510(k) Report

Devices descending from K960906

86 later devices reach Foundation Glenoid Component through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K130642SMR 3-Pegs GlenoidsLima Corporate S.P.A.201314—
+1K042021Exactech Equinoxe Shoulder SystemExactech, Inc.20047110
+2K173388Exactech Equinoxe Stemless ShoulderExactech, Inc.20189—
+2K163397SMR Hybrid Glenoid SystemLima Corporate S.P.A.2017121
+2K162726Exactech® Equinoxe® Preserve StemExactech, Inc.201731
+2K153722SMR 3-Pegs GlenoidsLima Corporate S.P.A.201613—
+2K150568ARROW Humeral stems size 6 and 16Fournitures Hospitalieres Industrie20154—
+2K140063Equinoxe Extra Short Humeral HeadExactech, Inc.201410—
+2K121067Exactech Equinoxe Shoulder System Torque Defining Screw and Short Replicator PlateExactech, Inc.20120—
+2K113309Exactech Equinoxe Cage GlenoidsExactech, Inc.201138
+2K110706Exactech Equinoxe Cuff Tear Arthroplasty (Cta) HeadExactech, Inc.20110—
+2K103419Exactech Equinoxe R Uhmwpe Posterior Augment Pegged Glenoids TMExactech, Inc.2010222
+2K093599Arrow Anatomical Shoulder SystemFournitures Hospitalieres Industrie201011—
+2K102951Exactech Equinox Fixed Angle Replicator Plate (0MM,1.5MM,4.5MM), Humeral Head-Short…Exactech, Inc.201072
+2K093430Exactech Equinoxe XL Keeled Glenoid, Pegged Glenoid, Exactech Equinoxe Cage, Glenoid…Exactech, Inc.2010241
+2K092900Exactech Equinoxe Platform Fracture Stem and Revision Platform Fracture StemExactech, Inc.201022
+2K061454Exactech Equinoxe Shoulder StemsExactech, Inc.200616—
+2K060535Spacer-S Temporary Shoulder SpacerTecres S.P.A.20068—
+3K250713Equinoxe® Humeral Reconstruction Prosthesis; Equinoxe® Stemless Shoulder ImplantsExactech, Inc.20250—
+3K253345JARVIS Diaphyseal Stem StandardFH Industrie20251—
+3K232226ARROW Off-Centred Humeral InsertFH Industrie20230—
+3K222592AltiVate® Anatomic Shoulder AG e+™ with MarkersEncore Medical L.P.20230—
+3K213785SMR TT Hybrid Glenoid, SMR 3-Pegs Cemented GlenoidLimacorporate20220—
+3K212356Exactech® Equinoxe® Laser Cage GlenoidExactech, Inc.202221
+3K202024ARROW Short Stem Humeral SystemFH Industrie20212—
+3K203108Ignite Stemless Anatomic Shoulder SystemIgnite Orthopedics, LLC20213—
+3K192097Exactech® Equinoxe® Stemless Humeral ComponentsExactech, Inc.20201—
+3K190911Physica KR Liner and SMR Reverse Humeral LinerLimacorporate20198—
+3K182516Comprehensive Nano Stemless ShoulderBiomet Manufacturing Corp20196—
+3K183042SMR Lateralized Connectors with screwsLima Corporate S.P.A.20190—
+3K180632Exactech Equinoxe Small Reverse Shoulder SystemExactech, Inc.201853
+3K172456Bone Screws 6.5mmLima Corporate S.P.A.201812
+3K162068ARROW Anatomical Porous glenoidFournitures Hospitalieres Industrie20174—
+3K152267Remedy® Shoulder SpacerOsteoremedies, LLC20152—
+3K131277Seviin Fracture ShoulderIngen Orthopedics, LLC20130—
+3K112193Arrow Reverse Shoulder SystemFournitures Hospitalieres Industrie201210—
+3K112983Spacer-STecres S.P.A.20117—
+3K111379Equinoxe Uhmwpe 12* Posterior Augment Pegged Glenoid, Small / Medium / Large /…Exactech, Inc.2011212
+3K101909Exactech Equinoxe, Platform Fracture StemExactech, Inc.201004
+4K254084AETOS Shoulder System - CONCELOC GlenoidsSmith & Nephew, Inc.20260—
+4K254003JARVIS Metaphyseal StemFH Industrie20260—
+4K252443SpaceFix Shoulder SpacerG21, S.R.L.20250—
+4K243248Inhance Intact™Depuy Ireland UC20240—
