(68 days)
The STALIF™ TT device is indicated for the replacement, partial vertebrectomy and / or augmentation of a vertebral body due to destruction or partial destruction by tumor or fracture/trauma leading to the restoration of planar alignment, restoration of the height of the collapsed vertebral body and indirectly facilitating neural decompression. The device is designed to restore biomechanical integrity of the anterior, middle and posterior spinal column even in the absence of fusion for a prolonged period. The device is intended for use as a vertebral body replacement or partial replacement in the thoracolumbar spine (from T9 to L5). The STALIF™ TT device may be used with bone graft.
The Surgicraft STALIF™ TT is a radiolucent vertebral body replacement device used in coniunction with cancellous bone screws and is designed to restore biomechanical integrity from thoracic (T9 to T12) and lumbar spine (L1 to L5) following vertebrectomy or corpectomy for patients with spine tumors or traumal fracture. The system provides anterior column support both immediately after surgery and for prolonged periods in the absence of bone fusion.
This document is a 510(k) Premarket Notification summary for the STALIF TT™ System, a spinal intervertebral body fixation orthosis. It does not contain information typically found in a study proving a device meets acceptance criteria. A 510(k) submission generally relies on demonstrating substantial equivalence to a predicate device, rather than detailed performance study data against specific acceptance criteria.
Therefore, the requested information elements (acceptance criteria table, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, and training set details) cannot be extracted from this document as it is not a study report.
The document states: "Performance data were provided" under the "Substantial Equivalence" section, implying that some data was submitted, but the detailed results and methodology are not included in this summary.
Summary of available information:
- Device Name: STALIF TT™ System
- Intended Use: Replacement, partial vertebrectomy, and/or augmentation of a vertebral body due to destruction or partial destruction by tumor or fracture/trauma, to restore planar alignment, height, and facilitate neural decompression. Designed to restore biomechanical integrity of the spinal column (T9 to L5) for prolonged periods, even without fusion.
- Predicate Devices: DePuy AcroMed Stackable Cage™ System and Interpore Cross International GEO Structure.
- Substantial Equivalence: Claimed based on provided "Performance data." (Details of this data are not in this document).
§ 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.