510(k) Report

Devices descending from K053199

34 later devices reach Synthes Patient Specific Cranial/Craniofacial Implant through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K250297TECHFIT Patient-Specific Cranial SystemTechfit Digital Surgery, Inc.20250—
+1K220357MedCAD AccuShape Titanium Patient-Specific Cranial ImplantMedcad20222—
+1K182711Customized Craniofacial Implant (CCI), Customized Skull Implant (CSI)Kelyniam Global, Inc.20194—
+1K151692BioArchitects Patient Specific Cranial/Craniofacial PlateBioarchitects USA, LLC20152—
+1K121818Osteofab Patient Specific Cranial DeviceOxford Performance Materials20131—
+1K121755Custom Craniofacial Implant (Cci)Kelyniam Global, Inc.20125—
+1K121153Peek Customized Craial Implant KitStryker201213—
+1K121102Osteosymbionics Peek Cranial ImplantOsteosymbionics, LLC20122—
+1K103582Kelyniam Custom Skull Implant (Csi)Kelyniam Global, Inc.201184
+1K072707Patient Contoured Mesh-Peek (PCM-P)KLS-Martin L.P.200713—
+1K062570Patient Contoured Mesh (PCM)KLS-Martin L.P.200617—
+2K260137KLS Martin IPS Oral-Max Implants - MR Conditional; Individual Patient Solutions - Ti…KLS-Martin L.P.20260—
+2K261058CraniUS PlateCraniUS, LLC20261—
+2K2531163D MAC Titanium Cranial Plate (TCP) SystemThe Surgeon General, Department of the Army (TSG-DA)20260—
+2K252251Easymade-TICG Bio Co., Ltd.20260—
+2K243715Synthes Patient Specific ImplantsSynthes GmbH20250—
+2K252573KLS Martin Cranial Implants - MR Conditional; K944565: KLS-Martin Micro Osteosynthesis…KLS-Martin L.P.20250—
+2K250334Fusion Craniofacial Implant; Fusion Skull ImplantKelyniam Global, Inc.20250—
+2K231834VSP PEEK Cranial Implant3D Systems, Inc.20240—
+2K180064OsteoFab Patient Specific Cranial DeviceOxford Performance Materials, Inc.20180—
+2K161090Cranial PSIOssdsign AB20172—
+2K153248PEEK Customized Cranial ImplantStryker20162—
+2K151382Patient Contoured Implant-PEEK (PCI-PEEK)KLS Martin L.P.20152—
+2K152076PEEK Customized Cranial Implant, PEEK Customized Cranial Implant PriorityStryker20150—
+2K132519Stryker Customized Mandible Recon Plate KitStryker20133—
+3K262874CraniUS PlateCraniUS, LLC20260—
+3K214109PEEK Patient Specific Cranial/Craniofacial Implant (PSCI)Kontour (Xi’An) Medical Technology Co., Ltd.20220—
+3K212414OSSDSIGN Cranial PSIOssdsign AB20210—
+3K193136Stryker Customized Mandible Recon Plate KitStryker20201—
+3K190523Cranial PSI Accessory – Anatomical Model Original, Cranial PSI Accessory – Anatomical…Ossdsign AB20190—
+3K190229Stryker PEEK Customized Cranial Implant KitStryker20191—
+3K190696Stryker Surgeon iD Mandible Recon PlateStryker20190—
+4K222650Stryker Cutomized Mandible Recon Plate; Stryker Surgeon iD Mandible Recon PlateStryker Craniomaxillofacial (Cmf)20220—
+4K203055Stryker PEEK Customized Cranial Implant KitStryker20210—