510(k) Report

Devices descending from K111065

20 later devices reach Stryker (R) Patient Specific Polymer Implant through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K121315Stryker CMF Medpor Customized ImplantHowmedica Osteonics Corp.20125—
+1K121153Peek Customized Craial Implant KitStryker201213—
+2K182711Customized Craniofacial Implant (CCI), Customized Skull Implant (CSI)Kelyniam Global, Inc.20194—
+2K153248PEEK Customized Cranial ImplantStryker20162—
+2K152076PEEK Customized Cranial Implant, PEEK Customized Cranial Implant PriorityStryker20150—
+2K143173Stryker CMF MEDPOR Customized ImplantStryker20154—
+2K132519Stryker Customized Mandible Recon Plate KitStryker20133—
+3K261058CraniUS PlateCraniUS, LLC20261—
+3K250334Fusion Craniofacial Implant; Fusion Skull ImplantKelyniam Global, Inc.20250—
+3K231834VSP PEEK Cranial Implant3D Systems, Inc.20240—
+3K193136Stryker Customized Mandible Recon Plate KitStryker20201—
+3K190229Stryker PEEK Customized Cranial Implant KitStryker20191—
+3K190696Stryker Surgeon iD Mandible Recon PlateStryker20190—
+3K153508Stryker CMF MEDPOR Customized ImplantStryker20162—
+3K152463SU-POR Patient-Specific Cranial Implant, SU-POR Patient-Specific Facial ImplantPoriferous, LLC20160—
+4K262874CraniUS PlateCraniUS, LLC20260—
+4K222650Stryker Cutomized Mandible Recon Plate; Stryker Surgeon iD Mandible Recon PlateStryker Craniomaxillofacial (Cmf)20220—
+4K203055Stryker PEEK Customized Cranial Implant KitStryker20210—
+4K191916Stryker CMF MEDPOR Priority Customized Implant KitStryker Leibinger GmbH & Co KG20191—
+5K254233MEDPOR Customized Implant KitStryker Leibinger GmbH & Co KG20260—