LIFE SPINE STAND-ALONE SPACER SYSTEM

K091301 · Life Spine · OVD · Dec 15, 2009 · Orthopedic

Device Facts

• Record ID: K091301
• Device Name: LIFE SPINE STAND-ALONE SPACER SYSTEM
• Applicant: Life Spine
• Product Code: OVD · Orthopedic
• Decision Date: Dec 15, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The Life Spine Stand-Alone 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. The Life Spine Stand-Alone Spacer System is intended for use with four titanium alloy screws which are provided with the system. If the physician chooses to use fewer than four of the provided screws, then a supplemental internal spinal fixation system that is cleared for use in the lumbosacral spine must be used.

Device Story

Intervertebral body fusion device; used in spinal fusion procedures. Implants consist of PEEK-OPTIMA LT1 spacer with tantalum markers; hollow center for autogenous bone graft packing. Superior/inferior surfaces feature teeth for vertebral endplate interface to prevent rotation/migration. Includes titanium alloy (6AL-4V-ELI) anterior fixation plate with four integrated screw holes for titanium alloy screws to anchor to adjacent vertebrae. Used by surgeons in clinical settings. If fewer than four screws are used, supplemental internal spinal fixation is required. Benefits include stabilization of the intervertebral space to promote fusion in patients with DDD.

Clinical Evidence

No clinical data provided; substantial equivalence is based on design, material, and functional comparisons to predicate devices.

Technological Characteristics

Materials: PEEK-OPTIMA LT1, tantalum markers, titanium alloy (6AL-4V-ELI per ASTM F-136). Design: Hollow spacer with teeth for endplate interface; anterior fixation plate with four screw holes. 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

• Life Spine Plateau® Spacer System (K080411)
• Blackstone PILLAR™ SA PEEK Spacer System (K081849)
• Synthes SynFix "-LR (K072253)
• Biomet Solitaire™ PEEK-Optima® (K081395)
• Surgicraft STALIF™ TT (K073109)

Submission Summary (Full Text)

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lifespine.com

# 510(k) Summary * LIFE SPINE® Stand-Alone Spacer System

Submitted By:

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

510(k) Contact:

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

LIFE SPINE® Stand-Alone Spacer System

Intervertebral Body Fusion Device

DEC 1 5 2009

Date Prepared:

May 1, 2009

Trade Name:

Common Name:

Class II

Product Code:

Classification:

MAX - Intervertebral Fusion Device with Bone Graft, Lumbar 21 CFR 888.3080 - Intervertebral Body Fusion Device

Predicate Devices:

Life Spine Plateau® Spacer System (K080411) Blackstone PILLAR™ SA PEEK Spacer System (K081849) Synthes SynFix "-LR (K072253) Biomet Solitaire™ PEEK-Optima® (K081395) Surgicraft STALIF™ TT (K073109)

#### Device Description:

The Life Spine Stand-Alone Spacer System implants are intervertebral body fusion devices comprised of a variety of spacer implants manufactured from Polyetheretherketone (PEEK-OPTIMA LT1) with tantalum markers. The spacers are hollow to permit packing with 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 help prevent rotation and/or migration. Additionally, the implants incorporate a titanium alloy (6AL-4V-ELI per ASTM F-136) anterior fixation plate which has integrated screw holes to allow for placement of four titanium alloy screws that anchor the implant to the adjacent vertebrae. The implants are available in a range of sizes and footprints to suit the individual pathology and anatomicial conditions of the patient.

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Image /page/1/Picture/0 description: The image shows the logo for Life Spine. The words "Life Spine" are written in a bold, sans-serif font. There is a curved line underneath the words, which may represent a spine. The logo is simple and modern.

Page 2 KO91301 401 W. Hassell Boad fran Estates, IL 60169 0847.884.6117 847.884.6118 ww.lifespine.com

### Intended Use of the Device:

The Life Spine Stand-Alone 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.

The Life Spine Stand-Alone Spacer System is intended for use with four titanium alloy screws which are provided with the system. If the physician chooses to use fewer than four of the provided screws, then a supplemental internal spinal fixation system that is cleared for use in the lumbosacral spine must be used.

## Substantial Equivalence:

The Life Spine Stand-Alone 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 its wings spread, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.

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

SEP 1 2 2011

Life Spine, Inc. % Mr. Michael S. Butler President & CEO 2401 West Hassell Road, Suite 1535 Hoffman Estates, Illinois 60169

- Re: K091301
Trade/Device Name: Life Spine Stand-Alone Spacer System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: OVD Dated: November 24, 2009 Received: November 25, 2009

Dear Mr. Butler:

This letter corrects our substantially equivalent letter of December 15, 2009.

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 (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 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

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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); 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/CDRHQffices/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,
Mule A. Mulkerson

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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2401 W. Hassell Road Suite 1535 Hoffman Estates, IL 60169 p 847.884.6117 f 847.884.6118 www.lifespine.com

# Indications for Use

510(k) number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: LIFE SPINE® Stand-Alone Spacer System

The Life Spine Stand-Alone Spacer System 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.

The Life Spine Stand-Alone Spacer System is intended for use with four titanium alloy screws which are provided with the system. If the physician chooses to use fewer than four of the provided screws, then a supplemental internal spinal fixation system that is cleared for use in the lumbosacral spine must be used.

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

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

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

KO91301 510(k) Number_