Cleared Traditional

VELYS Robotic-Assisted Solution

K240211 · Depuy Ireland UC · Orthopedic

Jun 2024

Decision

132d

Days

Class 2

Risk

About This 510(k) Submission

K240211 is an FDA 510(k) clearance for the VELYS Robotic-Assisted Solution, a Orthopedic Stereotaxic Instrument (Class II — Special Controls, product code OLO), submitted by Depuy Ireland UC (Ringaskiddy, IE). The FDA issued a Cleared decision on June 5, 2024, 132 days after receiving the submission on January 25, 2024. This device falls under the Orthopedic review panel. Regulated under 21 CFR 882.4560.

Submission Details

510(k) Number	K240211 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 25, 2024
Decision Date	June 05, 2024
Days to Decision	132 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	OLO — Orthopedic Stereotaxic Instrument
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 882.4560
Definition	Stereotaxic Guidance During Orthopedic Surgery Procedures. Indicated For Orthopedic Joint Or Spine Surgery. Neurological Stereotaxic Instruments Are Classified Under Product Code Haw.