(87 days)
The system is intended for use anterolateral/anterior, non-pedicle posterior and posterior pedicle.
1.) The device system consisting of pedicle screws, washers, spacers, utilizing the anterolateral/anterior surgical approach is intended for the following uses:
a.) Anterolateral screw fixation to the non-cervical spine,
b.) Anterior screw fixation to the cervical spine.
The anterolateral/anterior system is intended for use in the following indications:
a.) Degenerative disc disease of the lumbar, thoracic and cervical spine relating to discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies.
b.) Spondylolisthesis
c.) Trauma
d.) Spinal Stenosis
e.) Scoliosis
f.) Kyphosis
g.) Tumor
h.) Pseudoarthrosis
i.) Previous failed fusion
2.) The device system consiting of hooks, screws, washers, spacer, when utilized as a non-pedicle posterior system is intended for use in the following:
a.) Hook and sacral/iliac screw fixation to the non-cervical spine.
The non-pedicle posterior system is intended for use in the following indications:
a.) Degenerative disc disease of the lumbar, thoracic and cervical spine relating to discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies.
b.) Spondylolisthesis
c.) Trauma
d.) Spinal Stenosis
e.) Scoliosis
f.) Kyphosis
g.) Tumor
h.) Pseudoarthrosis
i.) Previous failed fusion
3.) The device system of hooks, spacers, sacral/iliac screws and pedicle screws is intended for patients:
a.) Having a 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.
The levels of pedicle screws fixation are limited to L3-S1.
A spinal system consisting of screws, hooks, washers, spacer and plates/screws. The pedicle screws are available in four diameters from 5mm to 8mm, and vary in length from 30mm to 55mm. The spinal rods have a diameter of 4.75mm and vary in length from 50mm to 500mm. The anterior washers offer use with 5mm, 6mm, and 7mm screws. The Conical spacers are available in three heights from 7mm to 12mm, increasing in 2.5 increments. The lumbo-sacral rod/plate and screw incorporates lumbo-sacral rod/plates in three lengths from 80mm to 120mm, and bone screws with a 7mm diameter and lengths of 30mm to 45mm, increasing in 5mm increments. There are five laminar hooks and one pedicle hook with the range.
The distal tips of the pedicle screws are fluted to a point beyond the first thread, thus creating a self-tapping screw configuration.
The spinal rods have a diameter of 4.75mm and vary in length from 50mm to 500mm.
The locking mechanism between the rod and screw, as well as the rod and hook, features a three point clamping configuration in order to significantly reduce the risk of rod positioning and migration.
The devices are used to treat a number of spinal conditions.
The devices are manufactured from Titanium Alloy ASTM F1472-93 or Stainless Steel ASTM F138. Only components manufactured from the same material may be used in combination.
The provided text describes the "Whiteside Biomechanics Spinal System," a spinal fixation device, and its indications for use. However, it does not contain any information about acceptance criteria, device performance studies, or data related to AI/algorithm performance.
This document is a 510(k) summary (K991678) for a spinal system, which is a traditional medical device (implants, hardware) cleared through substantial equivalence to a predicate device. It is not an AI/ML medical device submission.
Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving device performance in the context of AI/ML, as that information is not present in the provided text.
The document primarily focuses on:
- Device Description: Components (screws, hooks, rods, washers, spacers, plates), their dimensions, and materials.
- Intended Use: Anterolateral/anterior, non-pedicle posterior, and posterior pedicle approaches.
- Indications for Use: Specific spinal conditions (degenerative disc disease, spondylolisthesis, trauma, spinal stenosis, scoliosis, kyphosis, tumor, pseudoarthrosis, previous failed fusion) and specific anatomical locations (non-cervical and cervical spine, L5-S1 joint for severe spondylolisthesis).
- Technological Comparison: Stating that it is a subset of, and identical to, the predicate device (The Corin Spinal System, K973425).
- FDA Clearance Letter: Confirming substantial equivalence based on the provided information.
§ 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.