510(k) Report

Devices descending from K031673

15 later devices reach Refobacin -Palacos G through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K210125BonOs HV Genta, BonOs MV Genta, BonOs LV GentaOsartis GmbH20210—
+1K202475PALACOS R, PALACOS R pro, PALACOS R+G, PALACOS R+G pro, PALACOS MV+GHeraeus Medical GmbH20203—
+1K192379Hi-Fatigue G Bone CementOsartis GmbH20190—
+1K190766PALACOS fast R+GHeraeus Medical GmbH20190—
+1K173494OrthoSteady G Bone CementG21, S.R.L.20182—
+1K171540Refobacin Bone Cement RBiomet, Inc.20171—
+1K150850Refobacin Bone Cement RBiomet, Inc.20150—
+1K142157Palacos R+G ProHeraeus Medical GmbH20144—
+1K123081Bonos R Genta 1X20 Model 01-0228; Bonos R Genta 2X20 Model 01-0229; Bonos R Genta 1X40…Aap Biomaterials GmbH & Co. KG201301
+2K254107Refobacin Bone Cement R (110034355)Biomet France20260—
+2K211869OGM 1 Polymethylmethacrylate (PMMA) bone cement, OGM 1A Polymethylmethacrylate (PMMA)…Ormed Grup Medikal Turizm Saglik Hizmetleri Sanayi VE20220—
+2K210607PALACOS R pro, PALACOS R+G pro, PALACOS MV+G proHeraeus Medical GmbH202116
+2K193061G3 40 Radiopaque Bone CementG21, S.R.L.20200—
+2K193059G1 40 Radiopaque Bone CementG21, S.R.L.20200—
+3K213812PALACOS MV proHeraeus Medical GmbH202202