Cleared Special

K230789 - Knee+ (FDA 510(k) Clearance)

K230789 · Pixee Medical · Orthopedic device
Apr 2023
Decision
30d
Days
Class 2
Risk

K230789 is an FDA 510(k) clearance for the Knee+. This device is classified as a Orthopedic Augmented Reality (Class II - Special Controls, product code SBF).

Submitted by Pixee Medical (Besancon, FR). The FDA issued a Cleared decision on April 21, 2023, 30 days after receiving the submission on March 22, 2023.

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 User’s Field Of View..

Submission Details

510(k) Number K230789 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 22, 2023
Decision Date April 21, 2023
Days to Decision 30 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

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 User’s Field Of View.