510(k) Report

Devices descending from K041656

8 later devices reach Modification to Depuy 1 Gentamicin Bone Cement and Smartset GMV Endurance… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K081163Smartset GMV Gentamicin Bone CementDePuy Orthopaedics, Inc.20080—
+1K061144Depuy CMW 2 and CMW 3 Gentamicin Bone CementDePuy Orthopaedics, Inc.20060—
+1K053002Depuy CMW 1 Gentamicin Bone CementDePuy Orthopaedics, Inc.20054—
+1K042591Smartmix Pre-Filled Mixing SystemDePuy Orthopaedics, Inc.20041—
+2K173494OrthoSteady G Bone CementG21, S.R.L.20182—
+2K053445Smartmix Cemvac Pre-Filled with Smartset HV Bone CementDePuy Orthopaedics, Inc.20060—
+3K193061G3 40 Radiopaque Bone CementG21, S.R.L.20200—
+3K193059G1 40 Radiopaque Bone CementG21, S.R.L.20200—