# K253805: Knee+

- Pathway: 510(k) (Traditional)
- Applicant: Pixee Medical S.A.S.
- Decided: Apr 24, 2026 after 147 days
- Product code: SBF (Orthopedic Augmented Reality)
- Device class: 2
- Regulation: 21 CFR 882.4560
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K002053 (2000). 17 ancestors in all.
No later device cites it as a predicate yet.
2 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K243975: Knee+, Pixee Medical (2025) Summary page 5.

## Indications for use
Knee+ is a stereotaxic system including an intraoperative software as a medical device and surgical instruments. Knee+ is intended for primary Total Knee Replacement, to assist the surgeon in determining reference alignment axes in relation to anatomical landmarks, in order to position the cutting guide regarding computed mechanical axis. The Knee+ includes smart glasses as a Head Mounted Device (HMD) for displaying information to the user intraoperatively. The smart glasses should not be relied upon solely and should always be used in conjunction with traditional methods.

Source page: https://510kreport.com/device/K253805
Methodology: https://510kreport.com/methodology