Cleared Traditional

K232176 - STELLAR Knee (FDA 510(k) Clearance)

K232176 · Polarisar, Inc. · Orthopedic device
Nov 2023
Decision
104d
Days
Class 2
Risk

K232176 is an FDA 510(k) clearance for the STELLAR Knee. This device is classified as a Orthopedic Augmented Reality (Class II - Special Controls, product code SBF).

Submitted by Polarisar, Inc. (Miami, US). The FDA issued a Cleared decision on November 2, 2023, 104 days after receiving the submission on July 21, 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 K232176 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 21, 2023
Decision Date November 02, 2023
Days to Decision 104 days
Submission Type Traditional
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.