FORTITUDE VUE VERTEBRAL BODY REPLACEMENT DEVICE

K051000 · Spinal Concepts, Inc. · MQP · May 19, 2005 · Orthopedic

Device Facts

• Record ID: K051000
• Device Name: FORTITUDE VUE VERTEBRAL BODY REPLACEMENT DEVICE
• Applicant: Spinal Concepts, Inc.
• Product Code: MQP · Orthopedic
• Decision Date: May 19, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Fortitude Vue is a vertebral body replacement device that is intended for use in the thoracic and/or thoracolumbar spine (T3 - L5) to replace a collapsed, damaged or unstable vertebral body resected or excised (i.e., partial or total vertebrectomy procedures) due to tumor or trauma (i.e., fracture). Fortitude Vue is designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column even in the absence of fusion for a prolonged period. Fortitude Vue is intended to be used with bone graft.

Device Story

Fortitude Vue is a hollow spinal intervertebral body fixation orthosis; used to replace collapsed, damaged, or unstable vertebral bodies in the thoracic/thoracolumbar spine (T3-L5). Device restores biomechanical integrity of the anterior, middle, and posterior spinal column; intended for use with bone graft. Operated by surgeons in a clinical/surgical setting. Subject device represents a material change and minor design modifications to the predicate.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Hollow vertebral body replacement device; metallic construction (material change from predicate). Designed for thoracic/thoracolumbar spinal fixation. Standalone mechanical implant.

Indications for Use

Indicated for patients requiring vertebral body replacement in the thoracic and/or thoracolumbar spine (T3-L5) following partial or total vertebrectomy due to tumor or trauma (fracture). Intended for use with bone graft.

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

• Fortitude™ Titanium manufactured by Spinal Concepts Inc., K031914

Submission Summary (Full Text)

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051000

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## SPINAL CONCEPTS INC. SUMMARY OF SAFETY AND EFFECTIVENESS

.

.

# MAY 1 9 2005

| SUBMITTER: | Spinal Concepts, Inc. (an Abbott Laboratories Company) |
|------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| ESTABLISHMENT REGISTRATION NUMBER: | 1649384 |
| CONTACT PERSON: | Noah Bartsch |
| | Specialist, Regulatory Affairs |
| Telephone: | 512.533.1840 |
| Fax: | 512.918.2784 |
| DATE: | April 19, 2005 |
| TRADE NAME: | Fortitude™ Vue Vertebral Body Replacement Device |
| PRODUCT CODE: | MQP |
| CLASSIFICATION NAME: | Spinal Vertebral Body Replacement Device |
| CLASSIFICATION REFERENCE: | 21 CFR § 888.3060 |
| PREDICATE DEVICE: | Fortitude™ Titanium manufactured by Spinal Concepts Inc., K031914, cleared August 12, 2003. |
| DEVICE DESCRIPTION: | Fortitude Vue is a hollow device intended for use as a spinal intervertebral body fixation orthosis. |
| INDICATIONS: | Fortitude Vue is a vertebral body replacement device that is intended for use in the thoracic and/or thoracolumbar spine (T3 - L5) to replace a collapsed, damaged or unstable vertebral body resected or excised (i.e., partial or total vertebrectomy procedures) due to tumor or trauma (i.e., fracture). Fortitude Vue is designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column even in the absence of fusion for a prolonged period. Fortitude Vue is intended to be used with bone graft. |

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COMPARISON TO PREDICATE DEVICE:

Fortitude Vue is substantially equivalent in design to the predicate device, and has the same intended use. The subject device is the result of a material change and minor design modifications to the predicate.

PERFORMANCE DATA (NONCLINICAL AND/OR CLINICAL):

Non-Clinical Performance and Conclusions:

Laboratory and bench testing results demonstrate that the proposed Fortitude Vue is substantially equivalent to the predicate device.

Clinical Performance and Conclusions:

Clinical data and conclusions were not needed for this device.

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Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 1 9 2005

Mr. Noah Bartsch Regulatory Affairs Specialist Spinal Concepts Incorporated 5301 Riata Park Court, Bldg. F Austin, Texas 78727

Re: K051000

ﭘ Trade Name: Fortitude™ Vue VBR System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: MQP Dated: April 19, 2005 Received: April 20, 2005

Dear Mr. Bartsch:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use surfal to May 28, 1976, the enactment date of the Medical Device Amendments, or to conninered prox to they 2018 sified in accordance with the provisions of the Federal Food, Drug, de necs that have been reciase at require approval of a premarket approval application (PMA). and Cosmetic Act (71ct) that to nevice, subject to the general controls provisions of the Act. The r ou may, mererere, mains of the Act include requirements for annual registration, listing of general of the brown of active, 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 If your device is elassinod (ontrols. Existing major regulations affecting your device can may be subject to such additional controllations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 – Mr. Noah Bartsch

Please be advised that FDA's issuance of a substantial equivalence determination does not mean I lease be devilsed that I DF o lessan that your device complies with other requirements of the Act that I Dr I has intes and regulations administered by other Federal agencies. You must or any I 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 Of R rate 6077, accems (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. product radiation of to begin marketing your device as described in your Section 510(k) I mis lotter will and in your e FDA finding of substantial equivalence of your device to a legally premation holicated. " 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 Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general mixermational 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,

Hyat Ruvda

Miriam Provost, Ph.D. Acting 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

KASIOOO 510(k) Number (if known):

#### Device Name:

Spinal Concepts Inc. Fortitude™ Vue Vertebral Body Replacement System

#### Indications for Use:

Fortitude Vue is a vertebral body replacement device that is intended for use in the thoracic and/or thoracolumbar spine (T3 - L5) to replace a collapsed, damaged or unstable vertebral and/or thoracolumbal spile (15 - E3) to replace a vertebrectomy procedures) due to tumor or body resected or exclude (ite), partial es designed to restore the biomechanical integrity of the trauna (f.e., Hucture). Tornale in as solumn even in the absence of fusion for a prolonged period. Fortitude Vue is intended to be used with bone graft.

Prescription Use __X_ (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use _ (21 CFR 807 Subpart C)

(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 | K051000 |
|---------------|---------|
|---------------|---------|

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