SUSTAIN SPACER

K031302 · Globus Medical, Inc. · MQP · Jun 27, 2003 · Orthopedic

Device Facts

• Record ID: K031302
• Device Name: SUSTAIN SPACER
• Applicant: Globus Medical, Inc.
• Product Code: MQP · Orthopedic
• Decision Date: Jun 27, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

Sustain Spacer is a vertebral body replacement implant for thoracolumbar spine (T1-L5). Device provides anterior spinal column support following corpectomy or vertebrectomy; used in cases of tumor or trauma-induced vertebral collapse. System consists of titanium spacers with fixed heights and footprints; axial hole allows packing with bone grafting material. Superior and inferior surface protrusions grip vertebral endplates to resist expulsion. Device requires use with supplemental spinal fixation systems (e.g., pedicle screws, rods, anterior plates). Intended for use by surgeons in clinical settings.

Clinical Evidence

Bench testing only. Mechanical testing was conducted in accordance with the FDA guidance document 'Guidance for Industry and FDA Staff, Guidance for Spinal System 510(k)s' (September 27, 2000) to demonstrate substantial equivalence.

Technological Characteristics

Materials: Commercially pure titanium or titanium alloy per ASTM F67, F136, and F1295. Design: Fixed height/footprint spacers with axial graft-packing hole and endplate-gripping protrusions. Energy source: None (passive implant). Connectivity: None.

Indications for Use

Indicated for skeletally mature patients requiring vertebral body replacement in the thoracolumbar spine (T1-L5) due to tumor or trauma-induced collapse, damage, or instability. 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

• Synthes SynMesh System (K003275)
• Synthes Vertebral Spacer Ti (K020152)
• Synthes Vertebral Spacer Ti (Narrow and Curved) (K024364)

Submission Summary (Full Text)

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#### III. 510(K) SUMMARY

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# SUBMITTED BY:

JUN 2 7 2003

Globus Medical Inc. 303 Schell Lane Phoenixville, PA 19460 [phone] Contact: Daniel S. Paul

## DEVICE NAME:

Sustain Spacer

## CLASSIFICATION:

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

## PREDICATE DEVICES:

Synthes SynMesh System: K003275 SE date: April 23, 2001 And Synthes Vertebral Spacer Ti: K020152 SE date: April 16, 2002 And Synthes Vertebral Spacer Ti (Narrow and Curved): K024364 SE Date: March 17, 2003

## DEVICE DESCRIPTION:

The Sustain Spacer is a vertebral body replacement device used to provide structural stability in skeletally mature individuals following corpectorny or vertebrectomy. The system is comprised of spacers of various fixed 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 each device will grip the endplates of the adjacent vertebrae to resist expulsion.

The Sustain Spacer devices are made from commercially pure titanium or titanium alloy as specified in ASTM F67, F136 and F1295.

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## INTENDED USE:

**K031302**
Page 2 of 2

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

## PERFORMANCE DATA:

Mechanical testing in accordance with the "Guidance for Industry and FDA Staff, Guidance for Spinal System 510(k)s", September 27, 2000 was presented.

## BASIS OF SUBSTANTIAL EQUIVALENCE:

The Sustain Spacer implants are similar to the predicate Synthes SvnMesh vertebral body replacement device(s). (K003275) and Synthes Vertebral Spacer Ti vertebral body replacement device(s) (K020125 and K024364) with respect to technical characteristics and performance.

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Public Health Service

JUN 2 7 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Daniel S. Paul Direactor, Quality Assurance and Regulatory Affairs Globus Medical Inc. 303 Schell Lane Phoenixville, PA 19460

K031302 Trade Name: Sustain Spacer Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: MQP Dated: April 23 and May 13, 2003 Received: April 24 and May 15, 2003

Dear Mr. Paul:

Re:

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 - Mr. Daniel S. Paul

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 its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

b. Mark A. Millessen

Celia M. Witten, Ph.D., M.D. 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 Statement

K031302 510(k) Number:

Device Name: Sustain Spacer

#### Indications:

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter Use

03/302

Mark N. Milliken

Division Sign-Off Division of General, Restorative and Neurological Devices

510(k) Number_