510(k) Report

Devices descending from K032396

505 later devices reach Ringloc 36MM Line and Modular Femoral Heads through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K173723EMPOWR Universal Tibial BaseplateEncore Medical L.P.201821
+6K172651FMP Extended LinersEncore Medical L.P.20173—
+6K172806Bencox Mirabo Cup SystemCorentec Co., Ltd.20174—
+6K171991EMPOWR Porous Knee SystemEncore Medical L.P.201713
+6K170573Empowr CR Knee Tibial InsertEncore Medical L.P.20170—
+6K162127Bencox M Stem Lateralized & Bencox Mirabo Cup SystemCorentec Co., Ltd.201661
+6K162024AltiVate Anatomic Shoulder SystemEncore Medical L.P.2016346
+6K151424The Progressive Orthopaedic Total Hip SystemThe Progressive Orthopaedic Company, LLC20161—
+6K152893Corin Optimized Positioning System (OPS)Corin USA20168—
+6K160342EMPOWR PS Knee SystemEncore Medical L.P.201665
+6K152169Balanced Knee System TriMax CR Femoral Component and E-Vitalize CR and UC Tibial InsertsOrtho Development Corporation20151—
+6K151256Arthrex BioSync® Bone WedgeArthex, Inc.2015106
+6K142814Biomet Orthopaedic Salvage System (OSSTM) - Proximal Femoral & Hybrid TibialBiomet Manufacturing, LLC201516
+6K142761Corin TaperFit Hip StemCorin USA201541
+6K143509MasterSL femoral stemLima Corporate S.P.A.20153—
+6K140130X-Alt Highly Cross Linked Acetabular Liners with Vitamin E, Neutral, 10 Degree Hooded…Encore Medical L.P.20141—
+6K140830Exprt Revision KneeEncore Medical L.P.201471
+6K140833Itotal Posterior Stabilized (PS) Knee Replacement SystemConformis, Inc.201426—
+6K141006RSP Humeral Socket InsertDjo Global2014212
+6K140423Itotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc.2014251
+6K132158Novohip Total Hip SystemNovosource, Inc.201461
+6K133256Itotal Cruciate Retaining, Iuni Unicondylar Knee Replacement Systems, Iduo…Conformis, Inc.2014166
+6K131647Trinity Acetabular SystemCorin USA201322—
+6K130343Corin Trinity Acetabular System with Extra-Long HeadsCorin USA2013332
+6K130128Trinity Acetabular SystemCorin Medical201317—
+6K123705Trinity Non-Occluded Titanium Plasma Sprayed (TPS) Acetabular ShellsCorin USA2013234
+6K122305Corin Trinity-I Acetabular ShellCorin USA201228—
+6K121835Domed Tri-Peg Patella, Highly Cross Linked Domed Tri-Peg Patella with VEEncore Medical L.P.20120—
+6K111481Corin Trinity Acetabular System Ecima LinersCorin USA2012331
+6K111936Ortho Devlopment Ceramic Femoral HeadOrtho Development20110—
+6K111911Corin Optimom Modular HeadCorin USA201162—
+6K083495Modification to: Metha Hip SystemAesculap Implant Systems, Inc.200959—
+7K253630Mpact 3D Metal FoamMedacta International S.A.20260—
+7K253515Zimmer Biomet OSS™ Orthopedic Salvage System OsseoTi® Sleeves and AugmentsBiomet Orthopedics, Inc.20260—
+7K253728EVOLUTION® AM BIOFOAM® Tibial SystemMicroport Orthopedics, Inc.20260—
+7K261898Triathlon® Knee System; Triathlon® Hinge Knee System; Scorpio® Total Knee SystemHowmedica Osteonics Corp. dba Stryker Orthopaedics20260—
+7K261609Freedom Partial Knee SystemMaxx Orthopedics, Inc.20260—
+7K252401implaFit® short stemsImplantcast GmbH20260—
+7K253637Triathlon® Total Knee System - Triathlon® X3® Medial Stabilized Tibial Bearing InsertHowmedica Osteonics Corp., Dba Stryker Orthopaedics20260—
+7K251043Mpact 3D Metal Implants Extension – DMLS TechnologyMedacta International S.A.20260—
+7K253171Libertas Taper Short (TS) Uncemented Femoral Stem (Libertas TS Stem)Maxx Orthopedics, Inc.20260—
+7K253161Balanced Knee System TriMax Porous Femoral ComponentsOrtho Development Corp.20250—
+7K251771Cambridge Partial KneeSignature Orthopaedics Pty, Ltd.20250—
+7K253197ATTUNE™ Total Knee System; ATTUNE™ Revision Sleeve LPS™ Femoral AdaptorsDepuy Ireland UC20250—
+7K250450Coated hip implantsMedacta International S.A.20250—
+7K251184AltiVate Reverse Shoulder System; RSP Shoulder System; SMR Shoulder System; PRIMA…Encore Medical L.P.20250—
+7K243927MobileLink Acetabular Cup System - inhouse coatingsWaldemar Link GmbH & Co. KG20250—
+7K243768iTotal® Identity™ Cruciate Retaining 3DP Porous Knee Replacement SystemRestor3D, Inc.20250—
