The XPand Radiolucent 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 turnor or trauma (i.e., fracture). The XPand Radiolucent 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 Radiolucent Corpectomy Spacer is designed to provide anterior spinal column support even in the absence of fusion for a prolonged period.

Device Description

The XPand Radiolucent Corpectorny Spacer device 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 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 devices are made from radiolucent polymer, titanium alloy, and tantalum as specified in F2026. F136, F136, F1295, and F560.

AI/ML Overview

The XPand Radiolucent Corpectomy Spacer (K060665) underwent mechanical testing to demonstrate substantial equivalence to its predicate device, the XPand Corpectomy Spacer (K050850). The evaluation focused on mechanical performance in accordance with FDA guidance for spinal systems.

Here's an analysis of the provided information:

Acceptance Criteria and Device Performance

The document does not explicitly state numerical acceptance criteria in a table format, nor does it provide specific quantitative results of the device performance. Instead, it broadly states that:

Acceptance Criteria	Reported Device Performance
Mechanical testing in accordance with "Guidance for Industry and FDA Staff, Guidance for Spinal System 510(k)s", May 3, 2004.	Testing was performed in accordance with the specified guidance.
Substantial equivalence to predicate device (K050850) with respect to functional design, indications for use, principles of operation, and performance.	The device was found to be substantially equivalent.

Missing Information: Specific numerical acceptance criteria (e.g., strength, fatigue life) and the actual numerical results from the mechanical testing are not provided in the supplied text. The document only confirms that testing was done in accordance with the guidance and that substantial equivalence was found.

Study Details

Based on the provided text, the characteristics of the study are as follows:

Sample Size used for the test set and the data provenance: The document does not specify a "test set" in the context of clinical data for human or animal subjects. The evaluation focused on mechanical testing of the device itself. Therefore, the "sample size" likely refers to the number of devices or components tested, which is not detailed in the provided text. The data provenance is mechanical test data, not patient data.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The "ground truth" for this device's evaluation was established through mechanical engineering principles and testing standards outlined in the FDA guidance, not through expert clinical consensus on patient data.
Adjudication method for the test set: Not applicable. There was no clinical test set requiring adjudication. The assessment was based on objective mechanical measurements and comparison to predicate device performance.
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 is a medical device (spinal implant), not an AI/imaging diagnostic device. Therefore, no MRMC study, human readers, or AI assistance is relevant to its approval process as described.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is a medical device, not an algorithm.
The type of ground truth used: Mechanical testing standards and performance benchmarks derived from the predicate device. The "truth" is whether the device met the established mechanical requirements for its intended use and was comparable to the predicate.
The sample size for the training set: Not applicable, as this refers to a medical device's mechanical properties, not a machine learning model.
How the ground truth for the training set was established: Not applicable for the same reason as above.

In summary, the provided text details a regulatory submission for a medical device focusing on its mechanical performance and substantial equivalence to a legally marketed predicate device, rather than a clinical study evaluating an AI algorithm or diagnostic tool.

Summary

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510(K) Summary III.

SUBMITTED BY:

144 1 0 0000005

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

DEVICE NAME:

XPand Radiolucent 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 XPand Corpectomy Spacer K050850, SE date May 26, 2005 Globus Sustain Radiolucent Spacer K040284. SE date March 23, 2004

DEVICE DESCRIPTION:

The XPand devices are made from radiolucent polymer, titanium alloy, and tantalum as specified in F2026. F136, F136, F1295, and F560.

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INTENDED USE:

The XPand Radiolucent 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 is presented.

BASIS OF SUBSTANTIAL EQUIVALENCE:

The XPand Radiolucent Corpectomy Spacer implants are similar to the predicate vertebral body replacement device, XPand Corpectorny Spacer (K050850), with respect to functional design, indications for use, principles of operation, and performance. The material is changed to a radiolucent polymer that is being used in other legally marketed devices within the same classification regulation for the same intended use as the XPand Radiolucent Corpectomy Spacer.

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II. Indications for Use Statement

510(k) Number:	K060665
Device Name:	XPand Radiolucent Corpectomy Spacer

Indications:

The XPand Radiolucent 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 turnor or trauma (i.e., fracture). The XPand Radiolucent Corpectorny 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 Radiolucent Corpectomy Spacer is designed to provide anterior spinal column support even in the absence of fusion for a prolonged period.

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)

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the United States Department of Health and Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare, with three figures intertwined. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" is arranged in a circular fashion around the symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 1 0 2006

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

Re: K060665

Trade Name: XPand Radiolucent Corpectomy Spacer Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: MQP Dated: April 12, 2006 Received: April 13, 2006

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 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.

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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,

Helmut Lerner nos

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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Indications for Use Statement

510(k) Number:	K060665
----------------	---------

Device Name: XPand Radiolucent Corpectomy Spacer

Indications:

The XPand Radiolucent 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 Radiolucent 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 Radiolucent 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)

Hubert Lemer MD

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

510(k) Number K060665

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.