510(k) Report

Devices descending from K110708

30 later devices reach Equinoxe Reverse Shoulder Compression Screw / 38MM and 42MM Glenosphere /… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K193098Exactech® Equinoxe® Reverse Shoulder GlenospheresExactech, Inc.20200—
+1K180632Exactech Equinoxe Small Reverse Shoulder SystemExactech, Inc.201853
+1K172502Comprehensive Augmented Glenoid Components, Comprehensive Standard Baseplate…Biomet Manufacturing Corp2018201
+1K162325Exactech Equinoxe Reverse Shoulder Locking Cap, Exactech Equinoxe Reverse Shoulder…Exactech, Inc.20170—
+1K131575Exactech Equinox Superior/Posterior Augment Reverse Shoulder Glenoid Baseplate - Left &…Exactech, Inc.20136—
+2K252404Comprehensive Reverse Shoulder - HA Glenosphere BaseplatesBiomet Orthopedics20260—
+2K231445LINK Embrace Shoulder System - Reverse ConfigurationWaldemar Link GmbH & Co. KG20230—
+2K223833Exactech® Equinoxe® Reverse Humeral Liners and Humeral Adapter TraysExactech, Inc.202321
+2K214001Comprehensive® Shoulder System, Comprehensive® Reverse Shoulder SystemBiomet Manufacturing Corp20231—
+2K210533Inset Reverse Total Shoulder SystemShoulder Innovations, Inc.20213—
+2K200171SMR TT Augmented Glenoid SystemLima Corporate S.P.A.202011—
+2K191746SMR TT Augmented Glenoid SystemLima Corporate S.P.A.201912—
+2K182536Exactech Equinoxe Small Reverse Shoulder Glenospheres , Exactech Equinoxe Reverse…Exactech, Inc.201843
+3K260583Equinoxe® Shoulder SystemExactech, Inc.20260—
+3K252516N22 EZ GlenosphereShoulder Innovations, Inc.20260—
+3K252221Inset Reverse Total Shoulder SystemShoulder Innovations, Inc.20251—
+3K243448Equinoxe® Shoulder SystemExactech, Inc.20250—
+3K233482Equinoxe® Central Screw Baseplate SystemExactech, Inc.20240—
+3K230572AETOS Shoulder SystemSmith & Nephew, Inc.20231—
+3K210717Bone Screws dia. 5,0 mmLima Corporate S.P.A.20218—
+4K254128InSet Reverse Total Shoulder SystemShoulder Innovations, Inc.20260—
+4K252416AETOS Shoulder System Meta Humeral Prosthesis Size 0Smith & Nephew, Inc.20250—
+4K220792SMR Reverse LinerLima Corporate S.P.A.20227—
+5K251184AltiVate Reverse Shoulder System; RSP Shoulder System; SMR Shoulder System; PRIMA…Encore Medical L.P.20250—
+5K223876SMR Shoulder SystemLima Corporate S.P.A.20233—
+5K222427PRIMA TT GlenoidLima Corporate S.P.A.202223
+6K243826SMR Reverse HP Shoulder SystemLima Corporate S.P.A.20251—
+6K233712PRIMA Humeral System; PRIMA TT GlenoidLima Corporate S.P.A.20241—
+6K231099SMR Hybrid Glenoid SystemLima Corporate S.P.A.20230—
+7K252352SMR Shoulder System; PRIMA Glenoid System; PRIMA Humeral SystemLima Corporate S.P.A.20260—