The Spinal USA VBR System is intended for use in the thoracic and/or thoracolumbar spine (T1-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 Spinal USA VBR System is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column

The Spinal USA VBR System is intended to be used with supplemental spinal fixation systems that have been cleared 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). In addition, the Spinal USA VBR System is intended for use with bone graft.

Device Description

The Spinal USA VBR System is a vertebral body replacement device that is implanted into the vertebral body space to improve stability of the spine. The system consists of a straight, curved, round, and trapezoidal implants. The various implants via shallsin, curved, curved, curved, the individual patient anatomy. All components are made from medical grade titanium or titanium or titanium or titanium or titanium or titanium or titanium or titanium or tit alloy described by such standards as ASTM F136 or ISO5832-3. The products are supplied clean and "NON-STERILE".

AI/ML Overview

This document is a 510(k) summary for the Spinal USA VBR System, a vertebral body replacement device. It focuses on demonstrating substantial equivalence to previously cleared devices rather than a detailed performance study with acceptance criteria in the typical sense of AI/software devices. Therefore, many of the requested categories are not applicable or cannot be extracted directly from this type of regulatory submission.

Here's a breakdown of the information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

This type of information is not available in the provided 510(k) summary. For medical devices seeking 510(k) clearance, the primary "acceptance criterion" is often demonstrating substantial equivalence to a predicate device. This is typically shown through:

Materials testing: Ensuring the device materials meet established standards (e.g., biocompatibility, mechanical properties).
Mechanical testing: Demonstrating that the device performs equivalently or better than predicate devices under specified biomechanical loads.
Design similarities: Highlighting that the device's design and intended use are similar to predicate devices.

The document states: "Testing in accordance with ASTM F2077-03 'Test Methods for Intervertebral Body Fusion Devices' of the Spinal USA VBR System demonstrates that the device is substantially equivalent to the Novel VBR Spinal System (K042201), Lanx VBR System (K052384), Depuy Acromed Stackable Cage (K990148), Quantum VBR Quantum Orthopedics(K050449), PEEK Tetris Signus Medical (K031757), CO VBR Scient X(K050348), Ellys and Aurys VBR Scient'X (K033109)."

This statement implies that the device met the performance requirements outlined in ASTM F2077-03, which serves as the "acceptance criteria" for mechanical performance, to establish substantial equivalence. However, the specific quantitative criteria (e.g., "withstanding X N of compression for Y cycles") and the exact performance results are not reported in this summary.

Acceptance Criteria (Implied)	Reported Device Performance
Conformance to ASTM F2077-03 "Test Methods for Intervertebral Body Fusion Devices" for mechanical performance relative to predicate devices.	The device "demonstrates that the device is substantially equivalent" to listed predicate devices through testing in accordance with ASTM F2077-03. Specific numerical performance data are not provided in this summary.
Materials meeting medical-grade standards (e.g., ASTM F136 or ISO5832-3).	All components are made from medical grade titanium or titanium alloy described by such standards as ASTM F136 or ISO5832-3.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not applicable in the context of a mechanical device 510(k) submission like this. The "test set" here refers to the physical devices undergoing mechanical and material testing, not a dataset of patient images or clinical outcomes. Data provenance for such mechanical testing typically relates to the lab where tests were conducted, not country of origin of patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is not applicable. Ground truth in the context of mechanical device testing refers to established engineering specifications, material standards, and biomechanical principles, not expert medical opinion on images or clinical cases.

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

This is not applicable for mechanical device testing.

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

This is not applicable. This document describes a physical medical implant, not an AI or diagnostic imaging device.

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

This is not applicable. This document describes a physical medical implant, not an AI or diagnostic imaging device.

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

The "ground truth" for this device's performance relies on established engineering standards, material specifications, and biomechanical testing protocols. The device's ability to maintain spinal stability and integrity, as well as its material properties, are objectively measured against these predefined standards. For instance, the ASTM F2077-03 standard specifies methods for evaluating intervertebral body fusion devices, and conformance to this standard serves as a form of "ground truth" for mechanical performance.

8. The sample size for the training set

This is not applicable. There is no "training set" in the context of a 510(k) submission for a mechanical implant.

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

This is not applicable. There is no "training set" in the context of a 510(k) submission for a mechanical implant.

Summary

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510 (k) Summary of Safety and Effectiveness

Date Summary Prepared:	June 20, 2006
Submitter Information:	Spinal USA644 Lakeland East Drive Suite AFlowood, MS 39047
Contact Name:	Jeffrey Johnson
Phone:	601-420-4244
Fax:	601-420-5501
E-mail:	jeff@spinalusa.com
Device Trade Name:	Spinal USA VBR System
Common Name:	Vertebral Body Replacement
Regulatory Number:	888.3060
Classification:	Class II
Product Code:	MOP

INTENDED USE:

The Spinal USA VBR System is intended for use in the thoracic and/or thoracolumbar spine (T1-L.5) 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 Spinal USA VBR System is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column. The Spinal USA VBR System is intended to be used with supplemental spinal fixation systems that have been cleared 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). In addition, the Spinal USA VBR System is intended for use with bone graw a

DEVICE DESCRIPTION:

EQUIVALENT DEVICE:

Testing in accordance with ASTM F2077-03 "Test Methods for Intervertebral Body Fusion Devices" of the Spinal USA VBR System demonstrates that the device is substantially equivalent to the Novel VBR Spinal System (K042201), Lanx VBR System (K052384), Depuy Acromed Stackable Cage (K990148), Quantum VBR Quantum Orthopedics(K050449), PEEK Tetris Signus Medical (K031757), CO VBR Scient X(K050348), Ellys and Aurys VBR Scient'X (K033109).

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Image /page/1/Picture/1 description: The image shows the logo for the United States Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of a caduceus, which is a symbol often associated with medicine and healthcare. The caduceus in the logo is depicted with three intertwined snakes and a staff.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 1 5 2006

Spinal USA % Mr. Jeffrey Johnson Manager, Regulatory Affairs 644 Lakeland East Drive, Suite A Flowood. Mississippi 39232

Re: K061752

Trade/Device Name: Spinal USA VBR System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: MQP Dated: June 20, 2006 Received: June 21, 2006

Dear Mr. Johnson:

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. This

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Page 2 – Mr. Jeffrey Johnson

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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Barbara Buell

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

Enclosure

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Indications for Use

510(k) Number (if known):

Device Name: Spinal USA VBR System

Indications for Use:

The Spinal USA VBR System is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column

Prescription Use × (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Василе Виели

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

510(k) Number_KOG | 752

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.