MODIFICATION TO SPINAL USA VBR SYSTEM

K070922 · Spinal USA · KWQ · Sep 19, 2007 · Orthopedic

Device Facts

• Record ID: K070922
• Device Name: MODIFICATION TO SPINAL USA VBR SYSTEM
• Applicant: Spinal USA
• Product Code: KWQ · Orthopedic
• Decision Date: Sep 19, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Spinal USA Anterior Lumbar Plate System is intended for use as an anteriorly placed supplemental fixation device via the lateral or anterolateral surgical apove the bifurcation of the great vessel or via the anterior surgical approach, below the bifurcation of the great vessels. The device is intended as a temporary fixation device until fusion is achieved. The Spinal USA Anterior Lumbar Plate System is intended for anterior lumbar (L1-S1) fixation for the following indications: degenerative disc disease (DDD), defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma (i.e., fracture or dislocation), deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion,

Device Story

Spinal USA Anterior Lumbar Plate System is a supplemental fixation device for anterior lumbar (L1-S1) spine. System comprises titanium/titanium alloy plates and screws; features preassembled rivet locking mechanism. Used by surgeons in clinical settings to stabilize vertebral bodies during biological spinal fusion process. Device provides temporary fixation until fusion achieved. Benefits include structural support for spinal segments affected by DDD, trauma, or deformity.

Clinical Evidence

Bench testing only.

Technological Characteristics

Medical grade titanium or titanium alloy (ASTM F136 or ISO 5832-3). System includes plates (21mm, 23mm) and screws (5.0mm, 5.5mm diameters; 25mm-35mm lengths). Features preassembled rivet locking mechanism. Supplied non-sterile.

Indications for Use

Indicated for patients requiring anterior lumbar (L1-S1) fixation for degenerative disc disease, spondylolisthesis, trauma (fracture/dislocation), spinal deformities (scoliosis, kyphosis, lordosis), tumor, pseudoarthrosis, or failed previous 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.

Predicate Devices

• Synthes Anterior Tension Band System (K022791)
• Aegis Anterior Lumbar Plate System (K052546)
• Pyramid Anterior Plate Fixation System (K013665)
• UnityLX Anterolateral Lumbar Plate System (K061229)
• Trinica Anterior Lumbar Plate System (K061353)

Submission Summary (Full Text)

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## 510 (k) Summary of Safety and Effectiveness

| Date Summary Prepared: | March 29, 2007 |
|--------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter Information: | Spinal USA<br>644 Lakeland East Drive Suite A<br>Flowood, MS 39047 |
| Contact Name:<br>Phone:<br>Fax:<br>E-mail: | Jeffrey Johnson<br>601-420-4244<br>601-420-5501<br>[e-mail] |
| Device Trade Name: | Spinal USA Anterior Lumbar Plate System |
| Common Name: | Spinal Fixation System |
| Regulatory Number: | 888.3060 |
| Classification: | Class II |
| Product Code: | KWQ |
| Predicate Devices: | Synthes Anterior Tension Band System (K022791)<br>Aegis Anterior Lumbar Plate System (K052546)<br>Pyramid Anterior Plate Fixation System (K013665)<br>UnityLX Anterolateral Lumbar Plate System (K061229)<br>Trinica Anterior Lumbar Plate System (K061353) |

### INTENDED USE:

The Spinal USA Anterior Lumbar Plate System is intended for use as an anteriorly placed supplemental fixation device via the lateral or anterolateral surgical apove the bifurcation of the great vessel or via the anterior surgical approach, below the bifurcation of the great vessels. The device is intended as a temporary fixation device until fusion is achieved. The Spinal USA Anterior Lumbar Plate System is intended for anterior lumbar (L1-S1) fixation for the following indications: degenerative disc disease (DDD), defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma (i.e., fracture or dislocation), deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion,

### DEVICE DESCRIPTION:

The Spinal USA Anterior Lumbar Plate System consists of a range of plate and screw sizes. The plates come in sizes of: 21mm, 23mm, The screws come in 5.0mm and 5.5mm diameters and the screw lengths are 25mm, 30mm, 35mm. The plates locking mechanism is a preassembled rivet that is attached to every plate. The plates attach to the anterior or anterolateral aspect of the vertebral body of the lumbar/lumbosacral spine (levels L1-S1) and provide stabilization to permit the biological process of spinal fusion to occur. All components are made from medical grade titanium or titanium alloy described by such standards as ASTM F136 or ISO5832-3. The products are supplied clean and "NON-STERILE".

#### EQUIVALENT DEVICE:

Documentation was provided which demonstrated the Spinal USA Anterior Lumbar Plate System to be substantially equivalent to its predicate devices with respect to performance data, intended use and indications, and basic principles of operation. As demonstrated by performance data, these technological differences do not present any new issues of safety or effectiveness.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines forming its body and head. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 1 9 2007

Spinal USA % Mr. Jeffery Johnson Manager, Regulatory Affairs

644 Lakeland East Drive, Suite A Flowood, Mississippi 39232

Re: K070922 Trade/Device Name: Spinal USA Anterior Lumbar Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: KWQ Dated: March 29, 2007 Received: July 18, 2007

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.

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Page 2 - Mr. Jeffery Johnson

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 I v(L) marketed predicate device results in a classification for your device and thus, permits your levice 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 antoll-free number [phone] or [phone] or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Barbara Buehrn

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

Enclosure

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# Indications for Use

510(k) Number : K070922

Device Name: Spinal USA Anterior Lumbar Plate System

Indications for Use:

The Spinal USA Anterior Lumbar Plate System is intended for use as an anteriorly placed supplemental fixation device via the lateral or anterolater al surgicul approach above the bifurcation of the great vessel or via the exterior surgical approach, below the bifurcation of the great vessels. The device is intended as a temperary fixation device until fusion is achieved. The Spinal USA Anterior Lumbar Plate System is intended for anterior lumbar (L1-S1) fixation for the following indications: degreerative discase (DDD), defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma (i.e., fracture and dislocation), deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.

Prescription Use X (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)

Barbara ImehdDA
Division Sign-Off

Division of General, Restorative, and Neurological Devices

**510(k) Number** K070922