+7K240461OsteoSinter® EVANS and COTTON wedges and related accessoriesAmes Medical Prosthetic Solutions, S.A.U.20242—
+7K243162World LinerSignature Orthopaedics Pty, Ltd.20240—
+7K243247Persona the Personalized Knee SystemZimmer, Inc.20240—
+7K232114TRIBRID® Unicompartmental Knee SystemKyocera Medical Technologies, Inc.20240—
+7K230078TRAX® CR Total Knee SystemAmplitude20230—
+7K232371Actinia® hip stemsImplantcast GmbH20231—
+7K232426Identity Imprint Porous Cruciate Retaining (CR) Knee Replacement System (KRS) with…Conformis, Inc.20230—
+7K230846iTotal Identity Knee Replacement System; Identity Imprint Knee Replacement SystemConformis, Inc.20232—
+7K231233Identity™ Imprint™ CR KRS and Identity™ Imprint™ PS KRSConformis, Inc.202301
+7K222436Latitud™ Hip Replacement SystemMeril Healthcare Pvt., Ltd.20230—
+7K230844Identity Imprint Cruciate Retaining (CR) Knee Replacement System (KRS) with Cruciate…Conformis, Inc.20231—
+7K230471LinkSymphoKnee – Fixed Bearing Ultracongruent (FB UC) Articulating SurfaceWaldemar Link GmbH & Co. KG20230—
+7K222653JOURNEY II UK™ and ENGAGE™ Cementless Partial Knee SystemSmith+Nephew, Inc.20220—
+7K221850GMK 3D Metal Tibial TrayMedacta International S.A.20221—
+7K213387AltiVate® Anatomic Shoulder AG e+™ with MarkersEncore Medical L.P.20221—
+7K213793EMPOWR Revision KneeEncore Medical L.P.20221—
+7K212800PRIMA Humeral System and SMR Glenosphere Ø42Lima Corporate S.P.A.202222
+7K211866Bencox THR SystemCorentec Co., Ltd.20210—
+7K202716Ignite Anatomic Shoulder SystemIgnite Orthopedics, LLC202113—
+7K203421Triathlon AS-1Conformis, Inc.20210—
+7K210308EMPOWR Porous Femur with HAnano SurfaceTMEncore Medical L.P.20210—
+7K210551Persona Revision Knee SystemZimmer, Inc.202101
+7K203026AltiVate® Anatomic Pegged Glenoid with MarkersEncore Medical L.P.20202—
+7K201905SMR 140° Reverse Humeral BodyLima Corporate S.P.A.20200—
+7K202098GLOBAL UNITE™ Platform Shoulder SystemDepuy Ireland UC20201—
+7K202373APEX 3D Total Ankle Replacement SystemParagon 28, Inc.20200—
+7K192989Libertas E-XLPE Modular LinerMaxx Orthopedics, Inc.20200—
+7K193226AltiVate Anatomic Canal-Sparing (CS) ShoulderEncore Medical L.P.20204—
+7K193105iUni Unicondylar Knee Replacement System, iDuo Bicompartmental Knee Repair System…Conformis, Inc.202015—
+7K193414Trigon HA Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies, Inc.20206—
+7K192645Trigon™ Ti Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies, Inc.20197—
+7K192450Precision Casting Solutions Total Hip SystemPrecision Casting Solution, LLC20190—
+7K190562iTotal Identity Cruciate Retaining Knee Replacement SystemConformis, Inc.201915—
+7K190834Corin Optimized Position System Functional Hip Analysis (OPS FHA)Corin USA20195—
+7K190290AltiVate Reverse Humeral Stem, 48mmEncore Medical L.P.201915—
+7K181061Corin Optimized Positioning System (OPS) FemoralCorin USA20181—
+7K180930Empowr VVC Tibial InsertEncore Medical L.P.201831
+7K173583Exactech® Novation® and AcuMatch® E-HXL Acetabular LinersExactech, Inc.201833
+7K173073AltiVate Anatomic to Reverse Conversion ModuleEncore Medical L.P.20173—
+7K172351AltiVate Reverse Humeral Stem, AltiVate Reverse Small Spacer, Altivate Reverse, Small…Encore Medical L.P.2017183
+7K161945EXPRT Revision Knee Femoral Augment (5mm), EXPRT Revision Knee Stem Extension (40mm)Encore Medical L.P.20160—
+7K153725Corin TaperFit Hip StemCorin U.S.A. Limited20163—
+7K143314Progressive Orthopaedic Total Hip SystemThe Progressive Orthopaedic Company, LLC20152—
+7K142404iTotal Posterior Stabilized (PS) Knee Replacement SystemConformis, Inc.2014242
+7K142161Itotal Cruciate Retaining (CR) Knee Replacement System, Itotal Posterior Stabilized (PS)…Conformis, Inc.2014246
+7K131952Corin Metafix Hip StemCorin USA20134—
+7K131986Corin Minihip StemCorin USA20133—
+7K120362Metafix Femoral Stem for Hemi-ArthroplastyCorin USA201261—
+7K090845Apex Arc Hip StemOmni Life Science, Inc.2010582
+8K253328GMK 3D Metal Tibial Tray ExtensionMedacta International S.A.20260—
+8K252254Osteotomy Wedge SystemSinaptic Surgical20250—
+8K251791Auxano® Wedge Fixation SystemAuxano Medical, LLC20250—