510(k) Report

Devices descending from K111323

2 later devices reach Synthes Synpor HD Porous Polyethylene Threr Dimensional Implants through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K133809Osteofab Patient Specific Facial DeviceOxford Performance Materials20141—
+2K161052OsteoFab Patient Specific Facial DeviceOxford Performance Materials, Inc.20160—