510(k) Report

Devices descending from K003758

12 later devices reach Allofit Acetabular System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K190660G7 Acetabular System Longevity Highly Crosslinked Polyethylene, G7 Acetabular System…Zimmer, Inc.20194—
+1K103352Versafitcup CC TrioMedacta International20114—
+1K033943Alpha Metasul 28MM and 32MM Acetabular Inserts, Standard and HoodedCenterpulse Orthopedics, Inc.20040—
+1K013935Allofit Acetabular System 32MM Alpha Durasul InsertsSulzer Orthopedics, Inc.20010—
+2K261453G7® Acetabular SystemZimmer Biomet20260—
+2K253948Momentum Acetabular Cup SystemUnited Orthopedic Corporation20260—
+2K251043Mpact 3D Metal Implants Extension – DMLS TechnologyMedacta International S.A.20260—
+2K252067Velora Acetabular SystemRestor3D, Inc.20250—
+2K250450Coated hip implantsMedacta International S.A.20250—
+2K243456ONVOY™ Acetabular SystemGlobus Medical, Inc.20250—
+2K122911Versafitcup CC Trio ExtensionMedacta International20121—
+2K120531Versafitcup CC Trio-Additional LinersMedacta International20122—