510(k) Report

Devices descending from K180446

2 later devices reach b-ONE Total Knee System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K222431b-ONER MOBIO Total Knee SystemB-One Ortho, Corp.20221—
+2K262341b-ONE® Mobio™ Total Knee System Revision Cemented Tibial Augments, Stem Extensions and…B-One Ortho, Corp.20260—