SPECTRUM CERVICAL SPINAL SYSTEM

K022997 · Spinal Innovations, LLC · KWQ · Dec 6, 2002 · Orthopedic

Device Facts

• Record ID: K022997
• Device Name: SPECTRUM CERVICAL SPINAL SYSTEM
• Applicant: Spinal Innovations, LLC
• Product Code: KWQ · Orthopedic
• Decision Date: Dec 6, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Spinal Innovations SPECTRUM™ Cervical Spinal System is intended for anterior intervertebral body screw fixation of the cervical spine. The system implants are indicated for use in the temporary stabilization of the anterior spine during the development of cervical spine fusions in patients with degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures or dislocation), tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudoarthrosis, and/or failed previous fusions. Warning: This device is not approved for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.

Device Story

The SPECTRUM Cervical Spinal System is an anterior intervertebral body screw fixation system used for temporary stabilization during cervical spine fusion. The system consists of plates with varying lordotic geometries and widths, and cancellous bone screws available in fixed or variable angles. The device is implanted by a surgeon in a clinical setting. The screw locking mechanism is pre-assembled to the plate during manufacturing. By providing rigid fixation to the anterior cervical spine, the system supports the development of spinal fusion, potentially alleviating symptoms associated with degenerative disc disease, trauma, or deformity. The device is not intended for posterior fixation.

Clinical Evidence

Bench testing only. Biomechanical testing demonstrated equivalent mechanical performance compared to predicate devices.

Technological Characteristics

Anterior cervical plate and screw fixation system. Components include plates (two widths, two lordotic geometries) and cancellous bone screws (4.0mm and 4.5mm diameters). Features pre-assembled screw locking mechanism. Mechanical fixation principle.

Indications for Use

Indicated for patients requiring temporary anterior cervical spine stabilization during fusion. Conditions include degenerative disc disease, trauma (fractures/dislocations), tumors, deformity (kyphosis, lordosis, scoliosis), pseudoarthrosis, and failed previous fusions. Contraindicated for posterior element (pedicle) fixation.

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

• Sofamor Danek Orion™ Anterior Cervical Plate System
• Sofamor Danek Atlantis™ Anterior Cervical Plate System
• Medtronic Sofamor Danek Zephir™ Anterior Cervical Plate System
• Synthes Cervical Spine Locking Plate System

Submission Summary (Full Text)

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# DEC 0 6 2002

## 510 (K) Summary of Safety and Effectiveness

| Company Name: | Spinal Innovations, Inc.<br>7850 Stage Hills Blvd.<br>Suite 105<br>Bartlett, TN 38133<br>[phone]<br>[phone] fax |
|----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Contact: | Joseph S. Clift<br>Vice President of Regulatory<br>And Clinical Affairs<br>[phone] |
| Trade Name: | Spinal Innovations SPECTRUM™<br>Cervical Spinal System |
| Common Name: | Plate and Screw Cervical Spinal<br>Fixation System |
| Classification: | 888.3060 Spinal Intervertebral Body<br>Fixation Orthosis - classII |
| Device Product Code: | 87 KWQ |
| Predicate Devices: | Sofamor Danek Orion™ Anterior<br>Cervical Plate System,<br>Sofamor Danek Atlantis™ Anterior<br>Cervical Plate System,<br>Medtronic Sofamor Danek Zephir™<br>Anterior Cervical Plate System,<br>Synthes Cervical Spine Locking<br>Plate System, and |

#### Device Description

The Spinal Innovations SPECTRUM™ Cervical Spinal System is intended for anterior intervertebral body screw fixation of the cervical spine. This system includes plates in varying designs and both fixed angle and variable angle screws. The screws are available in diameters of 4.0 mm and 4.5 mm and varying lengths. The plates have two widths: Standard width of .750 inches and Narrow width of .680 inches. The plates will be available in two lordotic curve geometries. The Cervical Screws are cancellous bone screws. The screw locking means is assembled to the plate during the manufacturing process.

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### Intended Use

The Spinal Innovations SPECTRUM™ Cervical Spinal System is intended for anterior intervertebral body screw fixation of the cervical spine. The system implants are indicated for use in the temporary stabilization of the anterior spine during the development of cervical spine fusions in patients with degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures or dislocation), tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudoarthrosis, and/or failed previous fusions.

Warning: This device is not approved for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.

#### Testing

Biomechanical testing demonstrated that the components of the Spinal Innovations SPECTRUM™ Cervical Spinal System exhibit equivalent mechanical performance, compared to predicate devices.

#### Basis for Substantial Equivalence

The Spinal Innovations SPECTRUM™ Cervical Spinal System is substantially equivalent in material, design and function to the predicate devices.

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

0 6 2002

Mr. Joseph S. Clift Vice President, Regulatory Affairs Spinal Innovations. Inc. 7850 Stage Hill Blvd Suite 105 Bartlett, Tennessee 38133

K022997 Re:

> Trade Name: SPECTRUM™ Cervical Spinal System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal Intervertebral Fixation Orthosis Regulatory Class: II Product Code: KWO Dated: September 6, 2002 Received: September 9, 2002

Dear Mr. Clift:

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. Iisting 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. Joseph S. Clift

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsmamain.html.

Sincerely yours,

O Mark M. Millan

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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#### K022997 510(K) Number

Device Name: Spinal Innovations SPECTRUM™ Cervical Spinal System.

#### Indications for Use:

The Spinal Innovations SPECTRUM TM Cervical Spinal System is intended for anterior intervertebral body screw fixation of the cervical spine. The system implants are indicated for use in the temporary stabilization of the anterior spine during the development of cervical spine fusions in patients with degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures or dislocation), tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudoarthrosis, and/or failed previous fusions.

Warning: This device is not approved for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.

for
(Division Sign-Off)

Mark N. Milliman

Division of General, Restorative and Neurological Devices

510(k) Number K022997

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (per 21 CFR 801.109) OR

Over-The-Counter Use

(Optional Format 1-2-96)