Cleared Traditional

K252555 - Medusa Orthopedics Boa External Fixatio...

K252555 is an FDA 510(k) clearance for Medusa Orthopedics Boa External Fixatio..., manufactured by Medusa Orthopedics, LLC. The device is a Class 2 Orthopedic device with product code KTT cleared through the Traditional 510(k) pathway after a 104-day FDA review.

K252555 · Medusa Orthopedics, LLC · Orthopedic device
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Nov 2025
Decision
104d
Days
Class 2
Risk

K252555 is an FDA 510(k) clearance for the Medusa Orthopedics Boa External Fixation System. Classified as Appliance, Fixation, Nail/blade/plate Combination, Multiple Component (product code KTT), Class II - Special Controls.

Submitted by Medusa Orthopedics, LLC (Fleetwood, US). The FDA issued a Cleared decision on November 25, 2025 after a review of 104 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3030 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Medusa Orthopedics, LLC devices

FDA 510(k) Submission Details - K252555

510(k) Number K252555 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
18d faster than avg
Panel avg: 122d · This submission: 104d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KTT Device Classification - Class 2, Special Controls

Product Code KTT Appliance, Fixation, Nail/blade/plate Combination, Multiple Component
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3030
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Orthopedic devices follow this clearance model.

Regulatory Peers - KTT Appliance, Fixation, Nail/blade/plate Combination, Multiple Component

All 298
Devices cleared under the same product code (KTT) and FDA review panel - the closest regulatory comparables to K252555.
Excelsior System
K253291 · Blue Ocean Global · Jan 2026
Hoffmann LRF System
K253202 · Stryker GmbH · Dec 2025
Monkey Rings External Ring Fixation System
K253613 · Paragon 28, Inc. · Dec 2025
The Response Ortho Smart Fixator - Hexapod System
K252625 · Response Ortho Solutions, LLC · Nov 2025
External Fixation Mini Rail System
K252106 · Paragon 28, Inc. · Sep 2025
External Fixation Bone Distractor
K251862 · Paragon 28, Inc. · Aug 2025