(127 days)
The Blackstone Medical PEEK Vertebral Body Replacement System is indicated for use in the thoraco-lumbar spine (T1-L5) to replace a deseased vertebral body resected or excised for the treatment of tumors, to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The PEEK VBR System is also indicated for treating fractures of the thoracic and lumbar spine. It is recommended that bone graft material be packed inside the system prior to implantation. The PEEK VBR System is intended to be used with supplemental internal fixation. Specifically, the supplemental internal fixation system that may be used with the PEEK VBR System is the Blackstone Medical Spinal Fixation System.
Blackstone Medical, Inc. PEEK Vertebral Body Replacement (VBR) System is of a variety of components fabricated and manufactured from comprised Polyctheretherketone (PEEK Optima LT) as described by ASTM F-2026. This material is utilized due to its radiolucent properties, which aid the surgeon in determining if fusion in the operative site has occurred. Titanium markers are inserted into components to give surgeons a visual aid in determining the location of the implant both inter and postoperatively. The superior and inferior surfaces of the construct have a pattern of ripples to provide increased stability and help prevent lateral movement of the device.
The provided document is a 510(k) summary for the Blackstone PEEK Vertebral Body Replacement System. It does not contain information about acceptance criteria or a study proving that a device meets those criteria.
Instead, it's a submission to the FDA for market clearance based on substantial equivalence to a previously cleared device. The document explicitly states:
- Basis of Substantial Equivalence: "By its very nature, the Blackstone™ PEEK Vertebral Body Replacement System is substantially equivalent to the Blackstone Surgical Titanium Mesh System (K030744), which has been cleared by FDA for use in patients with tumor, trauma or fractures."
This means the manufacturer is asserting their device is similar enough to an already approved device that it doesn't require new clinical trials or the establishment of new performance acceptance criteria. The FDA's letter confirms that they have determined the device is "substantially equivalent."
Therefore, I cannot provide the requested information, as it is not present in the provided text. The document focuses on regulatory clearance via substantial equivalence, not on a study demonstrating adherence to specific performance acceptance criteria.
§ 888.3060 Spinal intervertebral body fixation orthosis.
(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.