+4K241873OsseoFit Stemless Shoulder SystemZimmer, Inc.20241—
+4K242253JARVIS Glenoid Reverse Shoulder ProsthesisFH Industrie20241—
+4K240856Hip Spacer Molds; Knee Spacer Molds; Shoulder Spacer MoldsOsartis GmbH20240—
+4K231099SMR Hybrid Glenoid SystemLima Corporate S.P.A.20230—
+4K230831INHANCE Shoulder System Convertible Glenoid Inserts, INHANCE Convertible GlenoidDepuy Ireland UC20230—
+4K223833Exactech® Equinoxe® Reverse Humeral Liners and Humeral Adapter TraysExactech, Inc.202321
+4K223211INHANCETM Shoulder System – Humeral Stems and StemlessDepuy Ireland UC20220—
+4K220792SMR Reverse LinerLima Corporate S.P.A.20227—
+4K202338SpaceFlex ShoulderG21, S.R.L.20211—
+4K182536Exactech Equinoxe Small Reverse Shoulder Glenospheres , Exactech Equinoxe Reverse…Exactech, Inc.201843
+4K171789ARROW Reverse Porous GlenoidFournitures Hospitalieres Industrie20183—
+4K160071StageOne Disposable Cement Spacer Molds for Temporary Hemi-Shoulder ProsthesisBiomet, Inc.201635
+4K142778ARROW Reverse Shoulder long keel and short keel glenoid baseFournitures Hospitalieres Industrie20155—
+4K131135Biomet Stage One Disposable Cement Spacer Molds for Temporary Hemi-Shoulder ProsthesisBiomet Manufacturing Corp201445
+4K121220Equinoxe Glenoid, Uhmwpe 16 PS=Osterior Augment Pegged, Small, Left/RightExactech, Inc.2012202
+5K262955OsseoFit Stemless Shoulder SystemZimmer, Inc.20260—
+5K260583Equinoxe® Shoulder SystemExactech, Inc.20260—
+5K252411JARVIS Glenoid Reverse Shoulder ProsthesisFH Industrie20250—
+5K243448Equinoxe® Shoulder SystemExactech, Inc.20250—
+5K251184AltiVate Reverse Shoulder System; RSP Shoulder System; SMR Shoulder System; PRIMA…Encore Medical L.P.20250—
+5K233482Equinoxe® Central Screw Baseplate SystemExactech, Inc.20240—
+5K223876SMR Shoulder SystemLima Corporate S.P.A.20233—
+5K222427PRIMA TT GlenoidLima Corporate S.P.A.202223
+5K221968StageOne™ Shoulder Cement Spacer MoldsBiomet, Inc.20220—
+5K191811Catalyst OrthoScience CSR Shoulder SystemCatalyst Orthoscience, Inc.20190—
+5K150583Aequalis PerFORM+ Shoulder SystemTornier, Inc.201516—
+6K243826SMR Reverse HP Shoulder SystemLima Corporate S.P.A.20251—
+6K233712PRIMA Humeral System; PRIMA TT GlenoidLima Corporate S.P.A.20241—
+6K173812Catalyst CSR 3 Peg GlenoidsCatalyst Orthoscience, Inc.20181—
+6K160975Aequalis PerFORM+ Shoulder SystemTornier, Inc.20167—
+6K152825Catalyst CSR Shoulder SystemCatalyst Orthoscience, LLC20167—
+7K260721Tornier Perform Advanced GlenoidTornier, Inc.20260—
+7K252352SMR Shoulder System; PRIMA Glenoid System; PRIMA Humeral SystemLima Corporate S.P.A.20260—
+7K220847AETOS Shoulder SystemSmith & Nephew, Inc.20235—
+7K182500Catalyst CSR Press-Fit Humeral ComponentsCatalyst Orthoscience, Inc.20192—
+7K181287Catalyst CSR Shoulder SystemCatalyst Orthoscience, Inc.20183—
+7K173964OVOMotion Shoulder Arthroplasty SystemArthrosurface, Inc.20180—
+8K252416AETOS Shoulder System Meta Humeral Prosthesis Size 0Smith & Nephew, Inc.20250—
+8K240716AETOS Shoulder System Stemless Humeral ProsthesisSmith & Nephew, Inc.20243—
+8K230572AETOS Shoulder SystemSmith & Nephew, Inc.20231—
+8K222317Catalyst EA Convertible Stemmed ShoulderCatalyst Orthoscience, Inc.20221—
+9K252418Catalyst F1x Shoulder SystemCatalyst Orthoscience, Inc.20250—
+9K252129AETOS Shoulder System Stemless Humeral ProsthesisSmith & Nephew, Inc.20250—