510(k) Report

Devices descending from K103010

23 later devices reach Stryker Patient Specific Polymer Implant through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K133809Osteofab Patient Specific Facial DeviceOxford Performance Materials20141—
+1K121315Stryker CMF Medpor Customized ImplantHowmedica Osteonics Corp.20125—
+1K111065Stryker (R) Patient Specific Polymer ImplantHowmedica Osteonics Corp. Dba Stryker Orthopeadics201120—
+2K161052OsteoFab Patient Specific Facial DeviceOxford Performance Materials, Inc.20160—
+2K143173Stryker CMF MEDPOR Customized ImplantStryker20154—
+2K121153Peek Customized Craial Implant KitStryker201213—
+3K182711Customized Craniofacial Implant (CCI), Customized Skull Implant (CSI)Kelyniam Global, Inc.20194—
+3K153248PEEK Customized Cranial ImplantStryker20162—
+3K153508Stryker CMF MEDPOR Customized ImplantStryker20162—
+3K152463SU-POR Patient-Specific Cranial Implant, SU-POR Patient-Specific Facial ImplantPoriferous, LLC20160—
+3K152076PEEK Customized Cranial Implant, PEEK Customized Cranial Implant PriorityStryker20150—
+3K132519Stryker Customized Mandible Recon Plate KitStryker20133—
+4K261058CraniUS PlateCraniUS, LLC20261—
+4K250334Fusion Craniofacial Implant; Fusion Skull ImplantKelyniam Global, Inc.20250—
+4K231834VSP PEEK Cranial Implant3D Systems, Inc.20240—
+4K193136Stryker Customized Mandible Recon Plate KitStryker20201—
+4K191916Stryker CMF MEDPOR Priority Customized Implant KitStryker Leibinger GmbH & Co KG20191—
+4K190229Stryker PEEK Customized Cranial Implant KitStryker20191—
+4K190696Stryker Surgeon iD Mandible Recon PlateStryker20190—
+5K262874CraniUS PlateCraniUS, LLC20260—
+5K254233MEDPOR Customized Implant KitStryker Leibinger GmbH & Co KG20260—
+5K222650Stryker Cutomized Mandible Recon Plate; Stryker Surgeon iD Mandible Recon PlateStryker Craniomaxillofacial (Cmf)20220—
+5K203055Stryker PEEK Customized Cranial Implant KitStryker20210—