510(k) Report

Devices descending from K042021

71 later devices reach Exactech Equinoxe Shoulder System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K173388Exactech Equinoxe Stemless ShoulderExactech, Inc.20189—
+1K162726Exactech® Equinoxe® Preserve StemExactech, Inc.201731
+1K150568ARROW Humeral stems size 6 and 16Fournitures Hospitalieres Industrie20154—
+1K140063Equinoxe Extra Short Humeral HeadExactech, Inc.201410—
+1K121067Exactech Equinoxe Shoulder System Torque Defining Screw and Short Replicator PlateExactech, Inc.20120—
+1K113309Exactech Equinoxe Cage GlenoidsExactech, Inc.201138
+1K110706Exactech Equinoxe Cuff Tear Arthroplasty (Cta) HeadExactech, Inc.20110—
+1K103419Exactech Equinoxe R Uhmwpe Posterior Augment Pegged Glenoids TMExactech, Inc.2010222
+1K093599Arrow Anatomical Shoulder SystemFournitures Hospitalieres Industrie201011—
+1K102951Exactech Equinox Fixed Angle Replicator Plate (0MM,1.5MM,4.5MM), Humeral Head-Short…Exactech, Inc.201072
+1K093430Exactech Equinoxe XL Keeled Glenoid, Pegged Glenoid, Exactech Equinoxe Cage, Glenoid…Exactech, Inc.2010241
+1K092900Exactech Equinoxe Platform Fracture Stem and Revision Platform Fracture StemExactech, Inc.201022
+1K061454Exactech Equinoxe Shoulder StemsExactech, Inc.200616—
+1K060535Spacer-S Temporary Shoulder SpacerTecres S.P.A.20068—
+2K250713Equinoxe® Humeral Reconstruction Prosthesis; Equinoxe® Stemless Shoulder ImplantsExactech, Inc.20250—
+2K253345JARVIS Diaphyseal Stem StandardFH Industrie20251—
+2K232226ARROW Off-Centred Humeral InsertFH Industrie20230—
+2K222592AltiVate® Anatomic Shoulder AG e+™ with MarkersEncore Medical L.P.20230—
+2K212356Exactech® Equinoxe® Laser Cage GlenoidExactech, Inc.202221
+2K202024ARROW Short Stem Humeral SystemFH Industrie20212—
+2K203108Ignite Stemless Anatomic Shoulder SystemIgnite Orthopedics, LLC20213—
+2K192097Exactech® Equinoxe® Stemless Humeral ComponentsExactech, Inc.20201—
+2K182516Comprehensive Nano Stemless ShoulderBiomet Manufacturing Corp20196—
+2K180632Exactech Equinoxe Small Reverse Shoulder SystemExactech, Inc.201853
+2K162068ARROW Anatomical Porous glenoidFournitures Hospitalieres Industrie20174—
+2K152267Remedy® Shoulder SpacerOsteoremedies, LLC20152—
+2K131277Seviin Fracture ShoulderIngen Orthopedics, LLC20130—
+2K112193Arrow Reverse Shoulder SystemFournitures Hospitalieres Industrie201210—
+2K112983Spacer-STecres S.P.A.20117—
+2K111379Equinoxe Uhmwpe 12* Posterior Augment Pegged Glenoid, Small / Medium / Large /…Exactech, Inc.2011212
+2K101909Exactech Equinoxe, Platform Fracture StemExactech, Inc.201004
+3K254084AETOS Shoulder System - CONCELOC GlenoidsSmith & Nephew, Inc.20260—
+3K254003JARVIS Metaphyseal StemFH Industrie20260—
+3K252443SpaceFix Shoulder SpacerG21, S.R.L.20250—
+3K243248Inhance Intact™Depuy Ireland UC20240—
+3K241873OsseoFit Stemless Shoulder SystemZimmer, Inc.20241—
+3K242253JARVIS Glenoid Reverse Shoulder ProsthesisFH Industrie20241—
+3K240856Hip Spacer Molds; Knee Spacer Molds; Shoulder Spacer MoldsOsartis GmbH20240—
+3K231099SMR Hybrid Glenoid SystemLima Corporate S.P.A.20230—
+3K230831INHANCE Shoulder System Convertible Glenoid Inserts, INHANCE Convertible GlenoidDepuy Ireland UC20230—
+3K223833Exactech® Equinoxe® Reverse Humeral Liners and Humeral Adapter TraysExactech, Inc.202321
+3K223211INHANCETM Shoulder System – Humeral Stems and StemlessDepuy Ireland UC20220—
+3K202338SpaceFlex ShoulderG21, S.R.L.20211—
+3K182536Exactech Equinoxe Small Reverse Shoulder Glenospheres , Exactech Equinoxe Reverse…Exactech, Inc.201843
+3K171789ARROW Reverse Porous GlenoidFournitures Hospitalieres Industrie20183—
+3K160071StageOne Disposable Cement Spacer Molds for Temporary Hemi-Shoulder ProsthesisBiomet, Inc.201635
+3K142778ARROW Reverse Shoulder long keel and short keel glenoid baseFournitures Hospitalieres Industrie20155—
+3K131135Biomet Stage One Disposable Cement Spacer Molds for Temporary Hemi-Shoulder ProsthesisBiomet Manufacturing Corp201445
+3K121220Equinoxe Glenoid, Uhmwpe 16 PS=Osterior Augment Pegged, Small, Left/RightExactech, Inc.2012202
+4K262955OsseoFit Stemless Shoulder SystemZimmer, Inc.20260—
+4K260583Equinoxe® Shoulder SystemExactech, Inc.20260—
+4K252411JARVIS Glenoid Reverse Shoulder ProsthesisFH Industrie20250—
+4K243448Equinoxe® Shoulder SystemExactech, Inc.20250—
+4K233482Equinoxe® Central Screw Baseplate SystemExactech, Inc.20240—
+4K221968StageOne™ Shoulder Cement Spacer MoldsBiomet, Inc.20220—
+4K191811Catalyst OrthoScience CSR Shoulder SystemCatalyst Orthoscience, Inc.20190—
+4K150583Aequalis PerFORM+ Shoulder SystemTornier, Inc.201516—
+5K173812Catalyst CSR 3 Peg GlenoidsCatalyst Orthoscience, Inc.20181—
+5K160975Aequalis PerFORM+ Shoulder SystemTornier, Inc.20167—
+5K152825Catalyst CSR Shoulder SystemCatalyst Orthoscience, LLC20167—
+6K260721Tornier Perform Advanced GlenoidTornier, Inc.20260—
+6K220847AETOS Shoulder SystemSmith & Nephew, Inc.20235—
+6K182500Catalyst CSR Press-Fit Humeral ComponentsCatalyst Orthoscience, Inc.20192—
+6K181287Catalyst CSR Shoulder SystemCatalyst Orthoscience, Inc.20183—
+6K173964OVOMotion Shoulder Arthroplasty SystemArthrosurface, Inc.20180—
+7K252416AETOS Shoulder System Meta Humeral Prosthesis Size 0Smith & Nephew, Inc.20250—
+7K240716AETOS Shoulder System Stemless Humeral ProsthesisSmith & Nephew, Inc.20243—
+7K230572AETOS Shoulder SystemSmith & Nephew, Inc.20231—
+7K222317Catalyst EA Convertible Stemmed ShoulderCatalyst Orthoscience, Inc.20221—
+8K252418Catalyst F1x Shoulder SystemCatalyst Orthoscience, Inc.20250—
+8K252129AETOS Shoulder System Stemless Humeral ProsthesisSmith & Nephew, Inc.20250—