TURBO PRIME IBD SYSTEM

K080058 · Spineselect, LLC · MAX · Apr 16, 2008 · Orthopedic

Device Facts

• Record ID: K080058
• Device Name: TURBO PRIME IBD SYSTEM
• Applicant: Spineselect, LLC
• Product Code: MAX · Orthopedic
• Decision Date: Apr 16, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Turbo Prime IBD (Interbody Device) System is indicated for use in skeletally mature patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies who have had at least six months of non-operative care for their DDD. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). It is indicated to be used with autograft bone.

Device Story

Turbo Prime IBD System is a spinal intervertebral fusion orthosis; consists of titanium alloy implants of various sizes and associated instrumentation. Used by surgeons in clinical settings to treat degenerative disc disease; implants placed in intervertebral space to facilitate fusion; requires autograft bone. Device provides structural support to spinal column; intended to alleviate discogenic back pain. No software or electronic components.

Clinical Evidence

Bench testing only.

Technological Characteristics

Implantable components manufactured from medical grade titanium alloy (Ti6A14V-ELI). System includes various implant sizes and associated instrumentation for spinal intervertebral fusion.

Indications for Use

Indicated for skeletally mature patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2-S1, including those with up to Grade I spondylolisthesis or retrolisthesis, who have failed at least six months of non-operative care. Must be used with autograft bone.

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.

Predicate Devices

• Inter Fix Threaded Fusion Device (P970015)
• Ray Threaded Fusion Cage (P950019)
• BAK Interbody Fusion Device (P950002)

Submission Summary (Full Text)

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SpineSelect

APR 1 6 2008

# 9. 510(k) Summary according to \$107.92(c)

| Contact: | Walter Eckman, M.D.<br>662-841-7585 | SpineSelect, LLC<br>408 Council Circle<br>PO Box 3660<br>Tupelo, MS 38803 |
|----------------------------|--------------------------------------------------|---------------------------------------------------------------------------|
| Trade Name: | Turbo Prime IBD System | |
| Classification Regulation: | 21 CFR §888.3080 Orthosis, intervertebral fusion | |
| Product Class: | Class II | |
| Product Codes: | MAX | |
| Panel Code: | 87 | |

## Indications for Use:

The Turbo Prime IBD (Interbody Device) System is indicated for use in skeletally mature patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by p& tient history and radiographic studies who have had at least six months of non-operative care for their DDD. T rese DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). It is indicated to be used with autograft bone.

### Device Description:

The Turbo Prime IBD System is comprised of a variety of implant sizes to accommodate various patient anatomy and pathology, and associated instrumentation. All implantable components are manufactured from medical grade titanium alloy (Ti6A14V-ELI).

# Predicate Device(s):

The Turbo Prime IBD System was shown to be substantially equivalent to previously cleared devices in:luding the Inter Fix Threaded Fusion Device (Sofamor Danek, P970015), the Ray Threaded Fusion Cage (Surg cal Dynamics, P950019) and the BAK Interbody Fusion Device (Spine Tech, P950002) and has the same indications for use, design, function, and materials used

### Performance Testing:

The pre-clinical testing performed indicated that the Turbo Prime IBD System is adequate for the intendiad use.

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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 consists of a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the emblem.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SpineSelect, LLC c/o Richard Jansen, Pharm.D. 13540 Guild Ave. Apple Valley, MN 55124

APR 1 6 2008

K080058 Re:

> Trade Name: TurboPrime IBD System Regulation Number(s): 21 CFR 888.3080 Regulation Names: Spinal intervertebral fusion orthosis Regulatory Class: Class II Product Code: MAX Dated: March 26, 2008 Received: March 27, 2008

Dear Dr. Jansen:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we 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 (PMA) application. You may, therefore, market the device, subject to the general controls provisions of the Act and the limitations described below. 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 - Richard Jansen, Pharm.D.

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 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 Wilkerson

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): K080058

Indications for Use:

The Turbo Prime IBD (Interbody Device) System is indicated for use in skeletally mature patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies who have had at least six months of nonoperative care for their DDD. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). It is indicated to be used with autograft bone.

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)

Neil RP Ogil-Franken

(Division Division of General, Restorative, and Neurological Devices

510(k) Number K080058