STAXX XD SYSTEM

K121889 · Spine Wave, Inc. · MQP · Aug 29, 2012 · Orthopedic

Device Facts

• Record ID: K121889
• Device Name: STAXX XD SYSTEM
• Applicant: Spine Wave, Inc.
• Product Code: MQP · Orthopedic
• Decision Date: Aug 29, 2012
• 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

Vertebral body replacement system; consists of stackable wafers forming expandable implant; used to restore height in thoracolumbar spine (T1-L5). Implant components made of PEEK-OPTIMA with 6% Barium Sulfate; includes tantalum markers for fluoroscopic visualization. System includes Surgical Gun delivery device for placement and expansion. Used by surgeons in clinical/OR settings. Output is physical structural support for vertebral body; aids in stabilization of damaged/unstable segments. Benefits patient by restoring spinal height and structural integrity following tumor or trauma.

Clinical Evidence

Bench testing only. Dynamic axial compression testing performed according to ASTM F2077 to demonstrate substantial equivalence to the predicate device.

Technological Characteristics

Materials: PEEK-OPTIMA with 6% Barium Sulfate; tantalum markers. Principle: Stackable wafer-based expandable implant. Delivery: Surgical Gun. Testing: ASTM F2077 dynamic axial compression. Connectivity: None. Sterilization: Not specified.

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 (CapSure® PS Spine System).

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 (K102682, K111418)

Reference Devices

• CapSure® PS Spine System

Submission Summary (Full Text)

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# SPINE WAVE

AUG 2 9 2012

. ﻳ

# 510(k) Summary StaXx® XD System

### 1. Submitter Information

| Submitter: | Spine Wave, Inc. |
|------------|----------------------------------------------------------|
| Address: | Three Enterprise Drive<br>Suite 210<br>Shelton, CT 06484 |
| Telephone: | 203-712-1839 |
| Telefax: | 203-944-9493 |
| Contact: | Roaida Rizkallah |

Date Prepared: August 16, 2012

#### 2. Device Information

| Trade Name: | StaXx® XD System |
|----------------------|----------------------------------------------|
| Common Name: | Vertebral Body Replacement |
| Classification Name: | Spinal Intervertebral Body Fixation Orthosis |
| Classification/Code: | Class II per 21 CFR 888.3060; MQP |

#### 3. Purpose of Submission

The purpose of this submission is to gain clearance to expand the StaXx® XD System offering to include additional sizes.

#### 4. Predicate Device Information

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

| Predicate Device | Manufacturer | 510(k) No. |
|-------------------|------------------|---------------------|
| StaXx ® XD System | Spine Wave, Inc. | K102682,<br>K111418 |

#### Device Description 5.

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 contain tantalum markers for additional visualization under fluoroscopy. The system also includes the Surgical Gun, a delivery device to place and expand the system.

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#### 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.

#### 8. Performance Data

Dynamic axial compression testing according to ASTM F2077 was performed to demonstrate that the modified StaXx® XD System is substantially equivalent to the predicate StaXx® XD System.

#### 9. Conclusion

Based on the indications for use, technological characteristics, performance testing and comparison to a predicate, 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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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle.

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

Spinewave, Incorporporated % Ms. Roaida Rizkallah Regulatory Affairs Manager Three Enterprise Drive, Suite 210 Shelton, Connecticut 06484

Re: K121889

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: MQP Dated: August 16, 2012 Received: August 17, 2012

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. 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 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

AUG 2 9 2012

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Page 2 - Ms. Roaida Rizkallah

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.

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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Mark A. Mellema

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):

Device Name:

StaXx® XD System

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)

Carl-Ry

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

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510(k) Number k121889

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