510(k) Report

Devices descending from K043061

58 later devices reach The Trabecular Metal Glenoid - Bigliani/Flatow the Complete Shoulder Solution… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K060694Modular Hybrid GlenoidBiomet Manufacturing Corp2006574
+2K212933INHANCETM Hybrid Anatomic Glenoid ImplantDepuy Ireland UC20221—
+2K202716Ignite Anatomic Shoulder SystemIgnite Orthopedics, LLC202113—
+2K191814Alliance GlenoidZimmer, Inc.20194—
+2K163397SMR Hybrid Glenoid SystemLima Corporate S.P.A.2017121
+2K093430Exactech Equinoxe XL Keeled Glenoid, Pegged Glenoid, Exactech Equinoxe Cage, Glenoid…Exactech, Inc.2010241
+2K091196GRS Glenoid Resurfacing SystemArthrosurface, Inc.200923—
+3K260721Tornier Perform Advanced GlenoidTornier, Inc.20260—
+3K243248Inhance Intact™Depuy Ireland UC20240—
+3K230831INHANCE Shoulder System Convertible Glenoid Inserts, INHANCE Convertible GlenoidDepuy Ireland UC20230—
+3K223211INHANCETM Shoulder System – Humeral Stems and StemlessDepuy Ireland UC20220—
+3K213785SMR TT Hybrid Glenoid, SMR 3-Pegs Cemented GlenoidLimacorporate20220—
+3K212737INHANCE™ Reverse Shoulder SystemDepuy Ireland UC20229—
+3K203108Ignite Stemless Anatomic Shoulder SystemIgnite Orthopedics, LLC20213—
+3K193180Alliance Augmented GlenoidZimmer, Inc.20203—
+3K190911Physica KR Liner and SMR Reverse Humeral LinerLimacorporate20198—
+3K183042SMR Lateralized Connectors with screwsLima Corporate S.P.A.20190—
+3K172456Bone Screws 6.5mmLima Corporate S.P.A.201812
+3K152825Catalyst CSR Shoulder SystemCatalyst Orthoscience, LLC20167—
+3K113309Exactech Equinoxe Cage GlenoidsExactech, Inc.201138
+3K103419Exactech Equinoxe R Uhmwpe Posterior Augment Pegged Glenoids TMExactech, Inc.2010222
+4K254128InSet Reverse Total Shoulder SystemShoulder Innovations, Inc.20260—
+4K253624INHANCE™ Reverse Shoulder SystemDepuy Ireland UC20260—
+4K250644MSS - Monobloc stemMedacta International S.A.202611
+4K241817InSet Total Shoulder SystemShoulder Innovations, Inc.20251—
+4K233148Augment Off-Axis Instrument SystemFix Surgical20242—
+4K222592AltiVate® Anatomic Shoulder AG e+™ with MarkersEncore Medical L.P.20230—
+4K221467INHANCETM Reverse Glenoid Peripheral PostsDepuy Ireland UC20220—
+4K220792SMR Reverse LinerLima Corporate S.P.A.20227—
+4K212356Exactech® Equinoxe® Laser Cage GlenoidExactech, Inc.202221
+4K182500Catalyst CSR Press-Fit Humeral ComponentsCatalyst Orthoscience, Inc.20192—
+4K181287Catalyst CSR Shoulder SystemCatalyst Orthoscience, Inc.20183—
+4K173964OVOMotion Shoulder Arthroplasty SystemArthrosurface, Inc.20180—
+4K173812Catalyst CSR 3 Peg GlenoidsCatalyst Orthoscience, Inc.20181—
+4K111379Equinoxe Uhmwpe 12* Posterior Augment Pegged Glenoid, Small / Medium / Large /…Exactech, Inc.2011212
+5K262173N22 Offset Humeral HeadShoulder Innovations, Inc.20260—
+5K261016MSS - Humeral reverse liners extensionMedacta International, SA20260—
+5K254084AETOS Shoulder System - CONCELOC GlenoidsSmith & Nephew, Inc.20260—
+5K251184AltiVate Reverse Shoulder System; RSP Shoulder System; SMR Shoulder System; PRIMA…Encore Medical L.P.20250—
+5K241043Augment Off-Axis Instrument SystemFix Surgical202415
+5K231099SMR Hybrid Glenoid SystemLima Corporate S.P.A.20230—
+5K223876SMR Shoulder SystemLima Corporate S.P.A.20233—
+5K222317Catalyst EA Convertible Stemmed ShoulderCatalyst Orthoscience, Inc.20221—
+5K222427PRIMA TT GlenoidLima Corporate S.P.A.202223
+5K191811Catalyst OrthoScience CSR Shoulder SystemCatalyst Orthoscience, Inc.20190—
+5K121220Equinoxe Glenoid, Uhmwpe 16 PS=Osterior Augment Pegged, Small, Left/RightExactech, Inc.2012202
+6K261683Augment Off-Axis Instrument SystemZimmer, Inc.20260—
+6K252418Catalyst F1x Shoulder SystemCatalyst Orthoscience, Inc.20250—
+6K243826SMR Reverse HP Shoulder SystemLima Corporate S.P.A.20251—
+6K233712PRIMA Humeral System; PRIMA TT GlenoidLima Corporate S.P.A.20241—
+6K150583Aequalis PerFORM+ Shoulder SystemTornier, Inc.201516—
+7K252352SMR Shoulder System; PRIMA Glenoid System; PRIMA Humeral SystemLima Corporate S.P.A.20260—
+7K160975Aequalis PerFORM+ Shoulder SystemTornier, Inc.20167—
+8K220847AETOS Shoulder SystemSmith & Nephew, Inc.20235—
+9K252416AETOS Shoulder System Meta Humeral Prosthesis Size 0Smith & Nephew, Inc.20250—
+9K240716AETOS Shoulder System Stemless Humeral ProsthesisSmith & Nephew, Inc.20243—
+9K230572AETOS Shoulder SystemSmith & Nephew, Inc.20231—
+10K252129AETOS Shoulder System Stemless Humeral ProsthesisSmith & Nephew, Inc.20250—