510(k) Report

Devices descending from K023012

12 later devices reach Smartset HV Bone Cement through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K081155Smartset MV Bone CementDePuy Orthopaedics, Inc.20081—
+1K053445Smartmix Cemvac Pre-Filled with Smartset HV Bone CementDePuy Orthopaedics, Inc.20060—
+1K033563Smartset GHV Gentamicin Bone CementDePuy Orthopaedics, Inc.200491
+2K260536Prostalac Hip System, SmartSet V+G Dual Antibiotic Bone CementDepuy Ireland UC20260—
+2K081163Smartset GMV Gentamicin Bone CementDePuy Orthopaedics, Inc.20080—
+2K061144Depuy CMW 2 and CMW 3 Gentamicin Bone CementDePuy Orthopaedics, Inc.20060—
+2K041656Modification to Depuy 1 Gentamicin Bone Cement and Smartset GMV Endurance Gentamicin…DePuy Orthopaedics, Inc.20048—
+3K053002Depuy CMW 1 Gentamicin Bone CementDePuy Orthopaedics, Inc.20054—
+3K042591Smartmix Pre-Filled Mixing SystemDePuy Orthopaedics, Inc.20041—
+4K173494OrthoSteady G Bone CementG21, S.R.L.20182—
+5K193061G3 40 Radiopaque Bone CementG21, S.R.L.20200—
+5K193059G1 40 Radiopaque Bone CementG21, S.R.L.20200—