(90 days)
Blackstone Spinal Fixation System is intended for non-cervical use in the spine.
The Blackstone Spinal Fixation System, when used for pedicle screw fixation, is intended only for patients:
a) Having severe spondylolisthesis (Grades 3 and 4) at the L5-S1 joint;
b) Who are receiving fusion using autogenous bone graft only;
c) Who are having the device fixed or attached to the lumbar and sacral spine (L3 and below): and
d) Who are having the device removed after the development of a solid fusion mass.
The Blackstone Spinal Fixation System, when used as a pedicle screw system in skeletally mature patients, is intended to provide immobilization and stabilization of spinal segments, as an adjunct to fusion, in treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine:
a) Degenerative spondylolisthesis with objective evidence of neurologic impairment:
b) Fracture;
c) Dislocation:
d) Scoliosis;
e) Kyphosis;
f) Spinal tumor: and
g) Failed previous fusion (pseudarthrosis).
The Blackstone Spinal Fixation System, when used for anterolateral non-pedicle fixation, is intended for the following indications:
a) Degenerative disc disease (as defined as back pain of discogenic origin with degenerative disc confirmed by patient history and radiographic studies);
b) Spinal stenosis:
c) Spondylolisthesis;
d) Spinal deformities (i.e., scoliosis, kyphosis, and/or lordosis);
e) Pseudarthrosis;
f) Tumor:
g) Trauma (i.e., fracture or dislocation);
h) Previous failed fusion.
The Blackstone™ Spinal Fixation System 4.5mm Mono-Axial Screw is a titanium alloy; multiple component system comprised of a variety of non-sterile, single use components that allow the surgeon to build a spinal implant construct. The system is attached to the vertebral body by means of screws to the non-cervical spine.
The Blackstone™ Spinal Fixation System consists of an assortment of screws and rods which have received 510k clearance (K994217 & K003735). The 4.5mm Mono-Axial Screws are new implant offerings, which are an adjunct and are fully interchangeable with the Spinal Fixation System (K994217 & K003735).
This is a 510(k) summary for a medical device (Blackstone Spinal Fixation System - 4.5mm Mono-Axial Screw System Addition), which describes its intended use and claims substantial equivalence to previously cleared devices. It is not a study report that evaluates the performance of the device against specific acceptance criteria using a test set.
Therefore, the requested information regarding acceptance criteria, device performance, sample sizes, ground truth establishment, expert qualifications, adjudication, and MRMC studies cannot be extracted because such a study is not part of this document.
Explanation:
- 510(k) Pre-Market Notification: This document is a 510(k) submission to the FDA. A 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective, i.e., substantially equivalent, to a legally marketed predicate device that is not subject to premarket approval (PMA).
- Substantial Equivalence: The fundamental principle of a 510(k) is to demonstrate "substantial equivalence" to a predicate device. This often involves comparing device design, materials, intended use, and performance characteristics to those of the predicate device. It typically does not require clinical trials or extensive performance studies with acceptance criteria in the same way a novel high-risk device might.
- Device Description and Indications for Use: The document clearly describes the device and its intended uses, comparing it to the predicate devices (DePuy Motech Moss Miami Spinal System).
- No Performance Data: There is no mention of specific performance metrics (e.g., accuracy, sensitivity, specificity, or mechanical properties under stress) for the new 4.5mm Mono-Axial Screw, nor is there any data from a study directly evaluating its performance against pre-defined acceptance criteria. The claim of equivalence is based on its similarity to the predicate device.
In summary, there is no study described in this document that proves the device meets acceptance criteria. The document serves as a regulatory submission demonstrating substantial equivalence to a predicate device, rather than a performance study report.
§ 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.