510(k) Report

Devices descending from K033868

44 later devices reach Synthes (Usa) Patient Specific Cranial/Craniofacial Implants through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K121102Osteosymbionics Peek Cranial ImplantOsteosymbionics, LLC20122—
+1K110684Medcad Accushape (TM) Peek Patient Specific Cranial / Craniofacial ImplantVanduzen Dba Medcad201111—
+1K072707Patient Contoured Mesh-Peek (PCM-P)KLS-Martin L.P.200713—
+1K072601Osteosymbionics Patient Specific Cranial ImplantOsteosymbionics, LLC200720—
+1K062570Patient Contoured Mesh (PCM)KLS-Martin L.P.200617—
+1K052871Stryker Custom TI ImplantStryker Leibinger200518—
+1K053199Synthes Patient Specific Cranial/Craniofacial ImplantSynthes (Usa)200534—
+2K260137KLS Martin IPS Oral-Max Implants - MR Conditional; Individual Patient Solutions - Ti…KLS-Martin L.P.20260—
+2K252573KLS Martin Cranial Implants - MR Conditional; K944565: KLS-Martin Micro Osteosynthesis…KLS-Martin L.P.20250—
+2K250297TECHFIT Patient-Specific Cranial SystemTechfit Digital Surgery, Inc.20250—
+2K220357MedCAD AccuShape Titanium Patient-Specific Cranial ImplantMedcad20222—
+2K182711Customized Craniofacial Implant (CCI), Customized Skull Implant (CSI)Kelyniam Global, Inc.20194—
+2K170410Longeviti PMMA Static Cranial ImplantLongeviti Neuro Solutions, LLC20184—
+2K161090Cranial PSIOssdsign AB20172—
+2K151692BioArchitects Patient Specific Cranial/Craniofacial PlateBioarchitects USA, LLC20152—
+2K151382Patient Contoured Implant-PEEK (PCI-PEEK)KLS Martin L.P.20152—
+2K133082Osteosymbionics Patient-Specific Cranial PlateOsteosymbionics, LLC20145—
+2K121818Osteofab Patient Specific Cranial DeviceOxford Performance Materials20131—
+2K121755Custom Craniofacial Implant (Cci)Kelyniam Global, Inc.20125—
+2K121153Peek Customized Craial Implant KitStryker201213—
+2K103582Kelyniam Custom Skull Implant (Csi)Kelyniam Global, Inc.201184
+3K261058CraniUS PlateCraniUS, LLC20261—
+3K2531163D MAC Titanium Cranial Plate (TCP) SystemThe Surgeon General, Department of the Army (TSG-DA)20260—
+3K252251Easymade-TICG Bio Co., Ltd.20260—
+3K243715Synthes Patient Specific ImplantsSynthes GmbH20250—
+3K250334Fusion Craniofacial Implant; Fusion Skull ImplantKelyniam Global, Inc.20250—
+3K231834VSP PEEK Cranial Implant3D Systems, Inc.20240—
+3K214109PEEK Patient Specific Cranial/Craniofacial Implant (PSCI)Kontour (Xi’An) Medical Technology Co., Ltd.20220—
+3K212414OSSDSIGN Cranial PSIOssdsign AB20210—
+3K191210Longeviti ClearFit Cranial ImplantLongeviti Neuro Solutions, LLC20203—
+3K190523Cranial PSI Accessory – Anatomical Model Original, Cranial PSI Accessory – Anatomical…Ossdsign AB20190—
+3K180064OsteoFab Patient Specific Cranial DeviceOxford Performance Materials, Inc.20180—
+3K153248PEEK Customized Cranial ImplantStryker20162—
+3K152076PEEK Customized Cranial Implant, PEEK Customized Cranial Implant PriorityStryker20150—
+3K132519Stryker Customized Mandible Recon Plate KitStryker20133—
+4K262874CraniUS PlateCraniUS, LLC20260—
+4K203349Longeviti ClearFit Cranial ImplantLongeviti Neuro Solutions, LLC20202—
+4K193136Stryker Customized Mandible Recon Plate KitStryker20201—
+4K190229Stryker PEEK Customized Cranial Implant KitStryker20191—
+4K190696Stryker Surgeon iD Mandible Recon PlateStryker20190—
+5K231920Longeviti ClearFit OTS Cranial ImplantLongeviti Neuro Solutions, LLC20231—
+5K222650Stryker Cutomized Mandible Recon Plate; Stryker Surgeon iD Mandible Recon PlateStryker Craniomaxillofacial (Cmf)20220—
+5K203055Stryker PEEK Customized Cranial Implant KitStryker20210—
+6K260709ClearFit Ti Ring 14mm (171750);ClearFit Ti Ring 14mm with Slot (171751);ClearFit Ti Ring…Longeviti Neuro Solutions20260—