SPINAL CONCEPTS INC. CODA

K033663 · Spinal Concepts, Inc. · MQP · May 27, 2004 · Orthopedic

Device Facts

• Record ID: K033663
• Device Name: SPINAL CONCEPTS INC. CODA
• Applicant: Spinal Concepts, Inc.
• Product Code: MQP · Orthopedic
• Decision Date: May 27, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Coda 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). Coda 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. Coda is intended to be used with bone graft and supplemental fixation. Additionally, Coda is intended to be implanted in a paired configuration.

Device Story

Coda is a vertebral body replacement implant; manufactured from titanium 6AL-4V alloy. Device features two opposing surfaces for contact with vertebral endplates; adjustable to provide 0-11 degrees of lordosis. Available in various lengths, widths, and heights for anatomic flexibility. Implanted by surgeons in a paired configuration; used in conjunction with bone graft and supplemental fixation. Restores biomechanical integrity of anterior, middle, and posterior spinal columns following vertebrectomy. Mechanical testing confirms ability to support normal physiologic spinal loads.

Clinical Evidence

Bench testing only; no clinical data provided. Mechanical testing demonstrated that the device exhibits the functional requirements to support its use as a vertebral body replacement under normal physiologic loads in the spine.

Technological Characteristics

Material: Implantable grade titanium 6AL-4V alloy (ASTM F-136). Form factor: Two-surface adjustable implant for vertebral body replacement. Adjustability: 0-11 degrees of lordosis. Configuration: Paired implantation. Energy source: None (mechanical). Connectivity: None.

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).

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

• SIGNUS TETRIS Spinal Implant (K022793, K031757)

Submission Summary (Full Text)

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## 510(K) Summary

| Submitted By: | Lisa Peterson |
|----------------------|--------------------------------|
| | Regulatory Affairs Specialist |
| | Spinal Concepts, Inc. |
| | 5301 Riata Park Court, Bldg. E |
| | Austin, TX 78727 |
| | 512-918-2700 |
| Date: | November 20, 2003 |
| Trade Name: | Spinal Concepts Inc. Coda® |
| Classification Name: | Vertebral Body Replacement |
| Product Code: | MOP |

Predicate Devices: Coda® is substantially equivalent to the SIGNUS TETRIS™ Spinal Implant, which was cleared for use as a vertebral body replacement device via K022793 (titanium version) and K031757 (PEEK version).

Device Description: Coda is manufactured from implantable grade titanium 6AL-4V alloy that conforms to ASTM F-136. The device consists of two opposing surfaces that make contact with the bony endplates of the vertebral bodies, and can be adjusted to provide from 0-11 degrees of fordosis.

Coda is available in two lengths and widths, and in various heights to provide the surgeon anatomic flexibility.

Coda is a vertebral body replacement device that is intended for use in the Intended Use: 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).

Coda 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. Coda is intended to be used with bone graft and supplemental fixation. Additionally, Coda is intended to be implanted in a paired configuration.

Substantial Equivalence: Mcchanical testing demonstrated that Coda® exhibits the functional requirements to support its use as vertebral body replacement under normal physiologic loads in the spine.

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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features the department's name encircling an emblem. The emblem consists of a stylized caduceus, a symbol often associated with medicine and healthcare, with three parallel lines representing the branches of the department.

Public Health Service

MAY 27 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K033663

> Trade Name: CODA® Vertebral Body Replacement Device Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Codc: MQP Dated: March 12, 2004 Received: March 15, 2004

Dear Ms. Peterson:

We have reviewed your Scction 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 practicc 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 promance device results in a classification for your device and thus, permits your device to proceed to the rearkat.

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, "Misbrang 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,

Mark N. Millenson

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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Page 1 of 1

510(k) Number (if known): 14 - C 3 77 3 6

Device Name:

Spinal Concepts, Inc. Coda®

Indications for Use:

Coda is a vertebral body replacement device 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).

Coda 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.

Coda is intended to be used with bone graft and supplemental fixation. Additionally, Coda is intended to be implanted in a paired configuration.

part II Immigration.

Division of General, Restorative, and Neurological Devices

**510(k) Number** K033663

(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)