B-One Ortho, Corp. FDA Approvals

0 new drug approvals and 8 device clearances on file. This applicant is not matched to a listed company.

Newest first

A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.

Product	What it is	Route	Decided
b-ONE® Mobio Total Knee System Revision Cemented Tibial Augments, Stem Extensions and Press-Fit Stem Extensions510(k)Sep 8, 2026Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Sep 8, 2026
b-ONE® Bipolar Head510(k)Apr 13, 2026Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Apr 13, 2026
b-ONE® Total Hip System510(k)Nov 15, 2024Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Nov 15, 2024
b-ONER MOBIO Total Knee System510(k)Oct 6, 2022Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Oct 6, 2022
b-ONE MOBIO Total Knee System510(k)Jan 21, 2022Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Jan 21, 2022
OneFix Biocomposite Anchors, OneFix Biocomposite Small Anchors, OneFix All Suture Anchors, OneFix Interference Screws, OneFix Cannula System510(k)Nov 4, 2021Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Nov 4, 2021
MOBIO Total Knee System510(k)Apr 21, 2021Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Apr 21, 2021
KOSMO Femoral Stem510(k)Apr 1, 2021Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Apr 1, 2021