Cleared Traditional

Medusa Orthopedics Boa External Fixation System

K252555 · Medusa Orthopedics, LLC · Orthopedic

Nov 2025

Decision

104d

Days

Class 2

Risk

About This 510(k) Submission

K252555 is an FDA 510(k) clearance for the Medusa Orthopedics Boa External Fixation System, a Appliance, Fixation, Nail/blade/plate Combination, Multiple Component (Class II — Special Controls, product code KTT), submitted by Medusa Orthopedics, LLC (Fleetwood, US). The FDA issued a Cleared decision on November 25, 2025, 104 days after receiving the submission on August 13, 2025. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number	K252555 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 13, 2025
Decision Date	November 25, 2025
Days to Decision	104 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