PROTEX CT CERVICOTHORACIC SPINAL SYSTEM

K081906 · Globus Medical, Inc. · KWP · Nov 14, 2008 · Orthopedic

Device Facts

• Record ID: K081906
• Device Name: PROTEX CT CERVICOTHORACIC SPINAL SYSTEM
• Applicant: Globus Medical, Inc.
• Product Code: KWP · Orthopedic
• Decision Date: Nov 14, 2008
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3050
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The PROTEX® CT Occipito-Cervico-Thoracic Spinal System is intended to be used in skeletally mature patients as an adjunct to fusion using autograft or allograft, for stabilization of the cervical spine and occipito-cervico-thoracic iunction (occiput-T3) for the following conditions: degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), spondylolisthesis, spinal stenosis, fracture, dislocation, atlanto/axial fracture with instability, occipitocervical dislocation, revision of previous cervical spine surgery, and tumors. The use of polyaxial screws is limited to placement in the upper thoracic spine (T1-T3) in treating thoracic conditions only. They are not intended to be placed in the cervical spine. Occipital bone screws are limited to occipital fixation; they are not intended for fixation of the posterior cervical spine. The 3.2mm rod implants are for use in the cervical and upper thoracic spine and are not intended for occipital fixation. The PROTEX® CT Occipito-Cervico-Thoracic Spinal System 3.7mm rods can also be linked to rod systems ranging in diameter from 3.7mm to 6.5mm, including the PROTEX® or REVERE® System, using corresponding parallel connectors.

Device Story

Spinal fixation system consisting of rods (3.2mm, 3.7mm), polyaxial screws, hooks, locking caps, and various connectors (t-connectors, lateral, parallel) and occipital clamps. Used by surgeons in clinical settings to provide stabilization of the cervical spine and occipito-cervico-thoracic junction (occiput-T3) as an adjunct to fusion. Implants are secured to the spine to address conditions like degenerative disc disease, fractures, and tumors. System allows for linking to other rod systems (3.7mm-6.5mm) via parallel connectors. Benefits include spinal stabilization and support for fusion in skeletally mature patients.

Clinical Evidence

Bench testing only. No clinical data presented.

Technological Characteristics

Implants composed of titanium alloy (ASTM F136, F1472, or F1295) or stainless steel (ASTM F138). System includes rods, polyaxial screws, hooks, locking caps, and connectors. Galvanic corrosion warning prohibits mixing titanium and stainless steel. Mechanical performance validated per FDA spinal system guidance.

Indications for Use

Indicated for skeletally mature patients requiring stabilization of the cervical spine and occipito-cervico-thoracic junction (occiput-T3) as an adjunct to fusion for degenerative disc disease, spondylolisthesis, spinal stenosis, fracture, dislocation, atlanto/axial fracture with instability, occipitocervical dislocation, revision surgery, and tumors. Contraindications: Polyaxial screws not for cervical spine; occipital screws not for posterior cervical spine; 3.2mm rods not for occipital fixation.

Regulatory Classification

Identification

A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.

Predicate Devices

• Globus Medical PROTEX® CT Cervicothoracic Spinal System (K050391)

Reference Devices

• PROTEX® System
• REVERE® System

Submission Summary (Full Text)

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# NOV 1 4 2008

## 510(K) Summary: PROTEX® CT Occipito-Cervico-Thoracic Spinal System

| Company: | Globus Medical Inc.<br>2560 General Armistead Ave.<br>Audubon, PA 19403<br>[phone] |
|-----------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Kelly J. Baker, Ph.D<br>Director, Clinical Affairs & Regulatory |
| Device Name: | PROTEX® CT Occipito-Cervico-Thoracic Spinal System |
| Classification: | Per 21 CFR as follows:<br>§888.3050 Spinal Interlaminal Fixation Orthosis<br>Product Code KWP.<br>Regulatory Class II, Panel Code 87. |
| Predicate(s): | Globus Medical PROTEX® CT Cervicothoracic Spinal System<br>K050391, SE date February 15, 2005<br>Product Code KWP and MNI<br>Regulatory Class II, Panel Code 87. |

#### Device Description:

The PROTEX™ CT Occipito-Cervico-Thoracic Spinal System consists of 3.2mm and 3.7mm rods, polyaxial screws, hooks, locking caps, t-connectors, lateral connectors, parallel connectors, and occipital clamps. The implants are composed of titanium alloy (per ASTM F136, F1472, or F1295), or stainless steel (per ASTM F138).

