510(k) Report

Devices descending from K090053

8 later devices reach Aptus 2.0 Radial Head System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K243469SignexOsteonic Co., Ltd.20250—
+1K201656ARIX Elbow SystemJeil Medical Corporation20200—
+1K130774Universal Distal Radius SystemNewclip Technics20135—
+2K170843Alians Fragment SpecificNewclip Technics20171—
+2K142502Alians Ulna Locking Plating SystemNewclip Technics20142—
+3K213214Xpert WristNewclip Technics20210—
+3K211592Avanti Orthopaedics Ulnar Shortening SystemAvanti Orthopaedics, Inc.20211—
+4K261145Avanti Distal Elbow ORIF SystemAvanti Orthopaedics, LLC20260—