MODIFICATION TO STAXX FX SYSTEM

K063606 · Spine Wave, Inc. · OBL · Apr 13, 2007 · Orthopedic

Device Facts

• Record ID: K063606
• Device Name: MODIFICATION TO STAXX FX SYSTEM
• Applicant: Spine Wave, Inc.
• Product Code: OBL · Orthopedic
• Decision Date: Apr 13, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3027
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The StaXx™ FX System is indicated for use in the reduction of spinal fractures. It is intended to be used in combination with Stryker Spineplex™ Radiopaque Bone Cement.

Device Story

StaXx™ FX System is an internal fracture reduction device; consists of base wafer and stackable wafers; fabricated from PEEK-OPTIMA with 6% Barium Sulfate. Wafers inserted incrementally into vertebral body to form column for fracture reduction. Used by surgeons in clinical setting. System provides mechanical support for fracture reduction; used in combination with Stryker Spineplex™ Radiopaque Bone Cement. Benefits include restoration of vertebral height through controlled, incremental stacking of wafers.

Clinical Evidence

Bench testing only; no clinical data provided.

Technological Characteristics

Vertebral fracture reduction system; components: base wafer and stackable wafers. Material: PEEK-OPTIMA with 6% Barium Sulfate (BaSO4). Dimensions: 8mm width; 20mm, 25mm, 30mm lengths. Manual surgical instrument; non-powered; non-software.

Indications for Use

Indicated for the reduction of spinal fractures in patients requiring vertebral fracture reduction. Intended for use with Stryker Spineplex™ Radiopaque Bone Cement.

Regulatory Classification

Identification

Polymethylmethacrylate (PMMA) bone cement is a device intended to be implanted that is made from methylmethacrylate, polymethylmethacrylate, esters of methacrylic acid, or copolymers containing polymethylmethacrylate and polystyrene. The device is intended for use in arthroplastic procedures of the hip, knee, and other joints for the fixation of polymer or metallic prosthetic implants to living bone.

Special Controls

*Classification.* Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Polymethylmethacrylate (PMMA) Bone Cement.”

Predicate Devices

• StaXx™ FX System (K053336)

Submission Summary (Full Text)

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K063606

APR 1 3 2007

# 510(k) Summary StaXx™ FX System

### Submitter Information

Spine Wave, Inc. Two Enterprise Drive Suite 302 Shelton, CT 06484 Telephone: [phone] Telefax:

Contact: Date Prepared: Ronald K. Smith November 30, 2006

#### Device Information

| Trade name: | StaXx™ FX System |
|----------------------|-------------------------------------------------------------------------------------|
| Common name: | Internal Fracture Reduction System |
| Classification: | Class II per 21 CFR 888.3027; 21 CFR 888.4540 |
| Classification Name: | Polymethylmethacrylate (PMMA) bone cement;<br>Orthopedic manual surgical instrument |
| Product Code: | NDN; HXG |

### Device Description

The StaXx™ FX System is a vertebral fracture reduction device composed of a base wafer and stackable wafers fabricated from preformed Polyetheretherketone (PEEK-OPTIMA) with 6% Barium Sulfate (BaSO4). The wafers are designed to be inserted incrementally into the vertebral body to form a column that provides the desired fracture reduction. Twenty (20) wafers are provided per package. The wafers are provided in one width (8mm) with three lengths (20mm, 25mm, 30mm).

#### Intended Use

The StaXx™ FX System is indicated for use in the reduction of spinal fractures. It is intended to be used in combination with Stryker Spineplex™ Radiopaque Bone Cement.

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## Substantial equivalence1

The StaXx™ FX System described in this submission is substantially equivalent to the following device:

| Predicate Device | Manufacturer | 510(k) No. |
|------------------|------------------|------------|
| StaXx™ FX System | Spine Wave, Inc. | K053336 |

In addition, mechanical testing demonstrated that the StaXx™ FX System meets the performance requirements for its intended use. The minor differences between the StaXx™ FX System and the predicate device do not raise any new questions of safety or effectiveness. Thus, the StaXxTM FX System is substantially equivalent to its predicate device.

Use of the terms "substantially equivalent" and "substantial equivalence" in this application is intended only to denote a comparison of the subject device to predicate devices for the purpose of an FDA review of the safety and effectiveness of the subject device in accordance with 21 CFR 807. Statements comparing the subject device to predicate devices, including statements regarding "substantial equivalence", contained in any way to relate to patentability, patent infringement, or any analysis of the subject device under foreign or United States patent laws including 35 U.S.C. paragraph 100 et seg. or related judicial doctrines

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Spine Wave, Inc. % Mr. Ronald Smith Director, Quality and Regulatory Affairs Two Enterprise Drive, Suite 302 Shelton, Connecticut 06484

APR 1 3 2007

Re: K063606 Trade/Device Name: StaXx™ FX System Regulation Number: 21 CFR 888.3027 Regulation Name: Polymethylmethacrylate (PMMA) bone cement Regulatory Class: II Product Code: OBL Dated: February 9, 2007 Received: February 12, 2007

Dear Mr. Smith:

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. 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

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Page 2 - Mr. Ronald Smith

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 Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/cdrh/industry/support/index.html.

Sincerely yours,

Obara fuchs

Mark Melk erson Director Division of General, Restorative Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known):

Device Name: StaXx™ FX System

Indications for Use:

The StaXx™ FX System is indicated for use in the reduction of spinal fractures. It is intended to be used in combination with Stryker Spineplex™ Radiopaque Bone Cement.

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)

Barbara Buettner

Division of General, Restorative, and Neurological Devices

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510(k) Number