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Alliance Medical Reprocessed External Fixation Devices

FDA 510(k)

Class II (US FDA 510(k))

510(k) K052064

by Alliance Medical, Inc.

Identifiers

510(k) Number
K052064 FDA 510(k)
FDA Product Code
KTT FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 888.3030 FDA 510(k)
Regulation Number
888.3030 FDA 510(k)
Advisory Committee
Orthopedic FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

This device is a reprocessed external fixation system, designed for skeletal stabilization and orthopedic applications. It is intended for use in the treatment of fractures, osteotomies, arthrodeses, deformity correction, limb lengthening, and reconstruction of bony or soft tissue defects. The system provides external skeletal support to maintain alignment and promote proper healing of complex bone injuries or deformities.

The devices are reprocessed for reuse after initial single-use intent, involving cleaning, sterilization, and potential repair. They are supplied as orthopedic hardware for use in clinical settings such as hospitals and surgical centers. The devices are regulated under FDA 510(k) clearance (K052064) as substantially equivalent to a predicate device, with classification under product code KTT. Sterility and reprocessing compliance are critical for safe reuse in orthopedic procedures.

Frequently asked questions

What is the reprocessed external fixation system used for?

This reprocessed external fixation system is designed for orthopedic applications, including the treatment of fractures, osteotomies, arthrodeses, deformity correction, limb lengthening, and reconstruction of bony or soft tissue defects. It provides external skeletal support to maintain alignment and promote proper healing of complex bone injuries or deformities.

How are these devices reprocessed for reuse?

The devices undergo a multi-step reprocessing procedure after their initial single-use intent, which includes thorough cleaning, sterilization, and potential repairs to ensure they meet safety and performance standards for reuse in clinical settings.

Are these devices sterile after reprocessing?

Yes, sterility is a critical part of the reprocessing process to ensure the devices are safe for reuse in orthopedic procedures. The reprocessing follows FDA-compliant protocols to maintain sterility and functionality.

What types of clinical settings use this external fixation system?

These devices are intended for use in clinical settings such as hospitals and surgical centers, where orthopedic surgeons perform procedures requiring external skeletal stabilization.

What regulatory clearance does this reprocessed external fixation system hold?

The system holds FDA 510(k) clearance (K052064) and is classified under product code KTT, with a decision of substantial equivalence to a predicate device. This clearance ensures it meets regulatory standards for reprocessed medical devices.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Alliance Medical Corporation Reprocessed External Fixation Devices ..., REPROCESSED EXTERNAL FIXATION DEVICE by ALLIANCE MEDICAL, INC. | FDA ..., K052062 FDA 510(k) - ALLIANCE MEDICAL CORPORATION REPROCESSE...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Alliance Medical, Inc.
FDA Applicant
Alliance Medical Corp.

Sources (1)

  • FDA 510(k) K052064 24 fields · synced Oct 5, 2026