ELLIPSE OCCIPITO-CERICO-THORACIC SPINAL SYSTEM

K090565 · Globus Medical, Inc. · KWP · Jun 30, 2009 · Orthopedic

Device Facts

• Record ID: K090565
• Device Name: ELLIPSE OCCIPITO-CERICO-THORACIC SPINAL SYSTEM
• Applicant: Globus Medical, Inc.
• Product Code: KWP · Orthopedic
• Decision Date: Jun 30, 2009
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3050
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The ELLIPSE™ 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 surgerv, 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: thev are not intended for fixation of the posterior cervical spine. The ELLIPSE™ Occipito-Cervico-Thoracic Spinal System 3.5mm rods can also be linked to rod systems ranging in diameter from 3.5mm to 6.5mm, including the PROTEX® REVERE® or BEACON™ Stabilization Systems, using corresponding parallel connectors.

Device Story

Spinal fixation system for stabilization of cervical spine and occipito-cervico-thoracic junction. Components include 3.5mm rods, polyaxial screws, hooks, locking caps, and various connectors. Used by surgeons in clinical settings to provide structural support as adjunct to fusion. Implants are rigid hardware; no electronic or software components. System allows linking to other rod systems (PROTEX, REVERE, BEACON) via parallel connectors. Provides mechanical stabilization to treat degenerative conditions, fractures, and tumors; helps facilitate bone fusion.

Clinical Evidence

Bench testing only. No clinical data presented.

Technological Characteristics

Materials: Titanium alloy (ASTM F136, F1472, or F1295) or stainless steel (ASTM F138). Components: 3.5mm rods, polyaxial screws, hooks, locking caps, t-connectors, lateral connectors, parallel connectors, occipital plates, tapered rods. Mechanical fixation system; no energy source or software.

Indications for Use

Indicated for skeletally mature patients requiring stabilization of cervical spine and occipito-cervico-thoracic junction (occiput-T3) as adjunct to fusion. Conditions: degenerative disc disease, spondylolisthesis, spinal stenosis, fracture, dislocation, atlanto/axial fracture with instability, occipitocervical dislocation, revision of previous cervical surgery, and tumors. Contraindications: Polyaxial screws not for cervical spine (T1-T3 thoracic only); occipital bone screws not for posterior cervical spine 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 PROTEX® CT (K050391, K081906)
• Stryker Oasys (K032394)

Reference Devices

• PROTEX® Stabilization System
• REVERE® Stabilization System
• BEACON™ Stabilization System

Submission Summary (Full Text)

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

K090565

# 510(k) Summary: ELLIPSE™ 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 |

JUN 3 0 2009

- Device Name: ELLIPSE™ Occipito-Cervico-Thoracic Spinal System
Classification: Per 21 CFR as follows: \$888.3050 Spinal Interlaminal Fixation Orthosis Product Code KWP. Regulatory Class II, Panel Code 87.

- Globus PROTEX® CT K050391, K081906 Predicate(s): Stryker Oasys K032394
#### DEVICE DESCRIPTION:

The ELLIPSE™ Occipito-Cervico-Thoracic Spinal System consists of 3.5mm rods, polyaxial screws, hooks, locking caps, t-connectors, lateral connectors, parallel connectors, occipital plates, and tapered rods. 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 ELLIPSE™ 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 surgerv, 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: thev are not intended for fixation of the posterior cervical spine.

The ELLIPSE™ Occipito-Cervico-Thoracic Spinal System 3.5mm rods can also be linked to rod systems ranging in diameter from 3.5mm to 6.5mm, including the PROTEX® REVERE® or BEACON™ Stabilization Systems, using corresponding parallel connectors.

pg 1 of 2

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

K0905565

# Basis of Substantial Equivalence:

The ELLIPSE™ Occipito-Cervico-Thoracic Spinal System implants are similar to the predicate devices 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.

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

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three legs and a circular border. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the border of the circle.

Public Health Service

JUN 3 0 2009

ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Globus Medical Inc. % Kelly J. Baker, Ph.D 2560 General Armistead Avenue Audubon, Pennsylvania 19403

Re: K090565

Trade/Device Name: ELLIPSE™ Occipito-Cervico-Thoracic Spinal System Regulation Number: 21 CFR 888.3050 Regulation Name: Spinal interlaminal fixation orthosis Regulatory Class: II Product Code: KWP Dated: June 2, 2009 Received: June 3, 2009

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 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

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

### Page 2 - Dr. Kelly J. Baker

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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.

Sincerely yours,

Qbalora Buchus

Mark N. Melkerson Director Division of Surgical, Orthopedic, -and-Restorative-Devices-Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

# Indications for Use Statement

510(k) Number:

K090565

Device Name:

ELLIPSE™ Occipito-Cervico-Thoracic Spinal System

#### Indications:

The ELLIPSE™ 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 ELLIPSE™ Occipito-Cervico-Thoracic Spinal System 3.5mm rods can also be linked to rod systems ranging in diameter from 3.5mm to 6.5mm, including the PROTEX® or REVERE® or BEACON™ System, using corresponding parallel connectors.

Prescription Use × (Per 21 CFR §801.109)

Over

Over-The-Counter Use

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

ાર

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K090565