510(k) Report

Devices descending from K062570

17 later devices reach Patient Contoured Mesh (PCM) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K260137KLS Martin IPS Oral-Max Implants - MR Conditional; Individual Patient Solutions - Ti…KLS-Martin L.P.20260—
+1K252573KLS Martin Cranial Implants - MR Conditional; K944565: KLS-Martin Micro Osteosynthesis…KLS-Martin L.P.20250—
+1K161090Cranial PSIOssdsign AB20172—
+1K072707Patient Contoured Mesh-Peek (PCM-P)KLS-Martin L.P.200713—
+2K212414OSSDSIGN Cranial PSIOssdsign AB20210—
+2K190523Cranial PSI Accessory – Anatomical Model Original, Cranial PSI Accessory – Anatomical…Ossdsign AB20190—
+2K151382Patient Contoured Implant-PEEK (PCI-PEEK)KLS Martin L.P.20152—
+2K121755Custom Craniofacial Implant (Cci)Kelyniam Global, Inc.20125—
+2K103582Kelyniam Custom Skull Implant (Csi)Kelyniam Global, Inc.201184
+3K250334Fusion Craniofacial Implant; Fusion Skull ImplantKelyniam Global, Inc.20250—
+3K214109PEEK Patient Specific Cranial/Craniofacial Implant (PSCI)Kontour (Xi’An) Medical Technology Co., Ltd.20220—
+3K182711Customized Craniofacial Implant (CCI), Customized Skull Implant (CSI)Kelyniam Global, Inc.20194—
+3K121818Osteofab Patient Specific Cranial DeviceOxford Performance Materials20131—
+4K261058CraniUS PlateCraniUS, LLC20261—
+4K231834VSP PEEK Cranial Implant3D Systems, Inc.20240—
+4K180064OsteoFab Patient Specific Cranial DeviceOxford Performance Materials, Inc.20180—
+5K262874CraniUS PlateCraniUS, LLC20260—