OptiVu ROSA MxR
FDA 510(k) K220733 · Orthosoft Inc (D/B/A Zimmer Cas)
510(k) numberK220733
Submission
- Device name
- OptiVu ROSA MxR
- Applicant
- Orthosoft Inc (D/B/A Zimmer Cas)
Montreal, CA - Received
- March 14, 2022
- Decision date
- July 29, 2022
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- SBF – Orthopedic Augmented Reality
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 882.4560
- Specialty
- Neurology
An orthopedic augmented reality device provides visual guidance during orthopedic procedures, where the use of stereotaxic navigation is utilized. Visual guidance is displayed as augmented reality stereoscopic images to intraoperatively augment the users field of view.
Other 510(k)s with product code SBF
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261854 | xvision Spine systemSBF · Traditional | Augmedics, Ltd. | 07/31/2026SE |
| K253805 | Knee+SBF · Traditional | Pixee Medical S.A.S. | 04/24/2026SE |
| K252847 | NextAR Hip PlatformSBF · Traditional | Medacta International S.A. | 01/09/2026SE |
| K251639 | xvision Spine systemSBF · Traditional | Augmedics, Ltd. | 10/03/2025SE |
| K252054 | SpineAR SNAP (SyncAR Spine)SBF · Traditional | Surgical Theater, Inc. | 09/29/2025SE |
| K252530 | OptiVu ShoulderSBF · Special | Mr Surgical Solutions, LLC | 09/10/2025SE |
| K251737 | NextAR(TM) Shoulder PlatformSBF · Traditional | Medacta International S.A. | 09/04/2025SE |
| K252170 | OptiVu ShoulderSBF · Special | Mr Surgical Solutions, LLC | 08/08/2025SE |
| K250477 | NextAR(TM) SpineSBF · Traditional | Medacta International S.A. | 07/31/2025SE |
| K250108 | OptiVu ShoulderSBF · Traditional | Mr Surgical Solutions, LLC | 07/09/2025SE |
More from Mr Surgical Solutions, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K261510 | Signature ONE SystemQHE · Special | 06/04/2026SE |
| K260582 | ROSA® Shoulder SystemOLO · Traditional | 05/21/2026SE |
| K260104 | Signature ONE SystemQHE · Special | 02/04/2026SE |
| K251314 | Rosa® Knee SystemOLO · Traditional | 11/13/2025SE |
| K242864 | ROSA® Knee SystemOLO · Special | 10/18/2024SE |
| K233199 | ROSA® Shoulder SystemOLO · Traditional | 02/21/2024SE |
| K232425 | Signature ONE SystemQHE · Traditional | 12/12/2023SE |
| K230567 | OptiVu ROSA® MxRSBF · Traditional | 06/13/2023SE |
| K231162 | ROSA Hip SystemLLZ · Special | 05/23/2023SE |
| K230180 | Rosa Knee SystemOLO · Special | 02/22/2023SE |
Questions and answers
When was OptiVu ROSA MxR cleared by the FDA?
OptiVu ROSA MxR (K220733) received a 510(k) decision of Substantially Equivalent on July 29, 2022, 137 days after the submission was received.
What is the product code of K220733?
The FDA product code is SBF – Orthopedic Augmented Reality, a Class II (moderate risk) device regulated under 21 CFR 882.4560.