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 XYcor™ Spinal Implant is intended for use with bone graft and supplemental internal fixation for vertebral body replacement. The supplemental internal fixation systems that may be used with the XYcor™ 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 screwrod/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.

The XY cor™ Spinal Implant is not intended to be used as a stand-alone device. It must be used with supplemental internal spinal fixation systems that have been cleared for use in the lumbar spine (i.e., facet screw fixation systems, facet compression devices, and posterior pedicle screw and rod systems).

Device Description

The XY cor™ Spinal Implant is a spinal implant fabricated from titanium that can be used as a vertebral body replacement device or an intervertebral body fusion device. The XYcor™ Spinal Implant deploys with a self-locking mechanism. The footprint of XYcor™ Spinal Implant V2-25 before and after deployment is of comparable size and shape to the other sizes of the XY cor™ implant.

AI/ML Overview

The provided text describes a 510(k) submission for the XYcor™ Spinal Implant, focusing heavily on its intended use, design, and claiming substantial equivalence to a previously cleared device. The "Performance Data" section specifically mentions mechanical testing.

Here's an analysis of the acceptance criteria and study information based only on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied)	Reported Device Performance
Sufficient strength for static compressive loading	Demonstrated sufficient strength for static compressive loading modes.
Sufficient strength for dynamic compressive loading	Demonstrated sufficient strength for dynamic compressive loading modes.
Sufficient strength for torsional loading	Demonstrated sufficient strength for torsional loading modes.
Resistance to subsidence	Demonstrated resistance to subsidence.
Resistance to expulsion	Demonstrated resistance to expulsion.
Safety and effectiveness	The results did not raise any issues on the safety or effectiveness of the device.

Explanation: The document does not explicitly state numerical or specific pass/fail criteria for the mechanical tests (e.g., "must withstand X N of compression"). However, it does report that the device "demonstrated sufficient strength" and "resistance," implying these were the criteria evaluated. The final statement regarding safety and effectiveness acts as an overarching acceptance criterion.

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

Sample Size: Not specified. The document only states "Mechanical testing was performed on the XY cor™ Spinal Implant V2-25." It does not provide the number of devices tested.
Data Provenance: The document does not specify the country of origin of the data. Given it's a 510(k) submission to the FDA, it can be inferred the data was generated to meet US regulatory requirements, but the physical location of the testing is not stated. The study is prospective in the sense that the testing was conducted specifically to support this regulatory submission for the V2-25 small size implant.

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

This information is not applicable as the study described is a mechanical testing study, not a clinical study involving expert interpretation of data (e.g., imaging). The "ground truth" for mechanical testing is based on engineered specifications and physical measurements, not expert consensus.

4. Adjudication Method for the Test Set

This information is not applicable for the same reasons as point 3. Mechanical test results do not typically involve adjudication by experts in the way clinical data might. The measured outcomes are objective physical properties.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted or described in the provided text. The submission focuses on mechanical testing.

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

This information is not applicable. The device is a physical spinal implant, not an algorithm or AI software. Therefore, the concept of "standalone (algorithm only)" performance does not apply.

7. Type of Ground Truth Used

The ground truth for this device's performance is based on mechanical engineering principles and measurements. The "sufficient strength" and "resistance" claims are derived from objective physical testing against established biomechanical standards and possibly comparison to the predicate device's performance.

8. Sample Size for the Training Set

This information is not applicable. There is no mention of a "training set" because the device is a physical implant, not an AI/machine learning model.

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

This information is not applicable for the same reasons as point 8.

Summary

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

JAN - 9 2009

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

510(k) Owner:

Vertebration, Inc. 3375 Brentwood Court Powell, OH 43065 Phone: (614) 437-2027 Facsimile: (614) 437-2034

Contact person:

Barbara S. Fant, Pharm.D. Clinical Research Consultants, Inc. 310 Terrace Avenue Suite 201 Cincinnati, OH 45220 (513) 961-8200 Phone: Facsimile: (513) 961-2858

August 22, 2008 Date:

XY cor™ Spinal Implant for Minimally Invasive Spinal Surgery Trade Name:

Vertebral body replacement device Common name:

Classification Name: Spinal Intervertebral body fixation orthosis 21 CFR 888.3060,

Product Code: MOP

Identification of a Legally Marketed Predicate Device

As a Vertebral Body Replacement Device, the XY cor™ Spinal Implant V2-25 small size is substantially equivalent to the XYcor™ standard and large sizes marketed by Vertebration, 510(k) Premarket Notification Number: K070082, FDA Product Code MQP.

General Description

Intended Use

Page 1 of 2

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

The XYcor™ 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.

Performance Data

Mechanical testing was performed on the XY cor™ Spinal Implant V2-25 and the results are presented. The XYcor™ Spinal Implant V2-25 demonstrated sufficient strength for static and dynamic compressive and torsional loading modes and resistance to subsidence and expulsion. Mechanical testing performed on the XY cor™ Spinal Implant supports its use as a vertebral body replacement device.. The results did not raise any issues on the safety or effectiveness of the device.

Basis of Substantial Equivalence

The XY cor™ Spinal ImplantV2-25 is substantially equivalent to the other sizes of the XYcor™ Spinal Implant manufactured by Vertebration under 510(k) Premarket Notification Number K070082, FDA Product Code MQP, and regulation 21CFR§888.3060 (spinal intervertebral body fixation orthosis) in material, intended use, basic design concept, size of the footprint, and biomechanical properties.

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

DEPARTMENT OF HEALTH & HUMAN SERVICES

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 legs, representing the department's commitment to health, human services, and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Vertebration, Inc. % Barbara S. Fant, Pharm.D. Clinical Research Consultants, Inc. 310 Terrace Avenue, Suite 201 Cincinnati, OH 45220

Re: K082466

Trade/Device Name: XY cor Spinal Implant Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: MQP Dated: January 2, 2009 Received: January 5, 2009

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.

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

Page 2 - Barbara S. Fant, Pharm.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 the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark McMullen

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

Enclosure

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

4. Indications for Use Statement

510(k) Number (if known): K082466

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-LS) to replace a collapsed, damaged, or unstable vertebral body resected or excised (i.e., partial or total vertebrectory procedures) due to tumor or trauma (i.e., fracture). The XY corPM Spinal implant is designed to restore the biomechanical integrity of the anterior, THC A respired to 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 for vertebral body replacement. The supplemental interpal fixation systems that may be used with the XY cor™ Spinal Implant include Medtronic Sofamor Danek TSRH 3D, DePuy Spine Expedium or Monarch pedicle screw fraation 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 smiling smi-rigid or flexible rod-screw systems.

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

Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use Over-The-Counter Use

(Division Sign-Off)
Division of General, Restorati

Division of General, Restorative, and Neurological Devices

510(k) Number L082461

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.