510(k) Report

Devices descending from K990136

135 later devices reach Anatomica Glenoid Component through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K221968StageOne™ Shoulder Cement Spacer MoldsBiomet, Inc.20220—
+5K213785SMR TT Hybrid Glenoid, SMR 3-Pegs Cemented GlenoidLimacorporate20220—
+5K212800PRIMA Humeral System and SMR Glenosphere Ø42Lima Corporate S.P.A.202222
+5K211729Comprehensive® Convertible Glenoid - Vivacit-E LinerBiomet Manufacturing Corp20212—
+5K210717Bone Screws dia. 5,0 mmLima Corporate S.P.A.20218—
+5K190911Physica KR Liner and SMR Reverse Humeral LinerLimacorporate20198—
+5K191746SMR TT Augmented Glenoid SystemLima Corporate S.P.A.201912—
+5K191811Catalyst OrthoScience CSR Shoulder SystemCatalyst Orthoscience, Inc.20190—
+5K161120SMR TT Metal Back Glenoid, Bone Graft instrumentsLima Corporate S.P.A.20172—
+5K161189Integra TITAN Reverse Shoulder SystemIntegra LifeSciences Corporation20168—
+5K150583Aequalis PerFORM+ Shoulder SystemTornier, Inc.201516—
+5K132435Smith & Nephew Global Femoral Head TrialsSmith & Nephew, Inc.20130—
+5K113523Limacorporate SMR Reverse Shoulder SystemLima Corporate S.P.A.201110—
+6K252129AETOS Shoulder System Stemless Humeral ProsthesisSmith & Nephew, Inc.20250—
+6K234105Catalyst F1x Shoulder SystemCatalyst Orthoscience, Inc.20240—
+6K233712PRIMA Humeral System; PRIMA TT GlenoidLima Corporate S.P.A.20241—
+6K214001Comprehensive® Shoulder System, Comprehensive® Reverse Shoulder SystemBiomet Manufacturing Corp20231—
+6K220792SMR Reverse LinerLima Corporate S.P.A.20227—
+6K190588Integra TITAN Reverse Shoulder SystemIntegra LifeSciences Corporation20194—
+6K173717Integra TITAN Reverse Shoulder SystemIntegra LifeSciences Corporation20183—
+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—
+7K252404Comprehensive Reverse Shoulder - HA Glenosphere BaseplatesBiomet Orthopedics20260—
+7K223876SMR Shoulder SystemLima Corporate S.P.A.20233—
+7K222427PRIMA TT GlenoidLima Corporate S.P.A.202223
+7K182500Catalyst CSR Press-Fit Humeral ComponentsCatalyst Orthoscience, Inc.20192—
+7K181999Integra TITAN Reverse Shoulder SystemIntegra LifeSciences Corporation20182—
+7K181287Catalyst CSR Shoulder SystemCatalyst Orthoscience, Inc.20183—
+7K173964OVOMotion Shoulder Arthroplasty SystemArthrosurface, Inc.20180—
+8K243826SMR Reverse HP Shoulder SystemLima Corporate S.P.A.20251—
+8K222317Catalyst EA Convertible Stemmed ShoulderCatalyst Orthoscience, Inc.20221—
+9K252352SMR Shoulder System; PRIMA Glenoid System; PRIMA Humeral SystemLima Corporate S.P.A.20260—
+9K252418Catalyst F1x Shoulder SystemCatalyst Orthoscience, Inc.20250—