510(k) Report

Devices descending from K152158

6 later devices reach ARIX Ankle System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K193616ARIX Ankle SystemJeil Medical Corporation20200—
+1K172008ARIX Humerus SystemJeil Medical Corporation20173—
+1K170979ARIX Ankle Fibula Hook Plate SystemJeil Medical Corporation20170—
+2K230938ARIX Humerus SystemJeil Medical Corporation20230—
+2K202912ARIX Ankle Distal Tibia SystemJeil Medical Corporation20201—
+3K232115TDM Large Bone Plate and Screw SystemTdm Co., Ltd.20240—