PLATEAU SPACER SYSTEM

K121116 · Life Spine · MAX · May 8, 2012 · Orthopedic

Device Facts

• Record ID: K121116
• Device Name: PLATEAU SPACER SYSTEM
• Applicant: Life Spine
• Product Code: MAX · Orthopedic
• Decision Date: May 8, 2012
• Decision: SESE
• Submission Type: Special
• 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 disc 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 (e.g., pedicle screw or anterolateral plating system) that is cleared for use in the lumbosacral spine.

Device Story

Intervertebral body fusion device; hollow PEEK-OPTIMA LT1 implant with tantalum or titanium markers; designed for insertion into disc space to promote fusion; requires autogenous bone graft packing; features teeth on superior/inferior surfaces to prevent migration/rotation; used in spinal fusion procedures by surgeons; requires supplemental internal fixation (e.g., pedicle screws); provides structural support to disc space; benefits patients by facilitating fusion in degenerative disc disease.

Clinical Evidence

No clinical data; substantial equivalence supported by engineering analysis.

Technological Characteristics

Material: PEEK-OPTIMA LT (ASTM F2026) with tantalum or 6-4 alloy titanium markers. Design: Hollow intervertebral spacer with surface teeth. Energy source: None (mechanical). Connectivity: None. Sterilization: Not specified.

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.

Predicate Devices

• Plateau Spacer System (K080411)
• Nuvasive CoRoent (K071795)
• Pioneer CrossFuse (K112496)

Submission Summary (Full Text)

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K121116 page 1 of 2

MAY - 8 2012

## 510(k) Summary PLATEAU®-X Spacer System

Submitted By:

Life Spine. Inc. 2401 W. Hassell Road, Suite 1535 Hoffman Estates, IL 60169 Telephone: [phone] Fax: [phone]

510(k) Contact:

Randy Lewis Life Spine 2401 W. Hassell Road, Suite 1535 Hoffman Estates, IL 60169 Telephone: [phone] Fax: [phone]

Date Prepared:

Trade Name:

April 11th, 2012

Life Spine Plateau Spacer System

Intervertebral Body Fusion Device

Common Name:

Classification: MAX, 21 CFR 888.3080, Class II

Predicate Device:

Plateau Spacer System (K080411), Nuvasive CoRoent (K071795), Pioneer CrossFuse (K112496)

#### 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 Polyetheretherketone (PEEK-OPTIMA LT1) with tantalum 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 Plateau Spacer System components from any other system or manufacturer. The Plateau Spacer System components should never be reused under any circumstances.

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### Intended Use of the Device:

The Plateau Spacer System is intended for spinal fusion procedures in skeletally mature patients with degenerative disc 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 (e.g., pedicle screw or anterolateral plating system) that is cleared for use in the lumbosacral spine.

### Material:

The PLATEAU Spacer System implants are manufactured according to ASTM F2026 from Polyetheretherketone (PEEK-OPTIMA LT), 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 a Lateral implant offering of the PLATEAU Spacer System. The line extension has the same intended use, material, and basic design as the predicate systems.

#### Performance Data:

Engineering analysis has been presented to show that the line extension does not impose a new worst case scenario and is therefore substantially equivalent to the predicate devices.

#### Conclusion:

The 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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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three intertwined snakes around a staff. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the caduceus. The seal is black and white.

#### Public Health Service

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

Life Spine, Inc. % Mr. Randy Lewis RA/QA Manager 2401 West Hassell Road, Suite 1535 Hoffman Estates, Illinois 60169

Re: K121116

Trade/Device Name: Plateau Spacer System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: April 11, 2012 Received: April 12, 2012

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 I va mayy merely missions 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 adulteration. Trease nowever, 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 If your device 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 r that FDA has made a determination that your device complies with other requirements of the Act that 1 271 has Intact a and regulations administered by other Federal agencies. You must or any I oderal battle and registements, including, but not limited to: registration and listing (21 CHR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical CI IC rated adverse events) (21 CFR 803); good manufacturing practice requirements as set de vice-refated daverse ovents) (21 Coronation (21 CFR Part 820); and if applicable, the electronic forth in the quality byelting (Sections 531-542 of the Act); 21 CFR 1000-1050.

MAY -- 8 2012

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## Page 2 - Mr. Randy Lewis

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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Eun Keitt

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

510(k) number (if known): K/21116

# Device Name: PLATEAU®-X Spacer System

The Plateau Spacer System is intended for spinal fusion procedures in skeletally mature patients with degenerative disc 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 (e.g., pedicle screw or anterolateral plating 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)

(Div/sion Sign-Off)

Division of Surgical, Orthopedic, and Restorative Devices

K121116 510(k) Number_