GPC BRAND Posterior, Non cervical Pedicle Screw Spinal System

510(k) Number

K163096 ↗

FDA Product Code

NKB

Device Class

Class II

Regulation

21 CFR Part 888.3070

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• Kirschner Wire, Single Ended - S.S.

  Class IIb

  CE/MDD

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  Class II

  FDA 510(k) K210198 Active Cleared 7 Jan 2022

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  Class II

  FDA 510(k) K203811 Active Cleared 10 Feb 2022

• GPC Intramedullary Nailing Systems

  Class II

  FDA 510(k) K143245 Active Cleared 30 Sep 2015

• Straight Plate with Gap, 1.5/2.0 mm - 2 Holes

  Class IIb

  CE/MDR

• fixLOCK DHS Plate 4.5 mm - 125° - S.S.

  Class IIb

  CE/MDR

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• What types of spinal procedures is this pedicle screw system designed to support as an adjunct?

  This system is specifically designed for spinal stabilization in the thoracolumbosacral region as an adjunct to spinal fusion procedures. It provides segmental fixation to help maintain alignment and support bone growth during fusion, particularly in skeletally mature patients.

• Is this device intended for use in the cervical spine, or is it limited to non-cervical regions only?

  The device is explicitly labeled as a non-cervical pedicle screw system, meaning it is intended only for use in the thoracolumbosacral spine—excluding the cervical vertebrae. This distinction is critical for proper surgical planning and patient selection.

• How is the GPC Brand Posterior Pedicle Screw System supplied, and what does single-use mean in this context?

  The system is supplied sterile and intended for single-use only, meaning each sterile package is designed for one surgical procedure. Reusing the device could compromise sterility and patient safety, so it must be discarded after use as per manufacturer guidelines.

• What regulatory pathway was followed for FDA clearance, and what does ‘substantially equivalent’ mean in this case?

  The device was cleared via the traditional 510(k) pathway under product code NKB, with a decision labeled as ‘Substantially Equivalent’ (SESE). This means the FDA determined that the device has the same intended use and technological characteristics as a legally marketed predicate device, ensuring it meets safety and effectiveness standards for spinal stabilization in the non-cervical spine.

• Are there multiple sizes or models available for this pedicle screw system, and if so, how might they differ?

  While the provided data does not specify exact sizes or models, the thoracolumbosacral pedicle screw system typically includes variations in screw length, diameter, and possibly pedicle screw head styles (e.g., polyaxial vs. fixed-angle) to accommodate different anatomical regions and patient anatomies. For precise sizing, refer to the manufacturer’s surgical technique guide or consult with GPC Medical’s technical support.