510(k) Report

Devices descending from K112560

8 later devices reach Aptus (R) Distal Humerus System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K201656ARIX Elbow SystemJeil Medical Corporation20200—
+1K171285ARIX Diaphysis SystemJeil Medical Corporation20176—
+2K180972ARIX Clavicle SystemJeil Medical Corporation20181—
+2K172008ARIX Humerus SystemJeil Medical Corporation20173—
+3K230938ARIX Humerus SystemJeil Medical Corporation20230—
+3K202912ARIX Ankle Distal Tibia SystemJeil Medical Corporation20201—
+3K191972ARIX Wrist SystemJeil Medical Corporation20190—
+4K232115TDM Large Bone Plate and Screw SystemTdm Co., Ltd.20240—