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.

Device Description

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.

AI/ML Overview

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.

Summary

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510(k) Summary

ADMINISTRATIVE INFORMATION

Manufacturer Name:	X-spine Systems, Inc.452 Alexandersville Rd.Miamisburg, OH 45342
	Telephone (937) 847-8400FAX (937) 847-8410JAN 28 2002
Official Contact:	David Kirschman, MDChief Medical Officer

DEVICE NAME

Classification Names:	Spinal Intervertebral Body Fixation Orthosis
Trade/Proprietary Name:	Butrex ™ Buttress Plating System
Common Name:	Buttress Plating System

ESTABLISHMENT REGISTRATION NUMBER

X-spine Systems, Inc. has submitted an Establishment Registration to FDA. The Establishment Registration number is 3005031160. The owner/operator number for X-spine Systems, Inc. is 9063903.

DEVICE CLASSIFICATION

FDA has classified Spinal Intervertebral Body Fixation Orthoses as Class II devices (21 CFR 888.3060). The product code for spinal intervertebral body fixation Orthosis is KWQ. This device classification is reviewed by the Orthopedic Devices Branch.

INTENDED USE

The intended use of the Butrex Plating system and associated components is substantially equivalent to the intended use of predicate devices. The Butrex Plating System is intended for anterior intravertebral body screw fixation/attachment to the LI-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

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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.

DEVICE DESCRIPTION

Butrex Plates

Butrex Screws

Material composition

The components of the Buttress Plating System are made of titanium alloy conforming to ASTM F136.

EQUIVALENCE TO MARKETED PRODUCT

X-spine Systems, Inc. has submitted information to demonstrate that, for the purposes of FDA's regulation of medical devices, the Buttress Plating System is substantially equivalent in indications and design principles to predicate devices, which have been determined by FDA to be substantially equivalent to pre-amendment devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.

Public Health Service

JAN 28 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

X-spine Systems, Inc. % David Kirschman, M.D. Chief Medical Officer 452 Alexandersville, Rd. Miamisburg, OH 45342

Re: K072943

Trade/Device Name: ButrexTM Buttress Plating System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: KWO Dated: December 5, 2007 Received: December 6, 2007

Dear Dr. Kirschman:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - David Kirschman, M.D.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Mark M. Mulkerson

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Butrex Buttress Plating System

510(k): Premarket Notification

Indications for Use

510(k) Number (if known): KO72943

Device Name: Butrex™ Buttress Plating System

Indications for Use:

The Butrex Buttress 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.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark N. Wilkerson

510(k) N

(revised 12/2/07)

Regulation Number and Section

§ 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.