(175 days)
The components of the Titanium Spinal Rod System are indicated for spinal fixation. When used as an anterolateral/anterior system consisting of rods and screws, the levels of attachment are the lumbar, thoracic and cervical spine. The points of attachment and methods are screw fixation to the anterolateral vertebral bodies of the lumbar and thoracic spine and the anterior vertebral bodies of the cervical spine. Intended uses for this device include anterolateral screw fixation to the noncervical spine, lumbar spine, T6-L5 spine and to the cervical spine. The indications are degenerative disc disease defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, fracture, spinal stenosis, deformities (i.e. scollosis, kyphosis, lordosis), tumor, pseudoarthrosis, multi-operated back or revision of previous surgery.
When used as a nonpedicle posterior system consisting of hooks, crosslinks, and sacral/iliac screws the levels of attachment are the lumbar, thoracic and cervical spine and the sacrum and ilium. Intended uses include hook and sacral screw fixation to the lumbar spine, noncervical spine and to the T1-S1 spine; and hook and sacral/iliac screw fixation to the noncervical spine. The indications are degenerative disc disease defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, fracture, spinal stenosis, deformities (i.e. scoliosis, kyphosis, lordosis), tumor, pseudoarthrosis, multi-operated back or revision of previous surgery.
When used as a posterior pedicle system consisting of hooks, crosslinks, sacral/iliac screws, pedicle screws and connectors the levels of attachment are the lumbar, thoracic and cervical spine and the sacrum and ilium. The device system using pedicle screws is intended for patients: (a) having severe spondylolisthesis (Grades 3 and 4) at the L5-S1 joint; (b) who are receiving fusions using autogenous bone graft only; (c) who are having the device fixed or attached to the lumbar and sacral spine; and (d) who are having the device removed after the development of a solid fusion mass. Although the levels of fusion may not go above the L5-S1 joint, the levels of pedicle screw fixation may be L3-SI.
The components of the Titanium Spinal Rod System are indicated for spinal fixation. When used as an anterolateral/anterior system consisting of rods and screws, the levels of attachment are the lumbar, thoracic and cervical spine. When used as a nonpedicle posterior system consisting of hooks, crosslinks, and sacral/iliac screws the levels of attachment are the lumbar, thoracic and cervical spine and the sacrum and ilium. When used as a posterior pedicle system consisting of hooks, crosslinks, sacral/iliac screws, pedicle screws and connectors the levels of attachment are the lumbar, thoracic and cervical spine and the sacrum and ilium. The devices are for single use. Cement fixation is not applicable to this device. The material used is implant grade material that conforms to ASTM F136 and ISO 5835/3 standards for wrought Titanium alloy (Ti-6Al-4V).
The provided text describes a medical device submission (K970635) for a Titanium Spinal Rod System. It outlines the intended uses and indications for various configurations of the system (anterolateral/anterior, nonpedicle posterior, and posterior pedicle). The FDA's response details specific limitations and warnings for the pedicle screw system, particularly regarding its use for severe spondylolisthesis at the L5-S1 joint.
However, the document does not contain information about:
- Acceptance criteria for performance (e.g., specific mechanical strength values, fatigue life, or biocompatibility thresholds).
- A "study that proves the device meets the acceptance criteria." The document states "The testing results were acceptable and the components should perform well in clinical usage," but provides no details about these tests, their methodology, or the actual results.
- Specific device performance metrics (numerical values) against acceptance criteria.
- Sample sizes used for test sets or data provenance (country of origin, retrospective/prospective).
- Number of experts used to establish ground truth or their qualifications.
- Adjudication method.
- Multi-reader multi-case (MRMC) comparative effectiveness study.
- Standalone (algorithm only) performance.
- Type of ground truth used (e.g., pathology, outcomes data).
- Sample size for the training set.
- How ground truth for the training set was established.
This document is a regulatory submission for a spinal implant system, focusing on its intended use, indications, materials, and FDA's clearance decision with specific labeling requirements, rather than a detailed report of performance testing results. The "Summary of Safety and Effectiveness" primarily details the device's design and intended use for regulatory review.
Therefore, I cannot populate the table or answer most of the questions based on the provided text.
§ 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.