Due to the risk of galvanic corrosion following implantation, titanium alloy implants should not be connected to stainless steel implants.

#### Intended Use:

The PROTEX® CT Occipito-Cervico-Thoracic Spinal System is intended to be used in skeletally mature patients as an adjunct to fusion using autograft or allograft, for stabilization of the cervical spine and occipito-cervico-thoracic iunction (occiput-T3) for the following conditions: degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), spondylolisthesis, spinal stenosis, fracture, dislocation, atlanto/axial fracture with instability, occipitocervical dislocation, revision of previous cervical spine surgery, and tumors.

The use of polyaxial screws is limited to placement in the upper thoracic spine (T1-T3) in treating thoracic conditions only. They are not intended to be placed in the cervical spine. Occipital bone screws are limited to occipital fixation; they are not intended for fixation of the posterior cervical spine. The 3.2mm rod

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K081906

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implants are for use in the cervical and upper thoracic spine and are not intended for occipital fixation.

The PROTEX® CT Occipito-Cervico-Thoracic Spinal System 3.7mm rods can also be linked to rod systems ranging in diameter from 3.7mm to 6.5mm, including the PROTEX® or REVERE® System, using corresponding parallel connectors.

#### Basis of Substantial Equivalence:

The PROTEX® CT additional implants are similar to the predicate PROTEX® CT implants with respect to technical characteristics, performance, and intended use. 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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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/2/Picture/2 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with its wings spread, symbolizing protection and care. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", indicating the department's name and national affiliation. The overall design is simple yet recognizable, representing the department's role in public health and human services.

NOV 1 4 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Globus Medical Inc. % Kelly J. Baker, Ph.D. Director, Clinical Affairs & Regulatory 2560 General Armistead Avenue Audubon, Pennsylvania 19403

Re: K081906

Trade/Device Name: PROTEX® CT Occipito-Cervico-Thoracic Spinal System Regulation Number: 21 CFR 888.3050 Regulation Name: Spinal interlaminal fixation orthosis. Regulatory Class: II Product Code: KWP Dated: October 14, 2008 Received: October 15, 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 (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 - Kelly J. Baker, Ph.D.

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance. please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. 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/industry/support/index.html.

Sincercly yours,

Mark of Milker

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

510(k) Number:

K081906

Device Name:

PROTEX® CT Occipito-Cervico-Thoracic Spinal System

#### INDICATIONS:

The PROTEX® CT Occipito-Cervico-Thoracic Spinal System is intended to be used in skeletally mature patients as an adjunct to fusion using autograft or allograft, for stabilization of the cervical spine and occipito-cervico-thoracic junction (occiput-T3) for the following conditions: degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), spondylolisthesis, spinal stenosis, fracture, dislocation, atlanto/axial fracture with instability, occipitocervical dislocation, revision of previous cervical spine surgery, and tumors.

The use of polyaxial screws is limited to placement in the upper thoracic spine (T1-T3) in treating thoracic conditions only. They are not intended to be placed in the cervical spine. Occipital bone screws are limited to occipital fixation; they are not intended for fixation of the posterior cervical spine. The 3.2mm rod implants are for use in the cervical and upper thoracic spine and are not intended for occipital fixation.

The PROTEX® CT Occipito-Cervico-Thoracic Spinal System 3.7mm rods can also be linked to rod systems ranging in diameter from 3.7mm to 6.5mm,
including the PROTEX® or REVERE® System, using corresponding parallel connectors.

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)

DL

Division of General. Restorative. and Neurological Devices

**510(k) Number** k081506