PHENIX VERTEBRAL BODY REPLACEMENT

K072029 · New Business Development, LLC · MQP · Oct 15, 2007 · Orthopedic

Device Facts

• Record ID: K072029
• Device Name: PHENIX VERTEBRAL BODY REPLACEMENT
• Applicant: New Business Development, LLC
• Product Code: MQP · Orthopedic
• Decision Date: Oct 15, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Phenix™ VBR is a vertebral body replacement device intended for use in the thoracic spine (i.e., T1-L5) to replace a collapsed, damaged or unstable vertebral body resected or excised (i.e., partial or total vertebrectomy) due to tumor or trauma (i.e., fracture). The Phenix™ VBR is designed to restore the mechanical integrity of the anterior, middle and posterior spinal column even in the absence of fusion for a prolonged period. The Phenix™ VBR is intended for use with supplemental spinal fixation systems that have been labeled for use in the thoracic spine. The interior of the Phenix™ VBR may be packed with bone graft.

Device Story

Phenix™ VBR is a rectangular, open-center titanium (Ti-6Al-4V) implant; designed for surgical replacement of collapsed, damaged, or unstable vertebral bodies in thoracic spine (T1-L5). Features superior/inferior ridges to interface with vertebral endplates; resists rotation and migration. Available in various sizes, including flat and lordotic angles to accommodate patient anatomy. Implanted by surgeons during vertebrectomy procedures; interior may be packed with autograft bone to facilitate healing. Functions as a structural spacer to restore mechanical integrity of anterior, middle, and posterior spinal columns; requires use with supplemental spinal fixation systems. Titanium material allows for radiographic visualization post-implantation.

Clinical Evidence

Bench testing only.

Technological Characteristics

Material: Titanium (Ti-6Al-4V). Form factor: Rectangular implant with open center and ridged superior/inferior surfaces. Variants: Flat and lordotic angled options. Radiographic visualization supported by titanium construction. No software or electronic components.

Indications for Use

Indicated for patients requiring vertebral body replacement in the thoracic spine (T1-L5) following partial or total vertebrectomy due to tumor or trauma (fracture). Intended for use with supplemental spinal fixation systems.

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.

Submission Summary (Full Text)

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Phenix™ Vertebral Body Replacement 510(k) Application

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| Company:<br>Company Name<br>Street address<br>City, State Zip Code<br>Telephone | Spinal Devices, LLC<br>1155 Allgood Road, Suite 6<br>Marietta, GA 30062<br>770-874-0935 | UC |
|---------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----|
| Company Contact: | Tim Lusby | |
| Common Name | Spinal vertebral body replacement device | |
| Trade Name: | Phenix™ VBR | |
| Classification: | Class II | |
| Product Code; | MQP, 888.3060 | |
| Device Description: | The Phenix™ VBR is a rectangular implant with an<br>open center comprised of titanium, (Ti-6Al-4V). The<br>Phenix™ VBR's superior and inferior ends have<br>ridges to interface with the vertebral endplates to<br>resist rotation and migration. The implant is available<br>in a range of sizes, as well as flat and lordotic angled<br>implants to accommodate variations in patient's<br>anatomy. The Titanium allows for radiographic<br>visualization. | |
| Intended Use: | The Phenix™ VBR is a vertebral body replacement<br>device intended for use in the thoracic spine (i.e., T1-<br>L5) to replace a collapsed, damaged or unstable<br>vertebral body resected or excised (i.e., partial or total<br>vertebrectomy) due to tumor or trauma (i.e., fracture).<br>The Phenix™ VBR is designed to restore the<br>mechanical integrity of the anterior, middle and<br>posterior spinal column even in the absence of fusion<br>for a prolonged period. The Phenix™ VBR is intended<br>for use with supplemental spinal fixation systems that<br>have been labeled for use in the thoracic spine. The<br>interior of the Phenix™ VBR may be packed with bone<br>graft. | |
| Predicate Device: | Based on the same indications for use, intended use,<br>design and performance to the predicate device,<br>substantial equivalence was determined. | |
| Performance Data: | Testing was completed to characterize the device. | |

16072029

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Image /page/1/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 its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular pattern around the eagle. The logo is black and white and appears to be a simple, official design.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

New Business Development, LLC % Mr. Tim Lusby General Manager, Member 1155 Allgood Road, Suite 6 Marietta, Georgia 30062

OCT 1 5 2007

K072029 Trade/Device Name: Phenix Vertebral Body Replacement Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: MQP Dated: August 31, 2007 Received: September 4, 2007

Dear Mr. Lusby:

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 - Mr. Tim Lusby

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number [phone] or [phone] or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Barbara Buchur

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

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## Indication for Use Statement

510(k) Number (if known): K072029

Device Name: Phenix™ Vertebral Body Replacement

Indications for Use:

The Phenix™ VBR is a vertebral body replacement device intended for use in the thoracic spine (i.e., T1-L5) to replace a collapsed, damaged or unstable vertebral body resected or excised (i.e., partial or total vertebrectomy) due to tumor or trauma (i.e., fracture). The Phenix™ VBR is designed to restore the mechanical integrity of the anterior, middle and posterior spinal column even in moshanisal intogray of the prolonged period. The Phenix™ VBR is intended for use with supplemental spinal fixation systems which are labeled for use in the thoracic spine. The interior of the Phenix™ VBR may be packed with autograft bone.

Prescription Use X Over-The-Counter Use

(21 CFR 801 Subpart D)

(21 CFR 807 Subpart C)

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

or

Concurrence of CDRH, Office of Device Evaluation (ODE)

Barbara BuchR

1. Restorative, and Neurological Devices

**510(k) Number:** K072029