STAXX(R) XD SYSTEM

K111418 · Spine Wave, Inc. · MQP · Dec 13, 2011 · Orthopedic

Device Facts

• Record ID: K111418
• Device Name: STAXX(R) XD SYSTEM
• Applicant: Spine Wave, Inc.
• Product Code: MQP · Orthopedic
• Decision Date: Dec 13, 2011
• 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; adjusts height of collapsed/damaged/unstable vertebral bodies. Components manufactured from PEEK-OPTIMA with 6% Barium Sulfate; includes tantalum markers for fluoroscopic visualization. Delivered and expanded via manual Surgical Gun. Used in thoracolumbar spine (T1-L5); placed bilaterally; requires supplemental fixation (CapSure® PS Spine System) and bone graft (autograft/allograft). Benefits patient by restoring vertebral height and stability following tumor or trauma.

Clinical Evidence

Bench testing only. Finite Element Analysis performed to demonstrate substantial equivalence to predicate devices.

Technological Characteristics

Expandable vertebral body replacement implant; stackable wafer design. Materials: PEEK-OPTIMA with 6% Barium Sulfate; tantalum markers. Manual delivery/expansion via Surgical Gun. No software or energy source.

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 (K101288)
• StaXx® XD System (K102682)

Reference Devices

• CapSure® PS Spine System

Submission Summary (Full Text)

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# 510(k) Summary StaXx® XD System

#### 1. Submitter Information

| Submitter: | Spine Wave, Inc. |
|----------------|------------------------|
| Address: | Three Enterprise Drive |
| | Suite 210 |
| | Shelton, CT 06484 |
| Telephone: | 203-712-1839 |
| Telefax: | 203-944-9493 |
| Contact: | Roaida Rizkallah |
| Date Prepared: | November 1, 2011 |

#### 2. Device Information

Trade Name: Common Name: Classification Name: Classification/Code:

StaXx® XD System Vertebral 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 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 predicates:

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

## 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 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 (TI-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

Finite Element Analysis was performed to demonstrate that the subject StaXx XD System is substantially equivalent to the listed predicate devices.

### 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 lines forming its body and wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is 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

DEC 1 3 2011

Spine Wave, Inc. % Ms. Roaida Rizkallah Three Enterprise Drive, Suite 210 Shelton, Connecticut 06484

Re: K111418

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: November 01, 2011 Received: November 02, 2011

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

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Page 2 - Ms. Roaida Rizkallah

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/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,
Erinl Keith

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): _杉川 418

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)

Rishabh Shah, MD

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

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KI11418 510(k) Number_