510(k) Report

Devices descending from K992394

12 later devices reach Buechel-Pappas Humeral Head Resurfacing Component through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K193122Biocore9 Humeral Resurfacing SystemBiocore9, LLC20200—
+1K023096Contoured Articular Prosthesis (Cap) Humeral Head Resurfacing SystemStd Mfg., Inc.2003105
+2K152825Catalyst CSR Shoulder SystemCatalyst Orthoscience, LLC20167—
+2K142942HemiCAP Humeral Head XL (HHXL) Articular Resurfacing SystemArthrosurface, Inc.20141—
+2K131298Exactech Equinoxe Resurfacing Humeral Head SystemExactech, Inc.20138—
+3K182500Catalyst CSR Press-Fit Humeral ComponentsCatalyst Orthoscience, Inc.20192—
+3K181287Catalyst CSR Shoulder SystemCatalyst Orthoscience, Inc.20183—
+3K173964OVOMotion Shoulder Arthroplasty SystemArthrosurface, Inc.20180—
+3K173812Catalyst CSR 3 Peg GlenoidsCatalyst Orthoscience, Inc.20181—
+4K222317Catalyst EA Convertible Stemmed ShoulderCatalyst Orthoscience, Inc.20221—
+4K191811Catalyst OrthoScience CSR Shoulder SystemCatalyst Orthoscience, Inc.20190—
+5K252418Catalyst F1x Shoulder SystemCatalyst Orthoscience, Inc.20250—