510(k) Report

Devices descending from P960001

22 later devices reach Depuy 1 Bone Cement through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K081155Smartset MV Bone CementDePuy Orthopaedics, Inc.20081—
+1K053003Depuy CMW 1, 2 and 3 Bone CementsDePuy Orthopaedics, Inc.20052—
+1K042591Smartmix Pre-Filled Mixing SystemDePuy Orthopaedics, Inc.20041—
+1K033382Smartset GMV Endurance Gentamicin Bone CementDePuy Orthopaedics, Inc.200416—
+1K023012Smartset HV Bone CementDePuy Orthopaedics, Inc.200312—
+1K021499Cemvac Ultra Pre-Packed with Depuy 1 Bone CementDePuy Orthopaedics, Inc.20022—
+2K260536Prostalac Hip System, SmartSet V+G Dual Antibiotic Bone CementDepuy Ireland UC20260—
+2K212729Bone Cement-Normal ViscosityBiomecanica Industria E Comerciode Produtos Ortopedicos Ltda20220—
+2K071927Modification to Vertebroplastic Radiopaque Bone CementDepuy Spine, A Johnson & Johnson Company20072—
+2K071791Modification to Cranioplastic, Model 43-1280Codman & Shurtleff, Inc.20070—
+2K071776Aneuroplastic, Model 43-1290Codman & Shurtleff, Inc.20070—
+2K061144Depuy CMW 2 and CMW 3 Gentamicin Bone CementDePuy Orthopaedics, Inc.20060—
+2K053445Smartmix Cemvac Pre-Filled with Smartset HV Bone CementDePuy Orthopaedics, Inc.20060—
+2K053002Depuy CMW 1 Gentamicin Bone CementDePuy Orthopaedics, Inc.20054—
+2K041656Modification to Depuy 1 Gentamicin Bone Cement and Smartset GMV Endurance Gentamicin…DePuy Orthopaedics, Inc.20048—
+2K033563Smartset GHV Gentamicin Bone CementDePuy Orthopaedics, Inc.200491
+3K201831CONFIDENCE Spinal Cement SystemDepuy Spine, Inc.20200—
+3K173494OrthoSteady G Bone CementG21, S.R.L.20182—
+3K112907Confidence High Viscosity Spinal Cement, 16G / 20GMedos International SARL20110—
+3K081163Smartset GMV Gentamicin Bone CementDePuy Orthopaedics, Inc.20080—
+4K193061G3 40 Radiopaque Bone CementG21, S.R.L.20200—
+4K193059G1 40 Radiopaque Bone CementG21, S.R.L.20200—