510(k) Report

Devices descending from K974289

25 later devices reach Epi-Union Plating System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K152289Alians Elbow Locking Plating SystemNewclip Technics20166—
+1K982545BMP Cable SystemBiomet, Inc.1998171
+2K261191Alians Elbow SNewclip Technics20260—
+2K173641Activ AnkleNewclip Technics20183—
+2K171372Alians Elbow Locking Plating SystemNewclip Technics20180—
+2K133354Peri-Prosthetic Cable SystemBiomet, Inc.20140—
+2K072250Supercable Grip and Plate SystemKinamed, Inc.200711
+2K043252Cabling System Trochanter HookSmith & Nephew, Inc.20051—
+2K031162Smith & Nephew Orthopaedic Cabling SystemSmith & Nephew, Inc.200310—
+2K023564Osse-LignOsseus, LLC20030—
+2K024022Osteo-Cable SleeveBiomet, Inc.20030—
+2K013657Modification to: Biomet Humeral Cable PlatesBiomet Orthopedics, Inc.20010—
+3K261511Xpert AnkleNewclip Technics20260—
+3K261038Xpert PFPNewclip Technics20260—
+3K233949ACCORD Cable SystemSmith & Nephew, Inc.20240—
+3K223762Smith & Nephew ACCORD™ Cable SystemSmith & Nephew20231—
+3K221395Footmotion Plating SystemNewclip Technics20220—
+3K213214Xpert WristNewclip Technics20210—
+3K203405EVOS Large Fragment Plating SystemSmith & Nephew, Inc.20213—
+3K201497EVOS Cabling SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)20200—
+3K173910Impress SFS SystemCable Fix Medical, LLC20180—
+3K123598Smith & Nephew, Inc. Hip System InstrumentationSmith & Nephew, Inc.201302
+4K213126Smith & Nephew, Inc. Plates and Screws Systems: EVOS, Peri-Loc, D-Rad, TC-100, VLP…Smith & Nephew, Inc.202221
+5K252019CurvaFix Low Profile SystemCurvafix, Inc.20250—
+5K233396Cannulated Screw SystemSmith & Nephew, Inc.20230—