PLATEAU SPACER SYSTEM

K111835 · Life Spine, Inc. · ODP · Jul 19, 2011 · Orthopedic

Device Facts

• Record ID: K111835
• Device Name: PLATEAU SPACER SYSTEM
• Applicant: Life Spine, Inc.
• Product Code: ODP · Orthopedic
• Decision Date: Jul 19, 2011
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Small PLATEAU Spacer System is intended for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one disc level (C2-T1). DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. This device is intended to be used with autogenous bone graft and a supplemental internal spinal fixation system.

Device Story

Small PLATEAU Spacer System is an intervertebral body fusion device; used in spinal fusion procedures. Implant is hollow to permit packing with autogenous bone graft to promote fusion; superior and inferior surfaces feature teeth to interface with vertebral endplates to prevent rotation/migration. Available in various sizes/footprints to suit patient anatomy. Used by surgeons in clinical settings; requires supplemental internal spinal fixation. Device provides structural support during fusion process; benefits patients by stabilizing disc space in degenerative disc disease cases. Single-use only.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Manufactured from PEEK-OPTIMA LT1 (ASTM F2026) with 6-4 alloy titanium or unalloyed tantalum radiographic markers. Radiolucent material. Features teeth on superior/inferior surfaces. Single-use, non-sterile (implied by context of surgical implant).

Indications for Use

Indicated for skeletally mature patients with degenerative disc disease (DDD) at one disc level (C2-T1) requiring spinal fusion. DDD defined as discogenic pain with disc degeneration confirmed by history and radiographic studies. Must be used with autogenous bone graft and supplemental internal spinal 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.

Predicate Devices

• Plateau Spacer System (K093043)
• DePuy Bengal System (K081917)

Submission Summary (Full Text)

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JUL 1 9 2011

# 510(k) Summary Small PLATEAU® Spacer System

| Submitted By: | Life Spine, Inc.<br>2401 W. Hassell Road, Suite 1535<br>Hoffman Estates, IL 60169<br>Telephone: [phone]<br>Fax: [phone] |
|-------------------|--------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Contact: | Randy Lewis<br>Life Spine<br>2401 W. Hassell Road, Suite 1535<br>Hoffman Estates, IL 60169<br>Telephone: [phone]<br>Fax: [phone] |
| Date Prepared: | June 27th, 2011 |
| Trade Name: | Life Spine Small PLATEAU Spacer System |
| Common Name: | Intervertebral Body Fusion Device |
| Classification: | ODP, 21 CFR 888.3080, Class II |
| Predicate Device: | Plateau Spacer System (K093043), DePuy Bengal System (K081917) |

## Device Description:

The Small 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 Polyetheretherketone (PEEK-OPTIMA LT1) with radiographic markers. The implant is hollow to permit packing with autogenous bone graft to help promote intervertebral body fusion. The superior and inferior surfaces have teeth to assist in the interface with the vertebral endplates to prevent rotation and/or migration.

All implants are intended for single use only and should not be reused under any circumstances. Do not use any of the Small PLATEAU Spacer System components with components from any other system or manufacturer. The Small PLATEAU Spacer System components should never be reused under any circumstances.

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## Intended Use of the Device:

The Small PLATEAU Spacer System is intended for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one disc level (C2-T1). DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. This device is intended to be used with autogenous bone graft and a supplemental internal spinal fixation system.

### Material:

The Small PLATEAU Spacer System implants are manufactured according to ASTM F2026 from Polyetheretherketone (PEEK-OPTIMA LT1), which is a biocompatible material manufactured and supplied by Invibio, and either 6-4 Alloy Titanium markers or unalloyed Tantalum markers. PEEK-OPTIMA is a biocompatible radiolucent material, allowing visualization of osteogenesis.

### Characteristic Comparison:

The purpose of this submission is to add additional sizes to the Small PLATEAU Spacer system. The additional sizes fall within the range of sizes offered in the predicate systems. Additionally, they have the same intended use, material, and basic design as the predicate systems.

### Test Data:

Data was presented show that a new worst case is not being presented and to demonstrate the substantial equivalence of the Small PLATEAU Spacer System.

#### Substantial Equivalence:

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

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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 three stripes forming its body and wing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Life Spine, Inc. % Mr. Randy Lewis 2401 W. Hassell Road, Suite 1535 Hoffman Estates, Illinois 60169

JUL 1 9 2011

Re: K111835

Trade/Device Name: Small PLATEAU® Spacer System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: ODP Dated: June 27, 2011 Received: June 29, 2011

Dear Mr. Lewis:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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

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Page 2 - Mr. Randy Lewis

comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Mark N. Melkerson

Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

K川11435 510(k) number (if known):

## Device Name: Small PLATEAU® Spacer System

The Small PLATEAU Spacer System is intended for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one disc level (C2-TI). DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. This device is intended to be used with autogenous bone graft and a supplemental internal spinal fixation system.

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)

(Diysion Sign-Off) (Division of Surgical, Orthopedic, and Restorative Devices

KIJ1835 510(k) Number_