510(k) Report

Devices descending from K072601

20 later devices reach Osteosymbionics Patient Specific Cranial Implant through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K170410Longeviti PMMA Static Cranial ImplantLongeviti Neuro Solutions, LLC20184—
+1K133082Osteosymbionics Patient-Specific Cranial PlateOsteosymbionics, LLC20145—
+1K121818Osteofab Patient Specific Cranial DeviceOxford Performance Materials20131—
+1K121102Osteosymbionics Peek Cranial ImplantOsteosymbionics, LLC20122—
+1K110684Medcad Accushape (TM) Peek Patient Specific Cranial / Craniofacial ImplantVanduzen Dba Medcad201111—
+1K103582Kelyniam Custom Skull Implant (Csi)Kelyniam Global, Inc.201184
+2K250334Fusion Craniofacial Implant; Fusion Skull ImplantKelyniam Global, Inc.20250—
+2K220357MedCAD AccuShape Titanium Patient-Specific Cranial ImplantMedcad20222—
+2K191210Longeviti ClearFit Cranial ImplantLongeviti Neuro Solutions, LLC20203—
+2K182711Customized Craniofacial Implant (CCI), Customized Skull Implant (CSI)Kelyniam Global, Inc.20194—
+2K180064OsteoFab Patient Specific Cranial DeviceOxford Performance Materials, Inc.20180—
+2K121755Custom Craniofacial Implant (Cci)Kelyniam Global, Inc.20125—
+3K261058CraniUS PlateCraniUS, LLC20261—
+3K252251Easymade-TICG Bio Co., Ltd.20260—
+3K243715Synthes Patient Specific ImplantsSynthes GmbH20250—
+3K231834VSP PEEK Cranial Implant3D Systems, Inc.20240—
+3K203349Longeviti ClearFit Cranial ImplantLongeviti Neuro Solutions, LLC20202—
+4K262874CraniUS PlateCraniUS, LLC20260—
+4K231920Longeviti ClearFit OTS Cranial ImplantLongeviti Neuro Solutions, LLC20231—
+5K260709ClearFit Ti Ring 14mm (171750);ClearFit Ti Ring 14mm with Slot (171751);ClearFit Ti Ring…Longeviti Neuro Solutions20260—