(14 days)
The Construx™ PL/TL PEEK Partial VBR System is indicated for use in the thoracolumbar spine (TI-L5) for partial replacement (i.e., partial vertebrectomy) of a diseased 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 Construx™ PL/TL PEEK Partial VBR System is also indicated for treating fractures of the thoracic and lumbar spine.
The Construx™ PL/TL PEEK Partial VBR System is designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column even in the absence of fusion for a prolonged period of time. The Partial VBR device is intended to be used with bone graft material.
The Construx™ PL/TL PEEK Partial VBR System is intended for use with supplemental internal fixation. The supplemental internal fixation system that may be used with the Construx™ PL/TL PEEK Partial VBR System is the Blackstone Medical Spinal Fixation System.
Blackstone Medical, Inc. Construx™ PL/TL. PEEK Partial Vertebral Body Replacement (VBR) System is comprised of a variety of implants fabricated and manufactured from Polyetheretherketone (PEEK Optima LT1) 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. The teeth on the superior and inferior surfaces of the construct provide increased stability and help prevent anterior/posterior movement of the device.
The provided 510(k) K060350 for the Construx™ PL/TL PEEK Partial VBR System does not contain acceptance criteria or a study proving that the device meets specific performance criteria.
Instead, the submission primarily focuses on establishing substantial equivalence to previously cleared predicate devices based on:
- Similar intended use/indications for use: The device is indicated for partial replacement of diseased vertebral bodies, treatment of tumors and fractures in the thoracolumbar spine (T1-L5), and restoration of spinal column integrity. This aligns with the indications of the predicate devices.
- Similar device description: The device is comprised of PEEK material (ASTM F-2026), designed with teeth for stability, and intended for use with bone graft material and supplemental internal fixation. This is comparable to the predicate devices.
- Similar technological characteristics: The use of PEEK Optima LT1 for radiolucency and the design features are presented as similar to the Blackstone™ PEEK Mini Vertebral Body Replacement System (K051246) and the Blackstone™ PEEK Vertebral Body Replacement System (K033702).
Therefore, I cannot populate the table or answer the specific questions related to acceptance criteria and a study to prove they are met, as this information is not present in the provided document. The 510(k) process often relies on demonstrating that a new device is "substantially equivalent" to a legally marketed predicate device, rather than requiring new clinical trials or detailed performance studies with explicit 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.