510(k) Report

Devices descending from K072707

13 later devices reach Patient Contoured Mesh-Peek (PCM-P) 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—
+1K151382Patient Contoured Implant-PEEK (PCI-PEEK)KLS Martin L.P.20152—
+1K121755Custom Craniofacial Implant (Cci)Kelyniam Global, Inc.20125—
+1K103582Kelyniam Custom Skull Implant (Csi)Kelyniam Global, Inc.201184
+2K250334Fusion Craniofacial Implant; Fusion Skull ImplantKelyniam Global, Inc.20250—
+2K214109PEEK Patient Specific Cranial/Craniofacial Implant (PSCI)Kontour (Xi’An) Medical Technology Co., Ltd.20220—
+2K182711Customized Craniofacial Implant (CCI), Customized Skull Implant (CSI)Kelyniam Global, Inc.20194—
+2K121818Osteofab Patient Specific Cranial DeviceOxford Performance Materials20131—
+3K261058CraniUS PlateCraniUS, LLC20261—
+3K231834VSP PEEK Cranial Implant3D Systems, Inc.20240—
+3K180064OsteoFab Patient Specific Cranial DeviceOxford Performance Materials, Inc.20180—
+4K262874CraniUS PlateCraniUS, LLC20260—