510(k) Report

Devices descending from K130319

12 later devices reach Medline Cannulated Screw through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K241359Medline UNITE® MIS Foot Recon Screw SystemMedline Industries, LP20241—
+1K234031Medline UNITE Ancillary Foot Recon Plating SystemMedline Industires, LP20241—
+1K220511Medline UNITE IM Fibula ImplantMedline Industries, LP20220—
+1K211612Medline UNITE REFLEX Dynamic DiscsMedline Industries, Inc.20211—
+1K211944Medline UNITE® Digital Fusion Screw SystemMedline Industries, Inc.20210—
+1K201319Medline UNITE Jones Fracture Screw SystemMedline Industires, Inc.20200—
+1K181820Medline Unite Mini Plates and ScrewsMedline Industries, Inc.20182—
+1K170782Medline UNITE® Snap-Off ScrewsMedline Industries, Inc.20170—
+1K162829Medline UNITE® Ankle Fracture Plating SystemMedline Industries, Inc.20161—
+2K250935TriMed Fifth Metatarsal System (Fifth Metatarsal Plate); TriMed Fifth Metatarsal System…TriMed, Inc.20250—
+2K243888Medline UNITE® REFLEX® Hybrid Nitinol Implant SystemMedline Industries, LP20250—
+2K221360Medline UNITE® Medial Malleolus Peg Plate SystemMedline Industries, LP20220—