Orthosoft Inc. (d/b/a) Zimmer CAS is one of 208 FDA 510(k) medical device manufacturers from Canada in the dataset, ranked by real submission volume.
Orthosoft Inc. (d/b/a) Zimmer CAS - FDA 510(k) Cleared Devices
Recent clearances: Signature™ ONE System, ROSA® Shoulder System, Signature™ ONE System
20
Total
20
Cleared
0
Denied
Orthosoft Inc. (d/b/a) Zimmer CAS has 20 FDA 510(k) cleared orthopedic devices. Based in Montreal, CA.
Latest FDA clearance: Jun 2026. Active since 2017.
Browse the complete list of FDA 510(k) cleared orthopedic devices from this manufacturer. Filter by specialty or product code using the sidebar.
Regulatory submissions have been managed by Orthosoft Inc (D/B/A Zimmer Cas) and Orthosoft Inc. (D/B/A) Zimmer Cas). 1 submission has an FDA-authorized Predetermined Change Control Plan (PCCP), indicating AI or software-based device development.
FDA 510(k) Regulatory Record - Orthosoft Inc. (d/b/a) Zimmer CAS
20 devices
Cleared
Jun 04, 2026
Signature™ ONE System
Orthopedic
28d
Cleared
May 21, 2026
ROSA® Shoulder System
Orthopedic
90d
Cleared
Feb 04, 2026
Signature™ ONE System
Orthopedic
22d
Cleared
Nov 13, 2025
Rosa® Knee System
Orthopedic
199d
Cleared
Oct 18, 2024
ROSA® Knee System
Orthopedic
28d
Cleared
Feb 21, 2024
ROSA® Shoulder System
Orthopedic
146d
Cleared
Dec 12, 2023
Signature™ ONE System
Orthopedic
123d
Cleared
Jun 13, 2023
OptiVu™ ROSA® MxR
Orthopedic
104d
Cleared
May 23, 2023
ROSA Hip System
Radiology
29d
Cleared
Feb 22, 2023
Rosa Knee System
Orthopedic
30d
Cleared
Jul 29, 2022
OptiVu ROSA MxR
Orthopedic
137d
Cleared
Apr 22, 2022
ROSA® Knee System
Orthopedic
149d
Cleared
Oct 12, 2021
Signature™ ONE System
Orthopedic
60d
Cleared
Jun 05, 2020
Signature ONE System
Orthopedic
88d
Cleared
Nov 05, 2019
iASSIST Knee System
Orthopedic
95d
Cleared
Aug 30, 2019
Signature ONE System
Orthopedic
28d
Cleared
Aug 23, 2019
Efficient Care 3D Planning
Radiology
246d
Cleared
Jun 05, 2019
Signature ONE System
Orthopedic
90d
Cleared
Jan 24, 2019
ROSA Knee System
Orthopedic
91d
Cleared
Dec 28, 2017
X-PSI Knee System
Orthopedic
241d