510(k) Report

Devices descending from K033944

8 later devices reach Stelkast 32MM Modular Ceramic Femoral Head through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K132158Novohip Total Hip SystemNovosource, Inc.201461
+1K100008Cardo Medical Ceramic Hip SystemCardo Medical, Inc.20100—
+2K213842ONVOY Acetabular SystemGlobus Medical, Inc.20221—
+2K143314Progressive Orthopaedic Total Hip SystemThe Progressive Orthopaedic Company, LLC20152—
+2K140701Novohip Bipolar Head/Novohip Vitamin E Liner/ Bone Screws/ Hole PlugNovosource, Inc.20142—
+3K243456ONVOY™ Acetabular SystemGlobus Medical, Inc.20250—
+3K192450Precision Casting Solutions Total Hip SystemPrecision Casting Solution, LLC20190—
+3K151424The Progressive Orthopaedic Total Hip SystemThe Progressive Orthopaedic Company, LLC20161—