VERTEBRON VBR SYSTEM

K073502 · Vertebron, Inc. · MQP · Mar 24, 2008 · Orthopedic

Device Facts

• Record ID: K073502
• Device Name: VERTEBRON VBR SYSTEM
• Applicant: Vertebron, Inc.
• Product Code: MQP · Orthopedic
• Decision Date: Mar 24, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The VERTEBRON Interbody Fusion System is indicated for use with autogenous bone graft in skeletally mature patients with degenerative disc disease ("DDD") at one or two contiguous spinal levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six months of non-operative treatment. These DDD patients may have had a previous non-fusion spinal surgery at the involved spinal level(s), and may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). The VERTEBRON Interbody Fusion System is implanted via an anterior or posterior approach and is to be combined with cleared supplemental fixation systems include, such as the VERTEBRON PSS Pedicle Screw System.

Device Story

Intervertebral body fusion device; consists of PEEK or titanium alloy components in various heights/angles/configurations. Hollow chamber allows autogenous bone graft packing; provides column support. Features surface teeth for stability; tantalum wire markers for radiographic visualization. Implanted via anterior or posterior approach; requires supplemental fixation (e.g., pedicle screw system). Used by surgeons in clinical settings to facilitate spinal fusion in DDD patients.

Clinical Evidence

Bench testing only. Performance evaluated per ASTM F2077-03 (interbody fusion device test methods) and ASTM F2267 (load-induced subsidence). No clinical data provided.

Technological Characteristics

Materials: PEEK (ASTM F2026), Titanium alloy (ASTM F136), Tantalum (ASTM F560). Form factor: Various heights/angles/configurations with surface teeth. Energy source: None (mechanical). Connectivity: None. Sterilization: Not specified.

Indications for Use

Indicated for skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD defined as discogenic back pain with radiographic confirmation and 6 months failed non-operative treatment. Includes patients with prior non-fusion surgery at involved levels and up to Grade 1 spondylolisthesis or retrolisthesis.

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.

Predicate Devices

• Lanx (K073144)
• Globus Medical (K072970)
• Innovative Spine (K072120)
• Abbott Spine (K073202)

Submission Summary (Full Text)

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K073502

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- 3. 510(k) Summary or 510(k) Statement

| SUBMITTER: | MAR 2 4 2008<br>VERTEBRON Inc.<br>80 Hathaway Drive<br>Stratford, CT 06615<br>[phone] |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| CONTACT PERSON: | Luis Nesprido<br>Senior Manager Regulatory Affairs |
| DATE PREPARED: | September 10, 2007 |
| CLASSIFICATION NAME: | 21 CFR §888.3080 Intervertebral Body Fusion Device |
| COMMON NAME: | Intervertebral Body Fusion Device |
| PROPRIETARY NAME: | VERTEBRON Interbody Fusion System |
| PREDICATE DEVICES: | Lanx K073144<br>Globus Medical K072970<br>Innovative Spine K072120<br>Abbott Spine K073202 |
| DEVICE DESCRIPTION: | The VERTEBRON Interbody Fusion System consists of<br>various heights, angles and configurations (i.e., square.<br>rectangular D-shaped, etc.). The device is use singly or in<br>pairs to better approximate the anatomical variations<br>observed in different vertebral levels and/or patient<br>anatomy. |
| | The VERTEBRON Interbody Fusion System is comprised<br>of a variety of components fabricated and manufactured<br>from Polyetheretherketone (PEEK) as described by ASTM<br>2026. This material is utilized due to its radiolucent<br>properties, which aid the surgeon in determining if fusion in<br>the operative site has occurred. |
| | The VERTEBRON Interbody Fusion System has a hollow<br>chamber to permit packing with autogenous bone graft to<br>facilitate fusion, but is of sufficient strength to provide<br>column support even in the absence of fusion for<br>prolonged periods. The superior and inferior surfaces of<br>the construct have a pattern of teeth to provide increased<br>stability and to help prevent movement of the device.<br>Tantalum wire markers (ASTM F560) are inserted into the<br>components to give surgeons a visual aid in determining<br>the location of the implant, both inter and post-operatively. |

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K073502

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INTENDED USE: The VERTEBRON Interbody Fusion System is indicated for use with autogenous bone graft in skeletally mature patients with degenerative disc disease ("DDD") at one or two contiguous spinal levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six months of non-operative treatment. These DDD patients may have had a previous non-fusion spinal surgery at the involved spinal level(s), and may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s).

> The VERTEBRON Interbody Fusion System is implanted via an anterior or posterior approach and is to be combined with cleared supplemental fixation systems include, such as the VERTEBRON PSS Pedicle Screw System.

## The material used is PEEK ASTM F2026-07e1 Standard MATERIALS: Specification for Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications or titanium alloy (TI-6AI-4V) that conforms to ASTM F136 Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401) and ASTM F560 Standard Specification for Unalloyed Tantalum for Surgical Implant Applications.

## SUBSTANTIAL EQUIVALENCE:

Performance evaluation was conducted in accordance with ASTM F2077-03 - Test Methods for Interbody Fusion Devices and ASTM F2267 – Standard Test Methods for Measuring Load Induced Subsidence of an Interbody Fusion Device Under Static Axial Compression

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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 body and wings. The eagle faces right and is positioned within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 4 2008

Vertebron, Incorporated % Mr. Luis Nesprido Senior Manager, Regulatory Affairs 80 Hathaway Drive Stratford, CT 06615

K073502 Re: Trade/Device Name: Vertebron Interbody Fusion System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX

Dated: February 15, 2008 Received: February 21, 2008

Dear Mr. Nesprido:

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. Luis Nesprido

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 [phone]. 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 [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. 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 [phone] or [phone] or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark N. Millican

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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## 2. Indications for Use Statement

510(k) Number (if known):

Device Name:

VERTEBRON Interbody Fusion System

Indications For Use:

The VERTEBRON Interbody Fusion System is indicated for use with autogenous bone graft in skeletally mature patients with degenerative disc disease ("DDD") at one or two contiguous spinal levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six months of non-operative treatment. These DDD patients may have had a previous non-fusion spinal surgery at the involved spinal level(s), and may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s).

The VERTEBRON Interbody Fusion System is implanted via an anterior or posterior approach and is to be combined with cleared supplemental fixation systems, such as the VERTEBRON PSS Pedicle Screw System.

Prescription Use: × AND / OR (Per 21 CFR 801 Subpart D)

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

(Please do not write below this line - continue on another page if needed)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Juta

sion Sign-Of Division of General, Restorative, and Neurological Devices

**510(k) Number** K073502