510(k) Report

Devices descending from K030902

13 later devices reach Palacos R through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K210120BonOs HV, BonOs MV, BonOs LVOsartis GmbH20210—
+1K202475PALACOS R, PALACOS R pro, PALACOS R+G, PALACOS R+G pro, PALACOS MV+GHeraeus Medical GmbH20203—
+1K193061G3 40 Radiopaque Bone CementG21, S.R.L.20200—
+1K193059G1 40 Radiopaque Bone CementG21, S.R.L.20200—
+1K192394Hi-Fatigue Bone CementOsartis GmbH20190—
+1K172408Biomet Bone Cement RBiomet, Inc.20170—
+1K150119PALACOS R proHeraeus Medical GmbH20154—
+1K123225Bonos R 1X20, Bonos R 2X20, Bonos R 1X40, Bonos R 2X40, Bonos R 1X60Aap Biomaterials GmbH & Co. KG20130—
+1K053198Simplex P Speedset Bone CementHowmedica Osteonics Corp.20061—
+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
+2K063857Simplex P Speedset with Tobramycin Bone CementHowmedica Osteonics Corp.20070—
+3K213812PALACOS MV proHeraeus Medical GmbH202202