The XY cor™ Spinal Implant is indicated for use as a vertebral body replacement device intended for use in the thoracic and/or thoracolumbar spine (T3-L5) to replace a collapsed, damaged, or unstable vertebral body resected or excised (i.e., partial or total vertebrectomy procedures) due to tumor or trauma (i.e., fracture). The XYcor™ Spinal Implant is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column even in the absence of fusion for a prolonged period.

The XY cor™ Spinal Implant is intended for use with bone graft and supplemental internal fixation. The supplemental internal fixation systems that may be used with the X Y cor™ System include Medtronic Sofamor Danek TSRH 3D, DePuy Spine Expedium or Monarch pedicle screw fixation systems, Biomet, Polaris, Array or Omega-21 pedicle screw fixation systems, and other pedicle screw-rod/plate fixation systems that have biomechanical properties similar to those of the above-listed systems, including trans-facet fixation systems but excluding semi-rigid or flexible rod-screw systems.

Device Description

The XYcor™ Spinal Implant is a vertebral body replacement device fabricated from titanium. The XYcor™ Spinal Implant deploys with a self-locking mechanism. The footprint of XY cor™ Spinal Implant prior to deployment is of comparable size and shape to the DEVEX™ System and, after deployment, is of comparable size to the InFix® System.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied)	Reported Device Performance
Sufficient strength for static loading modes.	"The XYcor™ Spinal Implant demonstrated sufficient strength for static... compressive and torsional loading modes..."
Sufficient strength for dynamic compressive loading modes.	"The XYcor™ Spinal Implant demonstrated sufficient strength for... dynamic compressive and torsional loading modes..."
Sufficient strength for dynamic torsional loading modes.	"The XYcor™ Spinal Implant demonstrated sufficient strength for... dynamic... torsional loading modes..."
Resistance to subsidence.	"The XYcor™ Spinal Implant demonstrated... resistance to subsidence..."
Resistance to expulsion.	"The XYcor™ Spinal Implant demonstrated... resistance to... expulsion."
Not raise any issues on the safety of the device.	"The results did not raise any issues on the safety... of the device."
Not raise any issues on the effectiveness of the device.	"The results did not raise any issues on the... effectiveness of the device."
Comparable material, intended use, basic design concept, size of footprint, and biomechanical properties to the INFIX® System (K010530).	The device is stated to be "substantially equivalent to INFIX® System... in material, intended use, basic design concept, size of the footprint, and biomechanical properties." (This is a comparative criterion rather than an absolute performance metric for the XYcor itself, but serves as an acceptance criterion for substantial equivalence).
Comparable self-locking mechanism after distraction to the SYNEX™ Spacer System (K003836).	The device is stated to be "also substantially equivalent to the SYNEX™ Spacer System... in its self-locking mechanism after distraction." (Again, a comparative criterion for substantial equivalence).
Comparable shape prior to deployment and posterior approach used in surgical placement to the DEVEX™ System (K023835).	The device is stated to be equivalent to "the DEVEX ™ System... in its shape prior to deployment and the posterior approach used in surgical placement." (Again, a comparative criterion for substantial equivalence).

Note: The acceptance criteria are largely implied from the "Performance Data" section. This document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed, explicit acceptance criteria with specific numerical thresholds typical of a full design verification report.

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify a sample size for a test set. The reported "Performance Data" refers to "Mechanical testing" but does not detail the number of units tested. This is a common characteristic of 510(k) summaries where detailed testing protocols and results (including sample sizes) are typically found in the full submission, not the summary.

Furthermore, there is no information provided on data provenance (e.g., country of origin, retrospective or prospective nature of clinical data). The evaluation appears to be based solely on mechanical testing, not clinical studies involving patient data in the typical sense.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

This information is not provided and is not relevant for the type of study described. The study is a mechanical engineering test on a medical device, not an image-based diagnostic or clinical study requiring expert ground truth for interpretation.

4. Adjudication Method

This information is not provided and is not relevant for the type of study described (mechanical testing).

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The submission relies on mechanical testing to demonstrate substantial equivalence to predicate devices, not improvement in human reader performance.

6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance)

Yes, a standalone performance study in the form of mechanical testing was performed. The "Performance Data" section states, "Mechanical testing was performed on the XYcor™ Spinal Implant and the results are presented." This implies the device was tested independently of human interaction in simulating its intended biomechanical function.

7. Type of Ground Truth Used

The "ground truth" for this study is based on engineering standards and established biomechanical testing methodologies for vertebral body replacement devices. The performance metrics (strength for static/dynamic loading, resistance to subsidence/expulsion) are evaluated against pre-defined engineering requirements and comparison to predicate devices, rather than expert consensus, pathology, or outcomes data which are typically associated with clinical studies.

