Blackstone Pedicle Screw System

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K082797 ↗

FDA Product Code

NKB

Device Class

Class II

Regulation

21 CFR Part 888.3070

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 types of spinal procedures is the Blackstone Pedicle Screw System intended for, and who is it designed for?

  The Blackstone Pedicle Screw System is specifically designed for posterior, non-cervical pedicle fixation in skeletally mature patients. It is intended to provide stable internal fixation during spinal fusion procedures, which may use autograft or allograft materials. This means it is used in surgeries where the spine’s stability needs reinforcement, such as in cases of spinal deformities, fractures, or degenerative conditions requiring fusion.

• Is the Blackstone Pedicle Screw System meant for reuse, or is it single-use only?

  The Blackstone Pedicle Screw System is explicitly designed for single-use in orthopedic surgical settings. This designation ensures sterility and safety for each patient, as reuse could compromise the device’s integrity and introduce infection risks. Always follow aseptic handling techniques when using it.

• How are the components of the Blackstone Pedicle Screw System supplied, and what precautions should be taken when handling them?

  The components of the Blackstone Pedicle Screw System are supplied sterile, meaning they are pre-packaged and ready for immediate use in a sterile surgical environment. Since they are sterile, proper aseptic techniques must be followed during handling to prevent contamination, such as using sterile gloves, instruments, and maintaining a clean field.

• What regulatory pathway was followed for FDA clearance of the Blackstone Pedicle Screw System, and what does this mean for its use?

  The Blackstone Pedicle Screw System received FDA 510(k) clearance through a Special Review process, specifically reviewed by the Orthopedic (OR) Advisory Committee. This clearance indicates that the device was determined to be substantially equivalent to a legally marketed predicate device, meaning it meets the same performance standards and safety requirements. Clinicians can rely on this clearance to confirm the device’s regulatory compliance for posterior, non-cervical pedicle fixation.