STAXX XD SYSTEM

K090315 · Spine Wave, Inc. · MQP · Sep 3, 2009 · Orthopedic

Device Facts

• Record ID: K090315
• Device Name: STAXX XD SYSTEM
• Applicant: Spine Wave, Inc.
• Product Code: MQP · Orthopedic
• Decision Date: Sep 3, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The StaXx® XD System is a vertebral body replacement device intended for use in the thoracolumbar spine (T1-L5) to replace and restore height of a collapsed, damaged, or unstable vertebral body or portion thereof, due to tumor or trauma (i.e., fracture). The system is to be placed bilaterally and used with autograft or allograft and supplemental spinal fixation. The supplemental fixation system that is intended to be used with the StaXx® XD System is the CapSure® PS Spine System.

Device Story

Vertebral body replacement system; consists of stackable wafers forming expandable implant; used to restore height in thoracolumbar spine (T1-L5). Implanted via specialized delivery device; placed bilaterally; requires concurrent use of autograft/allograft and supplemental spinal fixation (CapSure® PS Spine System). Used by surgeons in clinical/OR settings. Provides structural support to damaged/unstable vertebrae; benefits patient by restoring spinal column height and stability.

Clinical Evidence

Bench testing only.

Technological Characteristics

Implant material: PEEK-OPTIMA with 6% Barium Sulfate. Expandable design using stackable wafers. Sizes: 7mm to 30mm. Includes delivery device for implantation and expansion. Mechanical fixation via supplemental system.

Indications for Use

Indicated for patients with collapsed, damaged, or unstable vertebral bodies in the thoracolumbar spine (T1-L5) resulting from tumor or trauma (fracture). Requires use with autograft or allograft and supplemental spinal 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

• StaXx® XD System (K052670)

Submission Summary (Full Text)

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K090315
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SFP - 8 2009

# 510(k) Summary StaXx® XD System

## Submitter Information

Spine Wave, Inc. Three Enterprise Drive Suite 210 Shelton, CT 06484 203-712-1839 Telephone: [phone] Telefax:

Contact: Date Prepared: Roaida Rizkallah August 26, 2009

#### Device Information

Trade name: Common name: Classification: Product Code:

StaXx® XD System Vertebral Body Replacement Class II per 21 CFR 888.3070 Classification Name: Spinal Intervertebral Body Fixation Orthosis MQP

## Device Description

The StaXx® XD System is a vertebral body replacement device composed of wafers that are stacked into an expandable implant to adjust its height. The implant components are manufactured from PEEK-OPTIMA with 6% Barium Sulfate. The system also includes a delivery device to implant and expand the implant. The device is offered in sizes ranging from 7mm to 30mm.

#### Intended Use

The StaXx® XD System is a vertebral body replacement device intended for use in the thoracolumbar spine (T1-L5) to replace and restore height of a collapsed, damaged, or unstable vertebral body or portion thereof, due to tumor or trauma (i.e., fracture). The system is to be placed bilaterally and used with autograft or allograft and supplemental spinal fixation. The supplemental fixation system that is intended to be used with the StaXx® XD System is the CapSure® PS Spine System.

Three Enterprise Drive • Suite 210 • Shelton, CT 06484 • Tcl: 203-944-9494 • Fax: [phone] • www.spinewave.com

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# Substantial equivalence

The StaXx® XD System described in this submission is substantially equivalent to the following device:

| Status Market Company Company Company Company Company Company Company Company Company Company Company Company Company Company Company Company Company Company Company Company<br>Predicate Device | of the Lammer a second a super-<br>Manufacturer | 510(k) No. |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------|------------|
| StaXx® XD System | Spine Wave, Inc. | K052670 |

In addition, mechanical testing demonstrated that the StaXx® XD System is equivalent to its predicate device. The minor differences between the StaXx® XD System and the predicate device do not raise any new questions of safety or effectiveness. Thus, the StaXx® XD System is substantially equivalent to its predicate device.

ﻣﺴﻤﺴ ﻣ

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles an abstract human figure.

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002

Spine Wave, Inc. % Ms. Roaida Rizkallah Senior Regulatory Affairs Specialist 2 Enterprise Drive, Suite 210 Shelton, Connecticut 06484

SEP - 3 2009

Re: K090315

Trade/Device Name: StaXx® XD System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: MQP Dated: August 26, 2009 Received: August 31, 2009

Dear Ms. Rizkallah:

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 aboye) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting of medical device-related adverse events) (21 CFR 803); 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. Roaida Rizkallah

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

for

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

Enclosure

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K090315 510(k) Number (if known): ___

StaXx® XD System Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications for Use:

The StaXx® XD System is a vertebral body replacement device intended for use in the thoracolumbar spine (T1-L5) to replace and restore height of a collapsed, damaged, or unstable vertebral body or portion thereof, due to tumor or trauma (i.e., fracture). The system is to be placed bilaterally and used with autograft or allograft and supplemental spinal fixation. The supplemental fixation system that is intended to be used with the StaXx® XD System is the CapSure® PS Spine System.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Kareem S. Boney for MXM
(Division Sign-Off)

Division of Surgical, Orthopedic, and Restorative Devices

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510(k) Number K090315