NextAR(TM) Spine
FDA 510(k) K250477 · Medacta International S.A.
510(k) numberK250477
Submission
- Device name
- NextAR(TM) Spine
- Applicant
- Medacta International S.A.
Castel San Pietro, CH - Received
- February 19, 2025
- Decision date
- July 31, 2025
- 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 |
| K250108 | OptiVu ShoulderSBF · Traditional | Mr Surgical Solutions, LLC | 07/09/2025SE |
| K241525 | ExcelsiusXRSBF · Traditional | Globus Medical, Inc. | 07/08/2025SE |
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| K251043 | Mpact 3D Metal Implants Extension DMLS TechnologyLPH · Traditional | 01/28/2026SE |
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Questions and answers
When was NextAR(TM) Spine cleared by the FDA?
NextAR(TM) Spine (K250477) received a 510(k) decision of Substantially Equivalent on July 31, 2025, 162 days after the submission was received.
What is the product code of K250477?
The FDA product code is SBF – Orthopedic Augmented Reality, a Class II (moderate risk) device regulated under 21 CFR 882.4560.