B-One Ortho, Corp. is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
B-One Ortho, Corp. - FDA 510(k) Cleared Devices
Recent clearances: b-ONE® Bipolar Head, b-ONE® Total Hip System, b-ONER MOBIO Total Knee System
12
Total
12
Cleared
0
Denied
B-One Ortho, Corp. has 12 FDA 510(k) cleared orthopedic devices. Based in Cedar Knolls, US.
Latest FDA clearance: Apr 2026. Active since 2018.
Browse the complete list of FDA 510(k) cleared orthopedic devices from this manufacturer. Filter by specialty or product code using the sidebar.
510(k) submissions have been managed by Lakeshore Medical Device Consulting, LLC as regulatory consultant.
FDA 510(k) Regulatory Record - B-One Ortho, Corp.
12 devices
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
Cleared
Aug 30, 2018
b-ONE® Total Hip System
Orthopedic
304d