(103 days)
The Butrex Plating System is intended for anterior intravertebral body screw fixation/attachment to the L1-S1 spine over one vertebral body extending onto the adjacent intervertebral space. Due to variations in the anatomy, the plate is designed for applications caudal to the bifurcation of the great vessels. Specifically, the device is intended for stabilization and buttressing of bone graft over one motion segment following anterior structural reconstruction for degenerative disc disease (DDD). DDD is defined as follows: back pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies.
Butrex plates are titanium alloy plates containing two sockets for screw placement on one end of the plate and a buttressing surface one the other end. The plate incorporates a locking mechanism to prevent screw back-out. The plates are provided in lengths of 22 mm, 26 mm, and 32 mm.
Butrex screws are titanium alloy screw with a self tapping thread design. Screw lengths of 16mm. 18mm and 20mm are available. The screws heads are dimensioned for either fixed or variable placement into the Butrex plate sockets.
The components of the Buttress Plating System are made of titanium alloy conforming to ASTM F136.
This document is a 510(k) summary for a medical device called the "Butrex™ Buttress Plating System." It outlines the administrative information, device description, intended use, and equivalence to marketed products. However, it does not contain information regarding traditional acceptance criteria, performance studies, or details about artificial intelligence (AI) algorithms.
The document is a premarket notification for a Class II medical device (Spinal Intervertebral Body Fixation Orthosis). The FDA's substantial equivalence determination mentioned in the letter indicates that the device is considered substantially equivalent to existing predicate devices, implying it meets the same safety and effectiveness standards. For devices of this nature, substantial equivalence is often established through material biocompatibility, mechanical testing (e.g., fatigue, static strength), and sometimes animal or cadaveric studies, rather than clinical trials with extensive performance metrics like sensitivity, specificity, or AI-assisted improvements.
Therefore, I cannot provide the requested information about acceptance criteria for device performance, study details, sample sizes, expert involvement, or AI-related metrics because it is not present in the provided text. The document focuses on regulatory approval based on equivalence to existing devices.
§ 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.