The XPAND Corpectomy Spacer is a vertebral body replacement device intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e., fracture). The XPAND Corpectomy Spacer is intended to be used with supplemental spinal fixation systems that have been labeled for use in the thoracic and/or lumbar spine (i.e., posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems). The interior of the spacer can be packed with bone grafting material.

The XPAND Corpectomy Spacer is designed to provide anterior spinal column support even in the absence of fusion for a prolonged period.

Device Description

The XPAND CORPECTOMY SPACER is a vertebral body replacement device used to provide structural stability in skeletally mature individuals following corpectomy or vertebrectomy. The system is comprised of spacers of various fixed heights and footprints to fit the anatomical needs of a wide variety of patients. Each spacer has an axial hole to allow grafting material to be packed inside of the spacer. Protrusions on the superior and inferior surfaces of each device will grip the endplates of the adjacent vertebrae to resist expulsion.

The XPAND Corpectomy Spacer devices are made from titanium alloy as specified in ASTM F1295 and F136.

AI/ML Overview

This document describes the marketing authorization for a medical device called the "XPAND Corpectomy Spacer". It is not a study that proves a device meets acceptance criteria, but rather a submission for substantial equivalence to a predicate device. Therefore, many of the requested categories (e.g., sample size for test/training set, number of experts, adjudication methods) are not applicable or cannot be extracted from this type of regulatory document.

However, I can provide the relevant information that is present in the document.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (What the device was tested against)	Reported Device Performance (Summary of results)
Mechanical testing in accordance with the "Guidance for Industry and FDA Staff, Guidance for Spinal System 510(k)s", May 3, 2004.	Performance data was "presented" and deemed sufficient to establish substantial equivalence.
Substantial equivalence to predicate device (Globus Sustain Spacer K031302) with respect to functional design, indications for use, principles of operation, and performance.	The XPAND Corpectomy Spacer was found to be substantially equivalent to the predicate device.

2. Sample size used for the test set and the data provenance

Sample Size: Not applicable. This document is a 510(k) summary for regulatory clearance, not a clinical study report. Mechanical testing was performed, but specific sample sizes for these tests are not provided.
Data Provenance: The document does not specify the country of origin for the mechanical testing data. The submission is for a US FDA clearance, so the testing would have been conducted to meet US regulatory guidance. The data is retrospective in the sense that it was generated prior to the 510(k) submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This is not a study requiring expert-established ground truth for a test set.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not applicable.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a physical medical implant, not an AI or imaging device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For mechanical testing, the "ground truth" would be established by the physical and mechanical properties and performance standards defined in the "Guidance for Spinal System 510(k)s".
For substantial equivalence, the "ground truth" is the established safety and effectiveness profile of the predicate device (Globus Sustain Spacer K031302).

8. The sample size for the training set

Not applicable. This is not an AI/machine learning study.

9. How the ground truth for the training set was established

Not applicable.

Summary

{0}------------------------------------------------

MAY 2 6 2005 .

III. 510(K) Summarv

SUBMITTED BY:

Globus Medical Inc. 303 Schell Lane Phoenixville, PA 19460 (610) 415-9000 x218 Contact: Kelly J. Baker

DEVICE NAME:

XPAND Corpectomy Spacer

CLASSIFICATION:

Per CFR 21 §888.3060: Implant, fixation, spinal intervertebral body fixation orthosis devices. Class II. The Product Code is MQP. The Panel Code is 87.

PREDICATE DEVICES:

Globus Sustain Spacer K031302, SE date June 27, 2003

DEVICE DESCRIPTION:

The XPAND Corpectomy Spacer devices are made from titanium alloy as specified in ASTM F1295 and F136.

INTENDED USE:

{1}------------------------------------------------

anterior screw and rod systems). The interior of the spacer can be packed with bone grafting material.

The XPAND Corpectomy Spacer is designed to provide anterior spinal column support even in the absence of fusion for a prolonged period.

PERFORMANCE DATA:

Mechanical testing in accordance with the "Guidance for Industry and FDA Staff, Guidance for Spinal System 510(k)s", May 3, 2004 was presented.

BASIS OF SUBSTANTIAL EQUIVALENCE:

The XPAND Corpectomy Spacer implants are similar to the predicate vertebral body replacement device, the Sustain Spacer (K031302), with respect to functional design, indications for use, principles of operation, and performance. The design is changed to an expandable spacer that is being used within the same classification regulation for the same intended use as the Sustain Spacer.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, representing the department's mission to protect the health of all Americans.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 2 6 2005

Kelly Baker, Ph.D. Project Manager, Regulatory Affairs Globus Medical Incorporated 303 Schell Lane Phoenixville, Pennsylvania 19460

Re: K050850

Trade Name: XPAND Corpectomy Spacer Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: MOP Dated: May 3, 2005 Received: May 4, 2005

Dear Dr. Baker:

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 includions 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, intern 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, TDA max publish further announcements concerning your device in the Federal Register.

{3}------------------------------------------------

Page 2 - Kelly Baker, Ph.D.

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. 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 Office 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 Manufacturers, 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.

A. Hyyt Rlrode
Minister-President, Ph.D.

Provost Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

ll. Indications for Use Statement

510(k) Number:	K050850
Device Name:	XPAND Corpectomy Spacer

Indications:

The XPAND Corpectomy Spacer is a vertebral body replacement device intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e., fracture). The XPAND Corpectomy Spacer is intended to be used with supplemented spinal fixation systems that have been labeled for use in the thoracic and/or lumbar spine (i.e., posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems). The interior of the spacer can be packed with bone grafting material.

The XPAND Corpectomy Spacer is designed to provide anterior spinal column support even in the absence of fusion for a prolonged period.

Prescription Use × (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)

At. Elvode

Division of General, Restorative, and Neurological Devices

510(k) Number_KO 50 850

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.