinersCorin USA2012331
+7K111936Ortho Devlopment Ceramic Femoral HeadOrtho Development20110—
+7K111911Corin Optimom Modular HeadCorin USA201162—
+7K083495Modification to: Metha Hip SystemAesculap Implant Systems, Inc.200959—
+8K253630Mpact 3D Metal FoamMedacta International S.A.20260—
+8K253515Zimmer Biomet OSS™ Orthopedic Salvage System OsseoTi® Sleeves and AugmentsBiomet Orthopedics, Inc.20260—
+8K253728EVOLUTION® AM BIOFOAM® Tibial SystemMicroport Orthopedics, Inc.20260—
+8K261898Triathlon® Knee System; Triathlon® Hinge Knee System; Scorpio® Total Knee SystemHowmedica Osteonics Corp. dba Stryker Orthopaedics20260—
+8K261609Freedom Partial Knee SystemMaxx Orthopedics, Inc.20260—
+8K252401implaFit® short stemsImplantcast GmbH20260—
+8K253637Triathlon® Total Knee System - Triathlon® X3® Medial Stabilized Tibial Bearing InsertHowmedica Osteonics Corp., Dba Stryker Orthopaedics20260—
+8K251043Mpact 3D Metal Implants Extension – DMLS TechnologyMedacta International S.A.20260—
+8K253171Libertas Taper Short (TS) Uncemented Femoral Stem (Libertas TS Stem)Maxx Orthopedics, Inc.20260—
+8K253161Balanced Knee System TriMax Porous Femoral ComponentsOrtho Development Corp.20250—
+8K251771Cambridge Partial KneeSignature Orthopaedics Pty, Ltd.20250—
+8K253197ATTUNE™ Total Knee System; ATTUNE™ Revision Sleeve LPS™ Femoral AdaptorsDepuy Ireland UC20250—
+8K250450Coated hip implantsMedacta International S.A.20250—
+8K251184AltiVate Reverse Shoulder System; RSP Shoulder System; SMR Shoulder System; PRIMA…Encore Medical L.P.20250—
+8K243927MobileLink Acetabular Cup System - inhouse coatingsWaldemar Link GmbH & Co. KG20250—
+8K243768iTotal® Identity™ Cruciate Retaining 3DP Porous Knee Replacement SystemRestor3D, Inc.20250—
+8K240461OsteoSinter® EVANS and COTTON wedges and related accessoriesAmes Medical Prosthetic Solutions, S.A.U.20242—
+8K243162World LinerSignature Orthopaedics Pty, Ltd.20240—
+8K243247Persona the Personalized Knee SystemZimmer, Inc.20240—
+8K232114TRIBRID® Unicompartmental Knee SystemKyocera Medical Technologies, Inc.20240—
+8K230078TRAX® CR Total Knee SystemAmplitude20230—
+8K232371Actinia® hip stemsImplantcast GmbH20231—
+8K232426Identity Imprint Porous Cruciate Retaining (CR) Knee Replacement System (KRS) with…Conformis, Inc.20230—
+8K222436Latitud™ Hip Replacement SystemMeril Healthcare Pvt., Ltd.20230—
+8K230471LinkSymphoKnee – Fixed Bearing Ultracongruent (FB UC) Articulating SurfaceWaldemar Link GmbH & Co. KG20230—
+8K222653JOURNEY II UK™ and ENGAGE™ Cementless Partial Knee SystemSmith+Nephew, Inc.20220—
+8K221850GMK 3D Metal Tibial TrayMedacta International S.A.20221—
+8K213387AltiVate® Anatomic Shoulder AG e+™ with MarkersEncore Medical L.P.20221—
+8K213793EMPOWR Revision KneeEncore Medical L.P.20221—
+8K212800PRIMA Humeral System and SMR Glenosphere Ø42Lima Corporate S.P.A.202222
+8K211866Bencox THR SystemCorentec Co., Ltd.20210—
+8K202716Ignite Anatomic Shoulder SystemIgnite Orthopedics, LLC202113—
+8K203421Triathlon AS-1Conformis, Inc.20210—
+8K210308EMPOWR Porous Femur with HAnano SurfaceTMEncore Medical L.P.20210—
+8K210551Persona Revision Knee SystemZimmer, Inc.202101
+8K203026AltiVate® Anatomic Pegged Glenoid with MarkersEncore Medical L.P.20202—
+8K201905SMR 140° Reverse Humeral BodyLima Corporate S.P.A.20200—
+8K202098GLOBAL UNITE™ Platform Shoulder SystemDepuy Ireland UC20201—
+8K202373APEX 3D Total Ankle Replacement SystemParagon 28, Inc.20200—
+8K192989Libertas E-XLPE Modular LinerMaxx Orthopedics, Inc.20200—
+8K193226AltiVate Anatomic Canal-Sparing (CS) ShoulderEncore Medical L.P.20204—
+8K193105iUni Unicondylar Knee Replacement System, iDuo Bicompartmental Knee Repair System…Conformis, Inc.202015—
+8K193414Trigon HA Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies, Inc.20206—
+8K192645Trigon™ Ti Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies, Inc.20197—
+8K192450Precision Casting Solutions Total Hip SystemPrecision Casting Solution, LLC20190—
+8K190562iTotal Identity Cruciate Retaining Knee Replacement SystemConformis, Inc.201915—
+8K190834Corin Optimized Position System Functional Hip Analysis (OPS FHA)Corin USA20195—
+8K190290AltiVate Reverse Humeral Stem, 48mmEncore Medical L.P.201915—
+8K181061Corin Optimized Positioning System (OPS) FemoralCorin USA20181—
+8K180930Empowr VVC Tibial InsertEncore Medical L.P.201831
+8K173583Exactech® Novation® and AcuMatch® E-HXL Acetabular LinersExactech, Inc.201833
+8K173073AltiVate Anatomic to Reverse Conversion ModuleEncore Medical L.P.20173—
+8K172351AltiVate Reverse Humeral Stem, AltiVate Reverse Small Spacer, Altivate Reverse, Small…Encore Medical L.P.2017183
+8K161945EXPRT Revision Knee Femoral Augment (5mm), EXPRT Revision Knee Stem Extension (40mm)Encore Medical L.P.20160—
+8K153725Corin TaperFit Hip StemCorin U.S.A. Limited20163—
+8K143314Progressive Orthopaedic Total Hip SystemThe Progressive Orthopaedic Company, LLC20152—
+8K142404iTotal Posterior Stabilized (PS) Knee Replacement SystemConformis, Inc.2014242
+8K142161Itotal Cruciate Retaining (CR) Knee Replacement System, Itotal Posterior Stabilized (PS)…Conformis, Inc.2014246
+8K131952Corin Metafix Hip StemCorin USA20134—
+8K131986Corin Minihip StemCorin USA20133—
+8K120362Metafix Femoral Stem for Hemi-ArthroplastyCorin USA201261—