MX Monoaxial Pedicle Screw

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

510(k) Number

K042964 ↗

FDA Product Code

MNH

Device Class

Class II

Regulation

21 CFR Part 888.3070

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

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• What spinal regions is the MX Monoaxial Pedicle Screw designed to stabilize, and how does this affect its clinical use?

  The MX Monoaxial Pedicle Screw is specifically designed to stabilize the thoracic, lumbar, and sacral spine regions. This targeted design makes it suitable for addressing acute or chronic instabilities or deformities in these areas, particularly as an adjunct to spinal fusion procedures in skeletally mature patients. Its monoaxial nature allows for controlled angular movement, which can help maintain proper alignment during fusion.

• Is the MX Monoaxial Pedicle Screw reusable, or is it intended for single-use only? What does this mean for surgical planning?

  The MX Monoaxial Pedicle Screw is supplied sterile and explicitly intended for single-use only. This means each screw is packaged for one surgical procedure, reducing the risk of cross-contamination and ensuring sterility. Clinicians should plan accordingly, accounting for the number of screws needed per patient to avoid reuse, which could compromise patient safety and device performance.

• What size options are available for the MX Monoaxial Pedicle Screw, and why does this matter for surgeons?

  The MX Monoaxial Pedicle Screw comes in multiple sizes to accommodate varying anatomical requirements across patients. This variability is critical for surgeons because spinal anatomy differs significantly between individuals—especially in thoracic, lumbar, and sacral regions—ensuring a proper fit for secure fixation and minimizing risks like screw loosening or improper placement during fusion procedures.

• How is the MX Monoaxial Pedicle Screw regulated in the U.S., and what does its FDA clearance status imply for hospitals?

  The MX Monoaxial Pedicle Screw holds FDA 510(k) clearance (K042964), classified under the orthopedic category as a Special 510(k) submission. This status confirms it is deemed *substantially equivalent* to a legally marketed predicate device, meaning it meets FDA safety and effectiveness standards for spinal fixation. Hospitals can proceed with procurement and use with confidence, as it adheres to regulatory requirements for spinal stabilization adjuncts in fusion surgeries.