The GraftCage™ ACX is a vertebral body replacement device intended to replace a collapsed, damaged, or unstable vertebral body in the thoracic or lumbar spine (TI-L5). The GraftCage™ ACX is indicated for a partial or total vertebrectomy for cases of tumor or trauma (i.e., fracture). The GraftCage™ ACX is intended to achieve anterior decompression of the spinal cord and neural tissues and to restore the height of a collapsed vertebral body.

The GraftCage™ ACX is intended for use with supplemental internal spinal fixation systems that are cleared by FDA for use in the thoracic and lumbar spine. These systems include posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems.

The use of bone grafting material with the GraftCage™ ACX is optional.

Device Description

The GraftCage™ ACX is a device designed to replace a thoracic or lumbar vertebral body and to support axial compression loads following vertebrectomy for the treatment of spinal tumors and in bases of spinal trauma/fracture. The GraftCage™ ACX is made from implantable PEEK-OPTIMA (polyetheretherketone) polymer.

The GraftCage™ ACX is basically rectangular in shape. One central (axial) fenestration and one fenestration on each lateral aspect (on certain sizes) provide locations for the addition of bone grafting material. The superior and inferior aspects have ridges that resist expulsion and for migration after implantation. The device offers lordotic and non-lordotic i.e., parallel configurations. The posterior aspect of both design configurations is tapered, or bulleted, for ease of insertion.

A single threaded hole at the posterior aspect interfaces with the insertion tool. The insertion tool is a shaft attached to a handle. The shaft has a threaded end that matches the threaded hole on the GraftCage™ ACX and allows the surgeon to hold the GraftCage™ ACX while implanting it into the patient.

AI/ML Overview

The provided text is a 510(k) summary for the GraftCage™ ACX, a vertebral body replacement device. It details the device's description, intended use, and comparison to predicate devices, and includes the FDA's clearance letter. However, it does not contain any information about acceptance criteria or a study that proves the device meets specific performance criteria through empirical data.

The text primarily focuses on demonstrating substantial equivalence to existing legally marketed predicate devices rather than providing detailed performance study data against defined acceptance criteria. The statement "Performance data demonstrates that the GraftCage™ ACX meets or exceeds functional requirements for a vertebral body replacement device" is made, but no specifics of this data, the requirements, or the study methodology are provided in this document.

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets them with the information given. All the requested points (table of acceptance criteria, sample sizes, expert qualifications, adjudication methods, MRMC study, standalone performance, ground truth types, training set size, and ground truth establishment for training set) are not present in this document.

Summary

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2005 DEC 1

510(k) Summary GraftCage™ ACX

October 28, 2005
Submitted By:	Osteotech, Inc.
Address:	51 James WayEatontown, New Jersey 07724
Telephone:	(800) 537-9842, Ext. 6324
Contact Person:	Christopher TalbotDirector, Regulatory Affairs
Subject Device
Trade Name:	GraftCage™ ACX
Common Name:	Vertebral Body Replacement Device
Classification Name:	Spinal Intervertebral Body Fixation Orthosis

Device Description:

Intended Use:

【 - 】

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Comparison to Predicate:

The GraftCage™ ACX claims substantial equivalence to:

Osteotech, Inc. VBR, K012254 1)
DePuy AcroMed VBR System, K030833/K031635; 2)
Spinal Concepts Fortitude Vue Vertebral Body Replacement Device, K05100; and 3)
Implex Corporation Hedrocel Vertebral Body Replacement System, K010378. 4)

This claim of substantial equivalence is intended to reflect FDA's definition of substantial equivalence as defined by 21 CFR Part 807, Subpart E and is not intended to reflect a claim of substantial equivalence in terms of intellectual property.

The GraftCage™ ACX and the predicate devices have the same intended use and similar technological characteristics. Performance data demonstrates that the GraftCage™ ACX meets or exceeds functional requirements for a vertebral body replacement device.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three heads, representing the department's commitment to health, human services, and science. The eagle is surrounded by a circular border with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" written around it.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 2005

Christopher Talbot Director Regulatory Affairs Osteotech, Inc. 51 James Way Eatontown, New Jersey 07724

Re: K053080

Trade/Device Name: GraftCage™ ACX Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: MQP Dated: November 1, 2005 Received: November 2, 2005

Dear Mr. Talbot:

We have reviewed your Section 510(k) premarket notification of intent to market the device w one reviews. Jour cooleremined the device is substantially equivalent (for the indications for referenced 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 r your de hive t 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-Christopher Talbot

This letter will allow you to begin marketing your device as described in your Section 510(k) I mo lotet watification. The FDA finding of substantial equivalence of your device to a legally premaince notification - 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 11 you don't e epice of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small general international and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

CM. N. Mikkelsen

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

Enclosure

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1053080

GraftCage™ ACX 510(k) Notification Osteotech, Inc.

INDICATIONS FOR USE STATEMENT

510(k) NUMBER (IF KNOWN):

DEVICE NAME: GraftCage™ ACX

INDICATIONS FOR USE:

The GraftCage™ ACX is a vertebral body replacement device intended to replace a collapsed, damaged, or unstable vertebral body in the thoracic or lumbar spine (TI-L5). The GraftCage™ ACX is indicated for a partial or total vertebrectorny for cases of turnor or trauma (i.e., fracture). The GraftCage™ ACX is intended to achieve anterior decompression of the spinal cord and neural tissues and to restore the height of a collapsed vertebral body.

The use of bone grafting material with the GraftCage™ ACX is optional.

Prescription Use X (Per 21 CFR 801.109)

Over-The-Counter-Use

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices

510(k) Number	C053080
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C-1

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.