Knee+— 510(k) K253805
Substantially EquivalentPixee Medical S.A.S.
FDA 510(k) clearance K253805 for Knee+, Substantially Equivalent on 2026-04-24. Applicant: Pixee Medical S.A.S.. Device class: 2.
Summary
Pixee Medical's Knee+ is filed under product code SBF (Orthopedic Augmented Reality). The record doesn't describe the product beyond its name and that code name.
Class II, 21 CFR 882.4560. The Orthopedic review panel handled it as a Traditional 510(k), though the record lists Neurology as the classification panel.
Pixee Medical filed from Besançon, France. The decision came 147 calendar days after FDA received it (November 28, 2025 to April 24, 2026).
Clearance details
- Applicant
- Pixee Medical S.A.S.
- Product code
- Product code SBF
- Device class
- Class 2
- Regulation
- 21 CFR 882.4560
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Besançon, FR
Recent devices under product code SBF
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