(78 days)
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, and 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 the spine; instability and trauma including spinal fractures and/or dislocations.
The CORRIDOR™ Fixation System consists of screws designed to compact juxtaposed facet articular processes to enhance spinal fusion. The screws are available 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 corrosion, titanium alloy implants should not be used in the same construct as stainless steel implants.
This document is a 510(k) summary for the Globus Medical Inc. CORRIDOR™ Fixation System, a spinal implant. It describes the device, its intended use, and states that it is substantially equivalent to legally marketed predicate devices based on similarities in indications, design, materials, and performance.
The provided text does not contain any information regarding the acceptance criteria for a device, a study proving the device meets those criteria, or any details about a study's methodology, sample sizes, expert involvement, ground truth, or statistical analysis.
Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria from the given input. The document is solely a regulatory submission summary for substantial equivalence, not a scientific study report.
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Kogzy42
510(k) SUMMARY: CORRIDOR™ Fixation System
FEB = 6 2009
Globus Medical Inc. Company: 2560 General Armistead Ave. Audubon, PA 19403 (610) 415-9000
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
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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
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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 (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to (240) 270-0120. 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 (240) 270-5401. Tournal Manufacturers, International and Consumer Assistance Act from the Drivision of E38-2041 or (240) 276-3150 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
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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
N/A