Monotube External Fixation System

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K910483 ↗

FDA Product Code

KTT

Device Class

Class II

Regulation

21 CFR Part 888.3030

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

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• What types of bone injuries or conditions is the Monotube External Fixation System primarily used to treat?

  The Monotube External Fixation System is designed to stabilize long bone fractures or correct deformities by maintaining proper alignment externally. It is particularly suited for orthopedic and trauma cases where external skeletal fixation is required to distribute forces across the bone and promote healing, such as complex fractures or post-surgical stabilization.

• Is the Monotube External Fixation System intended for single-use or can it be reused after proper cleaning and sterilization?

  The Monotube External Fixation System is explicitly described as a reusable medical device. However, it must be assembled and applied under sterile conditions following standard surgical protocols to ensure patient safety and device integrity.

• What regulatory pathway was followed for FDA clearance of the Monotube External Fixation System, and what does this mean for its use?

  The Monotube External Fixation System received FDA clearance through a Traditional 510(k) process, categorized under product code KTT for external fixation devices. This means it was determined to be substantially equivalent to a legally marketed predicate device, allowing it to be marketed in the U.S. under the specified indications for external skeletal fixation.

• How is the Monotube External Fixation System supplied, and what considerations should be made during storage?

  The system is supplied as a reusable device, meaning it is not pre-sterilized for single-use. Since it requires sterile assembly and application, it should be stored in a clean, dry environment to prevent contamination. Proper cleaning and sterilization protocols must be followed before reuse to maintain its integrity and safety for subsequent procedures.