510(k) Report

Devices descending from K010352

13 later devices reach CPS 1.5/2.0/2.5 Bioabsorbable Fixation System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K251441Inion CPS 1.5 Baby Bioabsorbable Fixation System; Inion CPS 1.5/2.0/2.5 Bioabsorbable…Inion OY20250—
+1K251472Inion CPS 1.5/2.0/2.5 Bioabsorbable Fixation System; Inion CPS 1.5 Baby Bioabsorbable…Inion OY20250—
+1K122890Inion CPS Orbital PlatesInion OY20131—
+1K073006Osteotrans -MX Bioabsorbable Bone Fixation SystemTakiron Co., Ltd.20082—
+1K061881Osteotrans -MX Bioabsorbable Bone Fixation SystemTakiron Co., Ltd.20073—
+1K063410Inion CPS/Otps FreedomplateInion, Ltd.20072—
+1K022981Inion CPS 2.5/2.8 ScrewInion, Ltd.20021—
+1K020266Inion CPS Bsso ScrewInion, Ltd.200213
+1K013039Inion CPS 2.0 Orthognathic PlateInion, Ltd.20011—
+2K121606Resorb-X GKLS-Martin L.P.20130—
+2K101835Medpor Fixation System-Cranial, Models 80080, 80079Porex Surgical, Inc.20100—
+2K081588RE-Zorb Plating SystemAcute Innovations, LLC20081—
+3K120163Acute Innovations Biobridge Resorbable Plating SystemAcute Innovations, LLC20120—