510(k) Report

Devices descending from K112345

17 later devices reach Distal Volar Radius Plating Systems through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K162424Ulna Plating SystemBiomet, Inc.20160—
+1K140622DVR Dorsal Plate, DVR Lateral Plate, DVR Ulna PlateBiomet, Inc.201401
+1K133939Modified Distal Radius Plating SystemBiomet2014112
+1K132704Distal Radius Volar Rim Plate Standard, Distal Radius Volar Rim Plate NarrowBiomet201321
+2K191118Avanti Distal Radius and Forearm SystemAvanti Orthopaedics, Inc.20191—
+2K161665VLP Wrist Fracture SystemSmith & Nephew, Inc.201610—
+3K261145Avanti Distal Elbow ORIF SystemAvanti Orthopaedics, LLC20260—
+3K213126Smith & Nephew, Inc. Plates and Screws Systems: EVOS, Peri-Loc, D-Rad, TC-100, VLP…Smith & Nephew, Inc.202221
+3K210837Smith & Nephew Plates and ScrewsSmith & Nephew, Inc.202171
+3K181533EVOS Wrist Fracture Plating SystemSmith & Nephew, Inc.20189—
+4K253713Arthrex Variable Angle (VA) Proximal Tibia Plating SystemArthrex, Inc.20260—
+4K252019CurvaFix Low Profile SystemCurvafix, Inc.20250—
+4K243963Pediatric Plating Platform HipOrthoPediatrics Corp.20250—
+4K233396Cannulated Screw SystemSmith & Nephew, Inc.20230—
+4K233017TM Plating SystemTyber Medical, LLC20231—
+4K213123EVOS Wrist Spanning PlateSmith & Nephew, Inc.20220—
+5K261207Exalta Proximal Tibia Plating SystemTyber Medical, LLC20260—