510(k) Report

Devices descending from K121153

13 later devices reach Peek Customized Craial Implant Kit through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K182711Customized Craniofacial Implant (CCI), Customized Skull Implant (CSI)Kelyniam Global, Inc.20194—
+1K153248PEEK Customized Cranial ImplantStryker20162—
+1K152076PEEK Customized Cranial Implant, PEEK Customized Cranial Implant PriorityStryker20150—
+1K132519Stryker Customized Mandible Recon Plate KitStryker20133—
+2K261058CraniUS PlateCraniUS, LLC20261—
+2K250334Fusion Craniofacial Implant; Fusion Skull ImplantKelyniam Global, Inc.20250—
+2K231834VSP PEEK Cranial Implant3D Systems, Inc.20240—
+2K193136Stryker Customized Mandible Recon Plate KitStryker20201—
+2K190229Stryker PEEK Customized Cranial Implant KitStryker20191—
+2K190696Stryker Surgeon iD Mandible Recon PlateStryker20190—
+3K262874CraniUS PlateCraniUS, LLC20260—
+3K222650Stryker Cutomized Mandible Recon Plate; Stryker Surgeon iD Mandible Recon PlateStryker Craniomaxillofacial (Cmf)20220—
+3K203055Stryker PEEK Customized Cranial Implant KitStryker20210—