510(k) Report

Devices descending from K150583

16 later devices reach Aequalis PerFORM+ Shoulder System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K173812Catalyst CSR 3 Peg GlenoidsCatalyst Orthoscience, Inc.20181—
+1K160975Aequalis PerFORM+ Shoulder SystemTornier, Inc.20167—
+1K152825Catalyst CSR Shoulder SystemCatalyst Orthoscience, LLC20167—
+2K260721Tornier Perform Advanced GlenoidTornier, Inc.20260—
+2K220847AETOS Shoulder SystemSmith & Nephew, Inc.20235—
+2K191811Catalyst OrthoScience CSR Shoulder SystemCatalyst Orthoscience, Inc.20190—
+2K182500Catalyst CSR Press-Fit Humeral ComponentsCatalyst Orthoscience, Inc.20192—
+2K181287Catalyst CSR Shoulder SystemCatalyst Orthoscience, Inc.20183—
+2K173964OVOMotion Shoulder Arthroplasty SystemArthrosurface, Inc.20180—
+3K254084AETOS Shoulder System - CONCELOC GlenoidsSmith & Nephew, Inc.20260—
+3K252416AETOS Shoulder System Meta Humeral Prosthesis Size 0Smith & Nephew, Inc.20250—
+3K240716AETOS Shoulder System Stemless Humeral ProsthesisSmith & Nephew, Inc.20243—
+3K230572AETOS Shoulder SystemSmith & Nephew, Inc.20231—
+3K222317Catalyst EA Convertible Stemmed ShoulderCatalyst Orthoscience, Inc.20221—
+4K252418Catalyst F1x Shoulder SystemCatalyst Orthoscience, Inc.20250—
+4K252129AETOS Shoulder System Stemless Humeral ProsthesisSmith & Nephew, Inc.20250—