Cleared Traditional

VELYS? Hip Navigation

K253551 · Depuy Ireland UC · Radiology
Mar 2026
Decision
112d
Days
Class 2
Risk

About This 510(k) Submission

K253551 is an FDA 510(k) clearance for the VELYS? Hip Navigation, a System, Image Processing, Radiological (Class II — Special Controls, product code LLZ), submitted by Depuy Ireland UC (Ringaskiddy, IE). The FDA issued a Cleared decision on March 6, 2026, 112 days after receiving the submission on November 14, 2025. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number K253551 FDA.gov
FDA Decision Cleared SESE
Date Received November 14, 2025
Decision Date March 06, 2026
Days to Decision 112 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code LLZ — System, Image Processing, Radiological
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.2050