Knee+
FDA 510(k) K253805 · Pixee Medical S.A.S.
510(k) numberK253805
Submission
- Device name
- Knee+
- Applicant
- Pixee Medical S.A.S.
Besançon, FR - Received
- November 28, 2025
- Decision date
- April 24, 2026
- 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 |
| 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 |
| K241525 | ExcelsiusXRSBF · Traditional | Globus Medical, Inc. | 07/08/2025SE |
Questions and answers
When was Knee+ cleared by the FDA?
Knee+ (K253805) received a 510(k) decision of Substantially Equivalent on April 24, 2026, 147 days after the submission was received.
What is the product code of K253805?
The FDA product code is SBF – Orthopedic Augmented Reality, a Class II (moderate risk) device regulated under 21 CFR 882.4560.