SPINAL USA INTERBODY FUSION DEVICE

K080314 · Spinal USA · MAX · May 13, 2008 · Orthopedic

Device Facts

• Record ID: K080314
• Device Name: SPINAL USA INTERBODY FUSION DEVICE
• Applicant: Spinal USA
• Product Code: MAX · Orthopedic
• Decision Date: May 13, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Spinal USA Interbody Fusion Device is indicated for intervertebral body fusion of the spine in skeletally mature patients. The device system is designed for use with autograft to facilitate fusion. One device is used per intervertebral space. The Spinal USA Interbody Fusion Device ACIF System is intended for use in the cervical spine, from C3 to T1, for the treatment of cervical disc disease defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The cervical device is to be used with supplemental fixation and autogenous bone graft. Patients should have at least six weeks of non-operative treatment prior to treatment with an intervertebral fusion device. The Spinal USA Interbody Fusion Device ALIF, PLIF, TLIF System are intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The lumbar device is to be used with supplemental fixation and autogenuos bone graft. Patients should have at least six months of nonoperative treatment prior to treatment with a lumbar intervertebral fusion device. The Spinal USA Interbody Fusion Device RPIF System is intended to be used only in anterior procedures in which an ALIF device of the same height is implanted. The RPIF device is not meant for stand alone use.

Device Story

Spinal USA Interbody Fusion Device consists of implants (ACIF, ALIF, PLIF, TLIF, RPIF) and bone screws; designed to accommodate patient anatomy and graft material. Implants placed in intervertebral space to facilitate fusion; used with autograft and supplemental fixation. Operated by surgeons in clinical/OR settings. Provides structural support to spinal column; promotes fusion in patients with degenerative disc disease or discogenic pain. Benefits include stabilization of spinal segments and potential reduction of pain.

Clinical Evidence

Bench testing only.

Technological Characteristics

Constructed from Ti-6Al-4V titanium alloy (ASTM F136). System includes various widths, heights, and lengths of implants and bone screws. Supplied non-sterile.

Indications for Use

Indicated for intervertebral body fusion in skeletally mature patients. ACIF system: cervical spine (C3-T1) for discogenic neck pain/degeneration; requires 6 weeks non-operative treatment. ALIF/PLIF/TLIF systems: lumbar spine (L2-S1) for degenerative disc disease with up to Grade I spondylolisthesis; requires 6 months non-operative treatment. RPIF system: anterior procedures as adjunct to ALIF. All systems require autograft and supplemental fixation.

Regulatory Classification

Identification

An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.

Special Controls

*Classification.* (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval. (c) *Date premarket approval application (PMA) or notice of product development protocol (PDP) is required.* Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.

Submission Summary (Full Text)

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## 510 (k) Summary of Safety and Effectiveness

# FDA CDRH DMC

| Date Summary Prepared: | February 1, 2008 | MAY - 8 2008 |
|--------------------------------------------------------|-----------------------------------------------------------------------|--------------|
| Submitter Information: | Spinal USA<br>644 Lakeland East Drive Suite A<br>Flowood, MS 39232 | Received |
| Contact Name:<br>Phone:<br>Fax:<br>E-mail: | Jeffrey Johnson<br>601-420-4244<br>601-420-5501<br>[e-mail] | MAY 13 2008 |
| Device Trade Name: | Spinal USA Intervertebral Body Fusion Device | |
| Common Name: | Intervertebral Body Fusion Device | |
| Regulatory Number:<br>Classification:<br>Product Code: | 888.3080, 888.3060<br>Class II<br>MAX, ODP, KWQ | |

### INTENDED USE:

The Spinal USA Interbody Fusion Device is indicated for intervertebral body fusion of the spine in skeletally mature patients. The device system is designed for use with autograft to facilitate fusion. One device is used per intervertebral space.

The Spinal USA Interbody Fusion Device ACIF System is intended for use in the cervical spine, from C3 to T1, for the treatment of cervical disc disease defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The cervical device is to be used with supplemental fixation and autogenous bone graft. Patients should have at least six weeks of non-operative treatment prior to treatment with an intervertebral fusion device.

The Spinal USA Interbody Fusion Device ALIF, PLIF, TLIF System are intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The lumbar device is to be used with supplemental fixation and autogenuos bone graft. Patients should have at least six months of nonoperative treatment prior to treatment with a lumbar intervertebral fusion device.

The Spinal USA Interbody Fusion Device RPIF System is intended to be used only in anterior procedures in which an ALIF device of the same height is implanted. The RPIF device is not meant for stand alone use.

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Körüziv

### DEVICE DESCRIPTION:

The Spinal USA Interbody Fusion Device consists of implants with various widths, heights, lengths and bone screws to accommodate individual patient anatomy and graft material size. All components are manufactured from Ti-6Al-4V titanium alloy (ASTM F136). The products are supplied clean and "NON-STERILE".

### EQUIVALENT DEVICE:

Documentation was provided which demonstrated the Spinal USA Interbody Fusion Device to be substantially equivalent to previously cleared devices. The substantial equivalence is based upon equivalence in intended use, indications, anatomic sites, performance and material of manufacture.

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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 its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" arranged in a circular pattern around the eagle. The eagle is depicted in a simple, abstract style with thick, black lines. The text is in a smaller font size and is also in black.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Spinal USA % Mr. Jeffrey Johnson 644 Lakeland East Drive Suite A Flowood, MS 39232

MAY 1 3 2008

Re: K080314 Trade/Device Name: Spinal USA Interbody Fusion Device Regulation Number: 21 CFR 888.3080 Regulation Name: Spinal intervertebral body fusion device Regulatory Class: II Product Code: MAX, ODP, KWQ Dated: May 7, 2008 Received: May 8, 2008

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. Jeffrey 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 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 W. Miller

- . 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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# Indications for Use

510(k) Number (if known);

Device Name: Spinal USA Interbody Fusion Device

Indications for Use:

The Spinal USA Interbody Fusion Device is indicated for intervertebral body fusion of the spine in skeletally mature patients. The device system is designed for use with autograft to facilitate fusion. One device is used per intervertebral space.

The Spinal USA Interbody Fusion Device ACIF System is intended for use in the cervical spine, from C3 to T1, for the treatment of cervical disc disease defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The cervical device is to be used with supplemental fixation and autogenous bone graft. Patients should have at least six weeks of non-operative treatment prior to treatment with an intervertebral fusion device.

The Spinal USA Interbody Fusion Device ALIF, PLIF, TLIF System are intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The lumbar device is to be used with supplemental fixation and autogenuos bone graft. Patients should have at least six months of non-operative treatment prior to treatment with a lumbar intervertebral fusion device.

The Spinal USA Interbody Device RPIF System is intended to be used only in anterior procedures in which an ALIF device of the same height is implanted. The RPIF device is not meant for stand alone use.

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 Evalu

(Division Sign-Off)

Division of General, Restorative.

page i of 1 and Neurological Devices

510(k) Number K080314