CORRIDOR FIXATION SYSTEM

K083442 · Globus Medical, Inc. · MRW · Feb 6, 2009 · OR

Device Facts

• Record ID: K083442
• Device Name: CORRIDOR FIXATION SYSTEM
• Applicant: Globus Medical, Inc.
• Product Code: MRW · OR
• Decision Date: Feb 6, 2009
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

The CORRIDOR™ Fixation System is intended to stabilize the spine as an aid to fusion through bilateral immobilization of the facet joints, with or without bone graft, at single or multiple levels, from C2 to S1 for 3.5mm and 4.0mm screws and from L1 to S1 for 4.5mm screws. For transfacet fixation, the screws are inserted posteriorly through the superior side of the facet, across the facet joint, into the pedicle. For translaminar facet fixation, the screws are inserted posteriorly through the lateral aspect of the spinous process, through the lamina, through the superior side of the facet, across the facet joint, and into the pedicle. The CORRIDOR™ Fixation System is indicated for treatment of any or all of the following: pseudoarthrosis and failed previous fusions which are symptomatic or which may cause secondary instability or deformity; spondylolisthesis; spondylolysis; degenerative disc disease (DDD) as defined by neck and/or back pain of discogenic origin as confirmed by radiographic studies; degeneration of facet joints; spinal instability and trauma including spinal fractures and/or dislocations.

Device Story

CORRIDOR™ Fixation System consists of titanium alloy screws designed for spinal stabilization; facilitates bilateral facet joint immobilization to aid fusion. Screws available in partially/fully threaded, cannulated/non-cannulated configurations; various diameters/lengths accommodate patient anatomy. Used by surgeons in clinical settings; inserted posteriorly via transfacet or translaminar approaches into pedicles. Provides mechanical stabilization of spinal segments; intended to address instability, deformity, or pain associated with degenerative conditions or trauma. Benefits patient by promoting fusion and restoring spinal stability.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Medical grade titanium alloy (ASTM F136 and F1295). Screws are partially or fully threaded, cannulated or non-cannulated. Dimensions vary by diameter and length. Mechanical fixation device; no energy source or software.

Indications for Use

Indicated for patients requiring spinal stabilization as an aid to fusion via bilateral facet joint immobilization. Applicable for single or multiple levels (C2-S1 for 3.5/4.0mm screws; L1-S1 for 4.5mm screws). Conditions include pseudoarthrosis, failed previous fusions, spondylolisthesis, spondylolysis, degenerative disc disease (DDD), facet joint degeneration, spinal instability, and trauma (fractures/dislocations).

Submission Summary (Full Text)

{0}------------------------------------------------

Kogzy42

# 510(k) SUMMARY: CORRIDOR™ Fixation System

FEB = 6 2009

Globus Medical Inc. Company: 2560 General Armistead Ave. Audubon, PA 19403 [phone]

Kelly J. Baker, Ph.D Contact: Director, Clinical Affairs & Regulatory

CORRIDOR™ Fixation System Device Name:

Classification: Product Code MRW. Class II.

Legally marketed predicated devices Predicate(s):

#### Device Description:

The CORRIDOR™ Fixation System consists of screws designed to compact juxtaposed facet articular processes to enhance spinal fusion. The screws are javailable partially threaded or fully threaded, cannulated or non-cannulated, and in various diameters and lengths to accommodate patient anatomy. The CORRIDOR™ Fixation System screws are fabricated from medical grade titanium alloy as specified in ASTM F136 and F1295. Due to the risk of galvanic thanian alloy as open antation, titanium alloy implants should not be used in the same construct as stainless steel implants.

#### Intended Use:

The CORRIDOR™ Fixation System is intended to stabilize the spine as an aid to fusion through bilateral immobilization of the facet joints, with or without bone graft, at single or multiple levels, from C2 to S1 for 3.5mm and 4.0mm screws i and from L1 to S1 for 4.5mm screws. For transfacet fixation, the screws are inserted posteriorly through the superior side of the facet, across the facet joint, into the pedicle. For translaminar facet fixation, the screws are inserted posteriorly through the lateral aspect of the spinous process, through the lamina, through the superior side of the facet, across the facet joint, and into the pedicle.

The CORRIDOR™ Fixation System is indicated for treatment of any or all of the following: pseudoarthrosis and failed previous fusions which are symptomatic or which may cause secondary instability or deformity; spondylolisthesis; spondylolysis; degenerative disc disease (DDD) as defined by neck and/or back pain of discogenic origin as confirmed by radiographic studies; degeneration of pan or alooogine ontability and trauma including spinal fractures and/or dislocations.

#### Basis for Substantial Equivalence:

CORRIDOR™ Fixation System is similar in terms of indications, design, materials, and performance, to currently marketed devices.

Page 1 of 1

{1}------------------------------------------------

### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its wing and body. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

FEB - 6 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Globus Medical, Inc. % Dr. Kelly J. Baker 2560 General Armistead Ave., Valley Forge Audubon, PA 19403

Re: K083442

Trade/Device Name: Corridor Fixation System Regulation Number: Unclassified Regulation Name: N/A Regulatory Class: Unclassified Product Code: MRW Dated: November 19, 2008 Received: November 20, 2008

Dear Dr. 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 forth in the quality systems (OS) 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

{2}------------------------------------------------

Page 2 – Dr. Kelly J. Baker

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 at If you desire specific at not to res your adological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to [phone]. Albo, productions also 2.97). For questions regarding postmarket surveillance, premarket nothleanon (21CFR Pac 307.97). Fer questions prease contact CDRT 3 Office of Surventions regarding the reporting of device alverse events Surveillance at (240) 270g (MDR)), please contact the Division of Surveillance Systems (Medical Device Reporting (MDIC)), proase venal information on your responsibilities under the at [phone]. Tournal Manufacturers, International and Consumer Assistance Act from the Drivision of E38-2041 or [phone] or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark N. Millican

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{3}------------------------------------------------

## Indications for Use Statement

K083442 510(k) Number:

Device Name:

CORRIDOR™ Fixation System

#### Indications:

The CORRIDOR™ Fixation System is intended to stabilize the spine as an aid to fusion through bilateral immobilization of the facet joints, with or without bone graft, at single or multiple levels, from C2 to S1 for 3.5mm and 4.0mm screws grant, at single of maniple foreis, For transfacet fixation, the screws are inserted posteriorly through the superior side of the facet, across the facet joint, inserted postenony through the capital in facet fixation, the screws are inserted and into the podicio. The lateral aspect of the spinous process, through the lamina, postenony through the facet, across the facet, across the facet joint, and into the pedicle.

The CORRIDOR™ Fixation System is indicated for treatment of any or all of the following: pseudoarthrosis and failed previous fusions which are symptomatic or which may cause secondary instability or deformity; spondylolisthesis; which "may" oadso - occomation disease (DDD) as defined by neck and/or back spondylorying as confirmed by radiographic studies; degeneration of pain of disoogenio ontability and trauma including spinal fractures and/or dislocations.

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)

(Division Sign-Off) Division of General, Restorative. and Neurological Devices

**510(k) Number** 2/6/05