K250477 is an FDA 510(k) clearance for the NextAR(TM) Spine. This device is classified as a Orthopedic Augmented Reality (Class II - Special Controls, product code SBF).
Submitted by Medacta International S.A. (Castel San Pietro, CH). The FDA issued a Cleared decision on July 31, 2025, 162 days after receiving the submission on February 19, 2025.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 882.4560. 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..
| 510(k) Number | K250477 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 19, 2025 |
| Decision Date | July 31, 2025 |
| Days to Decision | 162 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | SBF — Orthopedic Augmented Reality |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.4560 |
| Definition | 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. |