510(k) Report

Devices descending from K120802

11 later devices reach Ortholoc (TM) 3DI Locking Screws Ortholoc (TM) Bone Screws through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K151235Medline Foot Plates and ScrewsMedline Industries, Inc.201510—
+2K234031Medline UNITE Ancillary Foot Recon Plating SystemMedline Industires, LP20241—
+2K222665Medline UNITE® Ankle Fusion Plating SystemMedline Industries, Inc.20230—
+2K202959PolyLock Plating SystemFusion Orthopedics, LLC20201—
+2K181820Medline Unite Mini Plates and ScrewsMedline Industries, Inc.20182—
+2K171690Trident Extremity Fixation SystemTrident Orthopedics20180—
+2K162829Medline UNITE® Ankle Fracture Plating SystemMedline Industries, Inc.20161—
+3K250935TriMed Fifth Metatarsal System (Fifth Metatarsal Plate); TriMed Fifth Metatarsal System…TriMed, Inc.20250—
+3K243888Medline UNITE® REFLEX® Hybrid Nitinol Implant SystemMedline Industries, LP20250—
+3K221360Medline UNITE® Medial Malleolus Peg Plate SystemMedline Industries, LP20220—
+3K211843PolyLock Plating SystemFusion Orthopedics20220—