510(k) Report

Devices descending from K163044

13 later devices reach ORTHOLOC® 3Di Ankle Fracture Plating System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K230204ALPHALOK Plating SystemVilex, LLC20230—
+1K221558ALPHALOK Plating SystemVilex, LLC20222—
+1K213005Apollo Ankle Fracture Plating SystemGlw Medical, Inc.20221—
+1K212297Omni Foot and Ankle Plating SystemExtremity Medical, LLC20211—
+1K201259ORTHOLOC 2 with 3Di Technology Pilon Fracture Plating SystemWrightmedicaltechnologyinc20210—
+1K202764Ortho Solutions Plating SystemOrtho Solutions UK, Ltd.20201—
+1K170313ARIX Ankle Distal Tibia SystemJeil Medical Corporation20172—
+2K233816REDEMPTION Charcot Plating SystemVilex, LLC20240—
+2K221489Artemis Proximal Femoral Nail SystemGlw, Inc.20220—
+2K221362Omni Foot and Ankle Plating SystemExremity Medical, LLC20220—
+2K210658Volition Plating SystemOrtho Solutions UK, Ltd.20210—
+2K202912ARIX Ankle Distal Tibia SystemJeil Medical Corporation20201—
+3K232115TDM Large Bone Plate and Screw SystemTdm Co., Ltd.20240—