Cleared Traditional

Excelsior System

K253291 · Blue Ocean Global · Orthopedic

Jan 2026

Decision

113d

Days

Class 2

Risk

About This 510(k) Submission

K253291 is an FDA 510(k) clearance for the Excelsior System, a Appliance, Fixation, Nail/blade/plate Combination, Multiple Component (Class II — Special Controls, product code KTT), submitted by Blue Ocean Global (Miami, US). The FDA issued a Cleared decision on January 20, 2026, 113 days after receiving the submission on September 29, 2025. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number	K253291 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 29, 2025
Decision Date	January 20, 2026
Days to Decision	113 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	KTT — Appliance, Fixation, Nail/blade/plate Combination, Multiple Component
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3030