SPINAL CONCEPTS, INC. CADENCE AND FORTITUDE

K031914 · Spinal Concepts, Inc. · MQP · Jul 12, 2003 · Orthopedic

Device Facts

• Record ID: K031914
• Device Name: SPINAL CONCEPTS, INC. CADENCE AND FORTITUDE
• Applicant: Spinal Concepts, Inc.
• Product Code: MQP · Orthopedic
• Decision Date: Jul 12, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Cadence and Fortitude are vertebral body replacement devices that are 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). These devices are designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column even in the absence of fusion for a prolonged period. These devices are intended to be used with bone graft.

Device Story

Cadence and Fortitude are hollow vertebral body replacement (VBR) devices; used to restore biomechanical integrity of anterior, middle, and posterior spinal columns following vertebrectomy. Devices feature textured opposing flat sides; Cadence offered in tapered styles; Fortitude offered in straight and tapered styles. Intended for use in thoracic/thoracolumbar spine (T3-L5) with bone graft. Operated by surgeons in clinical settings.

Clinical Evidence

Bench testing only. Mechanical testing demonstrated that the devices exhibit the functional requirements to support their use as vertebral body replacements under normal physiologic loads in the spine.

Technological Characteristics

Materials: Titanium alloy (ASTM F136). Design: Hollow, textured opposing flat sides; straight and tapered styles. Energy source: None (mechanical implant). Connectivity: None. Sterilization: Not specified.

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

• Interpore Cross GEO Structure (K010530, K020048)
• DePuy AcroMed Stackable Cage System (K001340)

Submission Summary (Full Text)

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AUG 1 2 2003

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## 510(K) Summary

| Submitted By: | Lisa Peterson<br>Regulatory Affairs Specialist<br>Spinal Concepts, Inc.<br>5301 Riata Park Court, Bldg. F<br>Austin, TX 78727<br>512-918-2700<br>June 19, 2003 |
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| Trade Name: | Spinal Concepts Inc. CadenceTM and FortitudeTM |
| Classification Name: | Vertebral Body Replacement |

Product Code: MOP

Vertebral Body Replacement

Predicate Devices: Cadence™ and Fortitude™ are substantially equivalent to the Interpore Cross GEO™ Structure, which was cleared as an oval shaped configuration on August 3, 2001 (K010530) and as a rectangular shaped configuration on February 6, 2002 (K020048), and to the DePuy AcroMed Stackable Cage™ System cleared on July 26, 2000 (K001340).

Device Description: Cadence™ is a hollow device with texture on two opposing flat sides. The device is crafted titanium alloy (ASTM F136) and is offered in a tapered style of various sizes.

Fortitude™ is a hollow device with texture on two opposing flat sides. The device is crafted from titanium alloy (ASTM F136) and is offered in straight and tapered styles of various sizes.

Intended Use: Cadence and Fortitude are vertebral body replacement devices that are 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). These devices are designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column even in the absence of fusion for a prolonged period. These devices are intended to be used with bone graft.

Mechanical Testing: Mechanical testing demonstrated that Cadence™ and Fortitude™ exhibit the functional requirements to support their use as vertebral body replacements under normal physiologic loads in the spine.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the edge. In the center of the seal is an abstract image of a bird-like figure with three lines forming the body and two wavy lines forming the legs. There is a small star above the bird-like figure.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 1 2 2003

Ms. Lisa Peterson Regulatory Affairs Specialist Spinal Concepts Incorporated 5301 Riata Park Court, Bldg. F Austin, Texas 78727

> K031914 Trade Name: Cadence™ and Fortitude™ VBR Systems Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: MOP Dated: June 19, 2003 Received: June 26, 2003

Dear Ms. Peterson:

Re:

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 - Ms. Lisa Peterson

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 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 Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Celia M. Witten, Ph.D., M.D.

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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## INDICATIONS FOR USE STATEMENT

Page 1 of 1

KO31 914 510(k) Number (if known):

Device Name:

## Spinal Concepts, Inc. Cadence™ and Fortitude™

Indications for Use:

Cadence and Fortitude are vertebral body replacement devices that are 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). These devices are designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column even in the absence of fusion for a prolonged period. These devices are intended to be used with bone graft.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use: (Per 21 CFR 801.109)

OR

Over-The-Counter: (Optional Format 1-2-96)

Dision of General, Restorative and Neurolog

) Number /C0319/4