Blackstone Ascent Posterior Occipital Cervico-Thoracic (POCT) System

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

510(k) Number

K080394 ↗

FDA Product Code

KWP

Device Class

Class II

Regulation

21 CFR Part 888.3050

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• Blakstone Laminoplasty Fixation System

  Class II

  FDA 510(k) K043338 Active Cleared 18 Feb 2005

• Blackstone Spinal Fixation System Posterior Hooks

  Class II

  FDA 510(k) K013885 Active Cleared 1 Feb 2002

• Blackstone Peek Vertebral Body Replacement System

  Class II

  FDA 510(k) K033702 Active Cleared 31 Mar 2004

• Modification to Blackstone Modular Pedicle Screw System

  Class II

  FDA 510(k) K042514 Active Cleared 7 Oct 2004

• Blackstone Surgical Titanium Mesh System Angled End Rings

  Class II

  FDA 510(k) K032700 Active Cleared 9 Oct 2003

• Blackstone Ascent Poct System 5.5mm/3.0mm Single Axial Connector

  Class II

  FDA 510(k) K042100 Active Cleared 20 Sep 2004

See all devices from Blackstone Medical, Inc. →

• What specific spinal regions does the Blackstone Ascent POCT System stabilize, and why is this design important for certain patients?

  The Blackstone Ascent POCT System is designed to stabilize the occiput (skull base) through the cervical spine and into the upper thoracic region, specifically up to the T3 vertebra. This extended fixation is particularly important for patients requiring occipito-cervico-thoracic fusion, such as those with severe instability, trauma, or degenerative conditions affecting this complex junction. The system’s design ensures stability across multiple segments to promote proper spinal alignment and fusion.

• Is this device intended for reuse, or is it meant to be used only once? How should it be stored to maintain sterility?

  The Blackstone Ascent POCT System is explicitly intended for single-use only, as stated in its packaging and instructions. Since it is supplied sterile, proper storage in a clean, dry environment—protected from moisture, dust, and extreme temperatures—is critical to preserve sterility until use. Always follow the manufacturer’s storage guidelines to ensure the device remains uncontaminated.

• Can this device be used in an MRI setting, or are there any safety concerns related to imaging?

  No, the Blackstone Ascent POCT System is not MRI-safe. This means it should never be used in patients who require MRI imaging, as the metallic components could cause artifacts or pose a risk during the procedure. Always verify imaging plans preoperatively and consult the manufacturer’s instructions for full safety details.

• What types of surgical settings or procedures is this device approved for, and what kind of training is typically required?

  The device is approved for orthopedic surgical use in settings where spinal fusion procedures are performed, such as hospitals with neurosurgery or spine surgery departments. While the FDA has cleared it under Special Review (K080394), its use requires familiarity with posterior occipital-cervico-thoracic fixation techniques. Surgeons should have experience with similar spinal stabilization systems and adhere strictly to the manufacturer’s instructions for proper implantation.