8. Sample Size for the Training Set

This information is not applicable as this is not a study involving machine learning or algorithms that require a training set. The study describes mechanical testing of a physical device.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable as there is no training set for this type of mechanical testing study.

Summary

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5. 510(k) Summary as required by 21 CFR 807.92(c)

510(k) Owner:	Vertebration, Inc.3375 Brentwood CourtPowell, OH 43065Phone: (614) 437-2027Facsimile: (614) 437-2034	APR 20 2007
Contact person:	Barbara S. Fant, Pharm.D.Clinical Research Consultants, Inc.310 Terrace AvenueSuite 201Cincinnati, OH 45220Phone: (513) 961-8200Facsimile: (513) 961-2858
Date:	January 5, 2007
Trade Name:	XYcorTM Spinal Implant for Minimally Invasive Spinal Surgery
Common name:	Vertebral body replacement device
Classification Name:	Spinal Intervertebral body fixation orthosis21 CFR 888.3060
Product Code:	MOD

Identification of a Legally Marketed Predicate Device

The XY cor™ Spinal Implant is substantially equivalent to the InFix® System marketed by Abbott Spine, 510(k) Premarket Notification Number: K031672, FDA Product Code MQP. Secondly, it is substantially equivalent to the SYNEX™ System manufactured by Synthes Spine, 510(k) Premarket Notification Number: K003836, FDA Product Code MQP; and, to the DEVEX™ System manufactured by DePuy Spine; 510(k) Premarket Notification Number: K023835, FDA Product Code MQP.

General Description

Vertebration, Inc. Proprietary and Confidential Information

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Intended Use

Performance Data

Mechanical testing was performed on the XY cor™ Spinal Implant and the results are presented. The XYcor™ Spinal Implant demonstrated sufficient strength for static and dynamic compressive and torsional loading modes and resistance to subsidence and expulsion. The results did not raise any issues on the safety or effectiveness of the device.

Basis of Substantial Equivalence

The XYcor™ Spinal Implant is substantially equivalent to INFIX® System manufactured by Abbott Spine under 510(k) Premarket Notification Number K010530, FDA Product Code MQP, and regulation 21CFR888.3060 (spinal intervertebral body fixation orthosis) in material, intended use, basic design concept, size of the footprint, and biomechanical properties. Secondly, it is also substantially equivalent to the SYNEX™ Spacer System manufactured by Synthes Spine under 510(k) Premarket Notification Number K003836, FDA Product Code MQP, and regulation 21CFR&888.3060 (spinal intervertebral body fixation orthosis) in its self-locking mechanism after distraction, and to the DEVEX ™ System manufactured by DePuy Spine under 510(k) Premarket Notification Number K023835, FDA Product Code MQP, and regulation 21CFR§888.3060 (spinal intervertebral body fixation orthosis) in its shape prior to deployment and the posterior approach used in surgical placement.

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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 with three stripes forming its wing, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the eagle. The logo is black and white.

APR 2 0 2007

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Vertebration Incorporated c/o Dr. Barbara Fant 310 Terrace Avenue - Suite 201 Cinncinnati, Ohio 45220

Re: K070082

Trade Name: XYcor™ Spinal Implant Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: MQP Dated: March 19, 2007 Received: March 21, 2007

Dear Dr. Fant:

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 – Dr. Barbara Fant

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,

Mark A. Mellekson

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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4. Indications for Use Statement

510(k) Number (if known): K070082

Device Name: XYcor™ Spinal Implant

Indications for Use:

The XY cor™ Spinal Implant is indicated for use as a vertebral body replacement device intended for use in the thoracic and/or thoracolumbar spine (T3-L5) to replace a collapsed, damaged, or unstable vertebral body resected or excised (i.e., partial or total vertebrectomy procedures) due to tumor or trauma (i.e., fracture). The XY cor™ Spinal implant is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column even in the absence of fusion for a prolonged period.

The XY cor™ Spinal Implant is intended for use with bone graft and supplemental internal fixation. The supplemental internal fixation systems that may be used with the X Y cor™ Spinal Implant include Medtronic Sofamor Danek TSRH 3D, DePuy Spine Expedium or Monarch pedicle screw fixation systems, Biomet, Polaris, Array or Omega-21 pedicle screw fixation systems, and other pedicle screw-rod/plate fixation systems that have biomechanical properties similar to those of the above-listed systems, including trans-facet fixation systems but excluding semi-rigid or flexible rod-screw systems.

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED . 18 A

	Concurrence of CDRH, Office of Device Evaluation/ODE)
	(Division Sign-Off)
	Division of General, Restorative,
	and Neurological Devices
Prescription Use X
510(k) Number	K070082 Over-The-Counter Use
Vertebration Inc.

oration, Inc. Proprietary and Confidential Information

1/08/2007

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.