K243950 is an FDA 510(k) clearance for the ARVIS® Shoulder. This device is classified as a Orthopedic Augmented Reality (Class II - Special Controls, product code SBF).
Submitted by Kico Knee Innovation Company Pty, Ltd. (Frenchs Forest, AU). The FDA issued a Cleared decision on January 13, 2025, 21 days after receiving the submission on December 23, 2024.
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 | K243950 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 23, 2024 |
| Decision Date | January 13, 2025 |
| Days to Decision | 21 days |
| Submission Type | Special |
| 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. |