STAXXSD SYSTEM

K111469 · Spine Wave, Inc. · MQP · Jul 19, 2011 · Orthopedic

Device Facts

• Record ID: K111469
• Device Name: STAXXSD SYSTEM
• Applicant: Spine Wave, Inc.
• Product Code: MQP · Orthopedic
• Decision Date: Jul 19, 2011
• Decision: SESE
• Submission Type: Special
• 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

StaXx® XD System is a vertebral body replacement device consisting of stackable wafers used to adjust implant height. Implant components are manufactured from PEEK-OPTIMA with 6% Barium Sulfate and may include tantalum markers for fluoroscopic visualization. The system is delivered via a surgical gun. It is intended for use in the thoracolumbar spine (T1-L5) to replace and restore height of collapsed, damaged, or unstable vertebral bodies due to tumor or trauma. The device is placed bilaterally in conjunction with autograft or allograft and the CapSure® PS Spine System for supplemental fixation. The system is used by surgeons in a clinical/surgical setting.

Clinical Evidence

No clinical data. Substantial equivalence demonstrated via non-clinical performance testing and comparison to predicate devices.

Technological Characteristics

Vertebral body replacement system composed of stackable wafers. Materials: PEEK-OPTIMA with 6% Barium Sulfate; optional tantalum markers. Mechanical expansion mechanism. Used with supplemental spinal fixation (CapSure® PS Spine System).

Indications for Use

Indicated for patients with collapsed, damaged, or unstable vertebral bodies (T1-L5) due to tumor or trauma (fracture) requiring height restoration. Used bilaterally 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)
• StaXx® XD System (K090315)
• StaXx® XD System (K101288)
• StaXx® XD System (K102682)

Reference Devices

• CapSure® PS Spine System

Submission Summary (Full Text)

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JUL 19 2011

# 510(k) Summary StaXx® XD System Surgical Gun

## 1. Submitter Information

| Submitter: | Spine Wave, Inc. |
|----------------|----------------------------------------------------------|
| Address: | Three Enterprise Drive<br>Suite 210<br>Shelton, CT 06484 |
| Telephone: | 203-712-1847 |
| Telefax: | 203-944-9493 |
| Contact: | Denise Duchene |
| Date Prepared: | June 30, 2011 |

## 2. Device Information

| Trade Name: | S |
|----------------------|---|
| Common Name: | V |
| Classification Name: | S |
| Classification/Code: | C |

StaXx® XD System /ertebral Body Replacement Spinal Intervertebral Body Fixation Orthosis Class II per 21 CFR 888.3060; MQP

## 3. Purpose of Submission

The purpose of this submission is to describe a modification to the labeling for the StaXx® XD System. In addition minor modifications have been made to the surgical gun used to deliver the StaXx® XD Expandable Device.

## 4. Predicate Device Information

The StaXx® XD System described in this submission is substantially equivalent to StaXx® XD System included in the following 510(k)s:

| Predicate Device | Manufacturer | 510(k) No. |
|------------------|------------------|------------|
| StaXx® XD System | Spine Wave, Inc. | K052670 |
| StaXx® XD System | Spine Wave, Inc. | K090315 |
| StaXx® XD System | Spine Wave, Inc. | K101288 |
| StaXx® XD System | Spine Wave, Inc. | K102682 |

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## 5. Device Description

The StaXx® XD System is composed of wafers that are stacked into an expandable implant to adjust the height of the implant. The implant components are manufactured from PEEK-OPTIMA with 6% Barium Sulfate and may contain tantalum markers for additional visualization under fluoroscopy.

## 6. 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.

## 7. Comparison of Technological Characteristics

The substantial equivalence of the subject StaXx® XD System is shown by similarity in intended use, indications for use, materials and performance to the cited predicate device. The StaXx® XD System and the predicate devices are manufactured from the same materials and have the same indications and technological characteristics.

## 8. Performance Data

Non-clinical testing was performed to demonstrate that the subject StaXx® XD System is substantially equivalent to the listed predicate device. No testing is required for an update to the labeling.

## 9. Conclusion

Based on the indications for use, technological characteristics, performance testing and comparison to predicates, the subject StaXx® XD System has been shown to be substantially equivalent to the predicate device identified in this submission, and does not present any new issues of safety or effectiveness.

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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 stylized eagle with three wavy lines representing its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular fashion around the eagle.

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

Spine Wave, Inc. % Ms. Denise Duchene Sr. Manager, Regulatory Affairs Three Enterprise Drive, Suite 210 Shelton, Connecticut 06484

JUL 19 2011

Re: K111469

Trade/Device Name: StaXx® XD System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis -Regulatory Class: Class II Product Code: MOP Dated: June 30, 2011 Received: July 01, 2011

Dear Ms. Duchene:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

If your device is classified (see above) 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

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Page 2 - Ms. Denise Duchene

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 (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.

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/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.

erely yours,

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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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)

(Division Sign Off)

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(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number_________________________________________________________________________________________________________________________________________________________________