PLATEAU SPACER SYSTEM

K080411 · Life Spine · MAX · May 15, 2008 · Orthopedic

Device Facts

• Record ID: K080411
• Device Name: PLATEAU SPACER SYSTEM
• Applicant: Life Spine
• Product Code: MAX · Orthopedic
• Decision Date: May 15, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Plateau Spacer System is intended for spinal fusion procedures in skeletally mature patients with degenerative disease (DDD) at one or two contiguous levels (L2-S1). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). It is to be used in patients who have had at least six months of non-operative treatment. This device is intended to be used with autogenous bone graft and a supplemental internal spinal fixation system that is cleared for use in the lumbosacral spine.

Device Story

Intervertebral body fusion device; hollow PEEK-OPTIMA LT1 implant with titanium markers; filled with autogenous bone graft to promote fusion. Superior/inferior surfaces feature teeth to interface with vertebral endplates; prevents rotation/migration. Used in spinal fusion procedures by surgeons; requires supplemental internal spinal fixation system. Available in various sizes/footprints to accommodate patient anatomy/pathology.

Clinical Evidence

Bench testing only; biomechanical testing conducted in accordance with ASTM standards to demonstrate substantial equivalence.

Technological Characteristics

Materials: PEEK-OPTIMA LT1 with titanium markers. Design: Hollow intervertebral spacer with teeth on superior/inferior surfaces for endplate fixation. Dimensions: Various sizes/footprints. Energy source: None (mechanical).

Indications for Use

Indicated for skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels (L2-S1), including those with up to Grade 1 spondylolisthesis, who have failed at least six months of non-operative treatment.

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 PLATEAU® Spacer System

# MAY 1 5 2008

| Submitted By: | Life Spine<br>2401 W. Hassell Road, Suite 1535<br>Hoffman Estates, IL 60169<br>Telephone: [phone]<br>Fax: [phone] |
|-----------------|-----------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Contact: | Rebecca Brooks<br>Life Spine<br>2401 W. Hassell Road, Suite 1535<br>Hoffman Estates, IL 60169<br>Telephone: [phone]<br>Fax: [phone] |
| Date Prepared: | February 14, 2008 |
| Trade Name: | PLATEAU® Spacer System |
| Common Name: | Intervertebral Body Fusion Device |
| Classification: | MAX, 21 CFR 888.3080, Class II |

### Device Description:

The Plateau Spacer System is intended to serve as an intervertebral body fusion device. The implant is available in a range of sizes and footprints to suit the individual pathology and anatomical conditions of the patient. It is fabricated and manufactured from either analonical considered one (PEEK-OPTIMA LT1) with titanium markers. The implant is hollow to I oryeneredier with bone graft to help promote intervertebral body fusion. The superior and inferior surfaces have teeth to as in the interface with the vertebral endplates to prevent rotation and/or migration.

## Intended Use of the Device:

The Plateau Spacer System is intended for spinal fusion procedures in skeletally mature The Hatcad Spacer of themsee (DDD) at one or two contiguous levels (12-51). DDD is defined as back pain of discogenies origin with degeneration of the disc confirmed by history Is delined as back pun of ensorgane exgin well as also have up to Grade 1 spondylolisthesis at the involved level(s). It is to be used in patients who have had at least six months of non-operative treatment. This device is intended to be used with autogenous bone graft and a supplemental internal spinal fixation system that is cleared for use in the lumbosacral spine.

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K080411
Page 2 of 2

#### Performance Data:

r erormance Data.
Biomechanical testing in accordance with ASTM standards was conducted to demonstrate substantial equivalence to the predicate intervertebral body fusion devices.

#### Substantial Equivalence:

The Plateau Spacer System was shown to be substantially equivalent to previously cleared devices in indications for use, design, function, and materials used.

The first the contraction of the contribution of the comments of the comments of

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Life Spine % Ms. Rebecca Brooks 2401 W. Hassell Road Suite 1535 Hoffman Estates, IL 60169

MAY 1 5 2008

Re: K080411

> Trade/Device Name: PLATEAUTM Spacer System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: II Product Code: MAX Dated: February 14, 2008 Received: February 15, 2008

Dear Ms. Brooks:

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 - Ms. Rebecca Brooks

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 Millerson

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: PLATEAU® Spacer System

The Plateau Spacer System is intended for spinal fusion procedures in skeletally mature patients with degenerative disease (DDD) at one or two contiguous levels (L2-S1). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). It is to be used in patients who have had at least six months of non-operative treatment. This device is intended to be used with autogenous bone graft and a supplemental internal spinal fixation system that is cleared for use in the lumbosacral spine.

Prescription Use x (Part 21 CFR 801 Subpart D) And/Or

Over-the-Counter Use (21 CFR 807 Subpart C)

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

Nailre Bal fis mam

Division of General, Restorative, and Neurological Devices

510(k) Number.