NIKO CORPECTOMY SPACER

K072465 · Globus Medical, Inc. · MQP · Oct 4, 2007 · Orthopedic

Device Facts

• Record ID: K072465
• Device Name: NIKO CORPECTOMY SPACER
• Applicant: Globus Medical, Inc.
• Product Code: MQP · Orthopedic
• Decision Date: Oct 4, 2007
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The NIKO™ Corpectomy Spacer is a vertebral body replacement device intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e., fracture). The NIKO™ Corpectomy Spacer is intended to be used with supplemental spinal fixation systems that have been labeled for use in the thoracic and/or lumbar spine (i.e., posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems). The interior of the spacer can be packed with bone grafting material. The NIKO™ Corpectomy Spacer is designed to provide anterior spinal column support even in the absence of fusion for a prolonged period.

Device Story

NIKO™ Corpectomy Spacer is a vertebral body replacement implant for thoracolumbar spine (T1-L5). Device provides anterior spinal column support following corpectomy or vertebrectomy for tumor or trauma. System consists of spacers with varying heights/footprints; axial hole allows packing with bone graft material; superior/inferior surface protrusions grip vertebral endplates to resist expulsion. Used in clinical/surgical settings by surgeons; requires supplemental spinal fixation (e.g., pedicle screw/rod systems, anterior plates). Provides structural stability; supports spinal column even without fusion.

Clinical Evidence

Bench testing only; performed in accordance with the "Guidance for Industry and FDA Staff, Guidance for Spinal System 510(k)s".

Technological Characteristics

Materials: radiolucent polymer, titanium alloy, tantalum. Standards: ASTM F2026, F136, F1295, F560. Form factor: spacer with axial hole and surface protrusions for endplate fixation. Mechanical principle: structural support via vertebral body replacement.

Indications for Use

Indicated for skeletally mature patients requiring vertebral body replacement in the thoracolumbar spine (T1-L5) due to tumor or trauma (fracture). Must be used with supplemental spinal fixation systems.

Regulatory Classification

Identification

A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.

Predicate Devices

• Sustain Radiolucent Spacer (K040284)

Submission Summary (Full Text)

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#### 111. 510(k) Summary

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# SUBMITTED BY:

Globus Medical Inc. 2560 General Armistead Ave Audubon, PA 19403 [phone] Contact: Kelly J. Baker

2007 OCT 4

# DEVICE NAME:

NIKO™ Corpectomy Spacer

## CLASSIFICATION:

Per CFR 21 §888.3060: Implant, fixation, spinal intervertebral body fixation orthosis devices. Class II. The Product Code is MQP. The Panel Code is 87.

# PREDICATE DEVICES:

Sustain Radiolucent Spacer K040284; SE date March 23, 2004

# DEVICE DESCRIPTION:

The NIKO™ Corpectomy Spacer device is a vertebral body replacement device used to provide structural stability in skeletally mature individuals following corpectomy or vertebrectomy. The system is comprised of spacers of various heights and footprints to fit the anatomical needs of a wide variety of patients. Each spacer has an axial hole to allow grafting material to be packed inside of the spacer. Protrusions on the superior and inferior surfaces of the device will grip the endplates of the adjacent vertebrae to resist expulsion.

NIKO devices are made from radiolucent polymer, and titanium alloy or tantalum as specified in F2026, F136, F1295, and F560.

## INTENDED USE:

The NIKO™ Corpectomy Spacer is a vertebral body replacement device intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e., fracture).

# PERFORMANCE DATA:

Mechanical testing in accordance with the "Guidance for Industry and FDA Staff, Guidance for Spinal System 510(k)s", May 3, 2004 is presented.

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# BASIS OF SUBSTANTIAL EQUIVALENCE:

The NIKO™ Corpectomy Spacer implants are similar to the predicate vertebral body replacement device, Sustain Radiolucent Spacer (K040284), with respect to indications for use, material, principles of operation, and performance.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Globus Medical Inc. % Ms. Kelly Baker Valley Forge Business Center 2560 General Armistead Avenue Audubon, PA 19403

2007

Re: K072465

Trade/Device Name: NIKOTM Corpectomy Spacer Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: MQP Dated: August 30, 2007 Received: September 4, 2007

Dear Ms. Baker:

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

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Page 2 – Ms. Kelly Baker

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.

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 Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 vours.

Barbara Pvet

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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#### ll. Indications for Use Statement

510(k) Number:

NIKO™ Corpectomy Spacer Device Name:

### Indications:

The NIKO™ Corpectomy Spacer is a vertebral body replacement device intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e., fracture). The NIKO™ Corpectomy Spacer is intended to be used with supplemental spinal fixation systems that have been labeled for use in the thoracic and/or lumbar spine (i.e., posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems). The interior of the spacer can be packed with bone grafting material.

The NIKO™ Corpectomy Spacer is designed to provide anterior spinal column support even in the absence of fusion for a prolonged period.

Prescription Use × (Per 21 CFR §801.109)

OR

Over-The-Counter Use

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

2

Clarbare RniemD

. Restorative, and Neurological Devices

510(k) Number K072463