Medical Device Manufacturer · US , Cedar Knolls , NJ

B-One Ortho, Corp. - FDA 510(k) Cleared Devices

13 submissions · 13 cleared · Since 2018

Recent clearances: b-ONE® Mobio™ Total Knee System Revision Cemented Tibial Augments, Stem Extensions and Press-Fit Stem Extensions, b-ONE® Bipolar Head, b-ONE® Total Hip System

13

Total

13

Cleared

0

Denied

FDA 510(k) Regulatory Record - B-One Ortho, Corp. Orthopedic ✕

13 devices

1-12 of 13

Cleared Sep 08, 2026

b-ONE® Mobio™ Total Knee System Revision Cemented Tibial Augments, Stem...

Orthopedic · 60d

Cleared Apr 13, 2026

b-ONE® Bipolar Head

Orthopedic · 195d

Cleared Nov 15, 2024

b-ONE® Total Hip System

Orthopedic · 266d

Cleared Oct 06, 2022

b-ONER MOBIO Total Knee System

Orthopedic · 56d

Cleared Jan 21, 2022

b-ONE MOBIO Total Knee System

Orthopedic · 60d

Cleared Nov 04, 2021

OneFix Biocomposite Anchors, OneFix Biocomposite Small Anchors, OneFix All...

Orthopedic · 52d

Cleared Apr 21, 2021

MOBIO Total Knee System

Orthopedic · 61d

Cleared Apr 01, 2021

KOSMO Femoral Stem

Orthopedic · 192d

Cleared Oct 23, 2020

Mobio Total Knee System

Orthopedic · 59d

Cleared Feb 14, 2019

Juveno Hip System Femoral Stem, b-ONE Primary Acetabular System Cups

Orthopedic · 140d

Cleared Jan 28, 2019

MOBIO Total Knee System Posterior Stabilized (PS and PS+) Tibial Inserts,...

Orthopedic · 88d

Cleared Oct 12, 2018

b-ONE Total Knee System

Orthopedic · 234d