INTERPLATE VBR SYSTEM

K070316 · Rsb Spine, LLC · MQP · Apr 19, 2007 · Orthopedic

Device Facts

• Record ID: K070316
• Device Name: INTERPLATE VBR SYSTEM
• Applicant: Rsb Spine, LLC
• Product Code: MQP · Orthopedic
• Decision Date: Apr 19, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The InterPlate™ VBR device is indicated for the replacement of a complete or partial vertebrectomy, when used with a bone graft material to facilitate fusion. It is designed to restore biomechanical integrity of the thoracic and lumbar spine, from T1 to L5, which has been damaged due to a collapsed or unstable vertebral body resulting from a tumor or traumatic injury.

Device Story

InterPlate™ VBR System is a spinal intervertebral body fixation orthosis; consists of plates, bone screws, and screw covers. Used by surgeons in clinical settings to restore biomechanical integrity of thoracic and lumbar spine (T1-L5) following vertebrectomy. Device components are implanted to stabilize the spine; bone graft is used in conjunction to facilitate fusion. System accommodates individual patient anatomy through various plate sizes and matched screw covers.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Components manufactured from Ti-6Al-4V titanium alloy (ASTM F136). System includes plates, bone screws, and screw covers. Mechanical fixation device.

Indications for Use

Indicated for patients requiring complete or partial vertebrectomy in the thoracic and lumbar spine (T1-L5) due to vertebral body collapse or instability caused by tumor or trauma. Must be used with bone graft to facilitate fusion.

Regulatory Classification

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.

Submission Summary (Full Text)

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Tab IV 510(k) Summary

K070316

| Sponsor: | RSB Spine, LLC<br>3030 Superior Ave., Suite 703<br>Cleveland, OH 44114 | APR 19 2007 |
|-----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| Contact Person: | James M. Moran, D. Eng.<br>Vice President of Engineering and Chief Technical Officer | |
| Proprietary Trade<br>Name: | InterPlate™ VBR System | |
| Classification Name | 888.3060 - Spinal Intervertebral Body Fixation Orthosis | |
| Device Product<br>Code: | MQP | |
| Device Description: | The InterPlate™ VBR consists of plates, bone screws and screw covers. Various<br>plate sizes are available to accommodate individual patient anatomy and graft<br>material size. Screw covers are individually matched to the plate size. | |
| Intended Use: | The InterPlate™ VBR device is indicated for the replacement of a complete or<br>partial vertebrectomy, when used with a bone graft material to facilitate fusion. It<br>is designed to restore biomechanical integrity of the thoracic and lumbar spine,<br>from T1 to L5, which has been damaged due to a collapsed or unstable vertebral<br>body resulting from a tumor or traumatic injury. | |
| Materials: | The InterPlate™ VBR System components are manufactured from Ti-6Al-4V<br>titanium alloy (ASTM F136). | |
| Substantial<br>Equivalence: | Documentation was provided which demonstrated the InterPlate™ VBR System<br>to be substantially equivalent to previously cleared devices. The substantial<br>equivalence is based upon equivalence in intended use, indications, anatomic<br>sites, performance and material of manufacture. | |

1. September 19.

|

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

RSB Spine, LLC % Mr. James Moran Vice President, Engineering 2530 Superior Avenue, Suite 703 Cleveland, Ohio 44114

APR 1 9 2007

K070316 Trade/Device Name: InterPlate™ VBR System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: MOP Dated: January 29, 2007 Received: February 1, 2007

Dear Mr. Moran:

Re:

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 - Mr. James Moran

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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Darban Buell

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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## Tab II Indications for Use

KS70316 510(k) Number:

## Device Name: InterPlate TM Vertebral Body Replacement (VBR) System

Indications for Use:

The InterPlate™ VBR device is indicated for the replacement of a complete or partial vertebrectomy, when used with a bone graft to facilitate fusion. It is designed to restore biomechanical integrity of the thoracic and lumbar spine, from T1 to L5, which has been damaged due to a collapsed or unstable vertebral body resulting from a tumor or traumatic injury.

Prescription Use X (Per 21 CFR 801.109)

OR

Over-the-Counter Use

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Arslane Mneimneh
Division Sign Off

Division of General, Restorative, and Neurological Devices

510(k) Number K070316

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