Medical Device Manufacturer · CA , Montreal

Orthosoft Inc. (d/b/a) Zimmer CAS - FDA 510(k) Cleared Devices

20 submissions · 20 cleared · Since 2017

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
1-20 of 20
Cleared Jun 04, 2026
Signature™ ONE System
K261510 · QHE
Orthopedic · 28d
Cleared May 21, 2026
ROSA® Shoulder System
K260582 · OLO
Orthopedic · 90d
Cleared Feb 04, 2026
Signature™ ONE System
K260104 · QHE
Orthopedic · 22d
Cleared Nov 13, 2025
Rosa® Knee System
K251314 · OLO
Orthopedic · 199d
Cleared Oct 18, 2024
ROSA® Knee System
K242864 · OLO
Orthopedic · 28d
Cleared Feb 21, 2024
ROSA® Shoulder System
K233199 · OLO
Orthopedic · 146d
Cleared Dec 12, 2023
Signature™ ONE System
K232425 · QHE
Orthopedic · 123d
Cleared Jun 13, 2023
OptiVu™ ROSA® MxR
K230567 · SBF
Orthopedic · 104d
Cleared May 23, 2023
ROSA Hip System
K231162 · LLZ
Radiology · 29d
Cleared Feb 22, 2023
Rosa Knee System
K230180 · OLO
Orthopedic · 30d
Cleared Jul 29, 2022
OptiVu ROSA MxR
K220733 · SBF
Orthopedic · 137d
Cleared Apr 22, 2022
ROSA® Knee System
K213708 · OLO
Orthopedic · 149d
Cleared Oct 12, 2021
Signature™ ONE System
K212560 · QHE
Orthopedic · 60d
Cleared Jun 05, 2020
Signature ONE System
K200615 · QHE
Orthopedic · 88d
Cleared Nov 05, 2019
iASSIST Knee System
K192080 · OLO
Orthopedic · 95d
Cleared Aug 30, 2019
Signature ONE System
K192074 · QHE
Orthopedic · 28d
Cleared Aug 23, 2019
Efficient Care 3D Planning
K183544 · LLZ
Radiology · 246d
Cleared Jun 05, 2019
Signature ONE System
K190595 · KWT
Orthopedic · 90d
Cleared Jan 24, 2019
ROSA Knee System
K182964 · OLO
Orthopedic · 91d
Cleared Dec 28, 2017
X-PSI Knee System
K171269 · JWH
Orthopedic · 241d
Filters