VSPSPN

K063438 · Tecres S.P.A. · NDN · Jan 17, 2007 · Orthopedic

Device Facts

• Record ID: K063438
• Device Name: VSPSPN
• Applicant: Tecres S.P.A.
• Product Code: NDN · Orthopedic
• Decision Date: Jan 17, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3027
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Vspspn is indicated for the treatment of pathological fractures of the vertebral body using a vertebroplasty or kyphoplasty procedure. Painful vertebral compression fractures may result from osteoporosis, benign lesions (hemangioma), and malignant lesions (metastatic cancers, myeloma).

Device Story

Vspspn is a two-part (powder and liquid) radiopaque, polymethyl methacrylate (PMMA) acrylic resin bone cement. The components are mixed at the point of use by a clinician to form the resin. The device is used during vertebroplasty or kyphoplasty procedures to treat pathological vertebral body fractures. The resin is injected into the vertebral body to provide structural support and stabilization. The device is supplied sterile for single use.

Clinical Evidence

No clinical data provided; substantial equivalence is based on bench testing and comparison of technological characteristics to the predicate device.

Technological Characteristics

Two-part (powder and liquid) polymethyl methacrylate (PMMA) acrylic resin. Radiopaque. Supplied sterile for single use. Mechanical and performance characteristics are equivalent to predicate bone cements.

Indications for Use

Indicated for treatment of pathological vertebral body fractures via vertebroplasty or kyphoplasty. Patient population includes individuals with painful vertebral compression fractures due to osteoporosis, benign lesions (hemangioma), or malignant lesions (metastatic cancers, myeloma).

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

• Mendec Spine (K042415)
• Visioplast (K042414)

Submission Summary (Full Text)

{0}------------------------------------------------

K063438

Image /page/0/Picture/1 description: The image shows the logo for Tecres Medical. The logo features the word "TECRES" in large, bold, sans-serif font, with the word "MEDICAL" in a smaller font underneath. Below the word "MEDICAL" is the phrase "Advancing High Technology". To the right of the text is a stylized cube design.

Vspspn Traditional 510(k) Section 4

JAN 1 7 2007

## Summary of Safety and Effectiveness

| Applicant/consultant: | Brauer Device Consultants LLC |
|-----------------------|------------------------------------|
| | 1700 Research Blvd., Suite 220 |
| | Rockville, Maryland 20850 |
| | Phone: [phone] |
| | Fax: [phone] |
| | Contact: Christine L. Brauer, Ph.D |

| Manufacturer/Submitter: | Tecres S.p.A. |
|-------------------------|--------------------------------------------|
| | Via Andrea Doria, 6<br>37066 Sommacampagna |
| | Verona - Italy |
| | FDA owner/operator ID #: 9033624 |

Date:

November 14, 2006

| Trade/Proprietary name: | Vspspsn |
|------------------------------|---------------|
| Common name: | Acrylic Resin |
| Regulation number: | 888.3027 |
| Device class: | II |
| Classification panel: | Orthopedic |
| Classification Product Code: | NDN, LOD |

### Intended Use:

Vspspn is indicated for the treatment of pathological fractures of the vertebral body.

### Predicate Device Information

The predicate device is Mendec Spine (K042415) and, for the packaging, Visioplast (#K042414).

### Device Description

Vspspn is a two-part (powder and liquid) radiopaque, polymethyl methacrylate acrylic resin. The powder and liquid components are mixed together at the point of use to form the resin. The product is supplied sterile, for single use.

| 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11<br>итинанарамының айтыншатын аттыратының айынша тұрғынының ұйылы 1 4 4 7 1 7 2 | | 1 11 6 |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--------|
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--------|

{1}------------------------------------------------

Image /page/1/Picture/0 description: The image shows the logo for TECRES Medical. The logo features the word "TECRES" in large, bold, black letters, with the word "MEDICAL" in smaller letters underneath. Below the word "MEDICAL" is the phrase "Advancing High Technology". To the right of the text is a geometric design that resembles a cube.

Vspspn

## Traditional 510(k) Section 4

# Summary of Safety and Effectiveness

## Substantial Equivalence

Vspspn is substantially equivalent to the predicate Mendec Spine (K042415) since they have the same design, incorporate the same materials, have the same performance and mechanical characteristics, have the same shelf life and equivalent packaging, and are sterilized by the same method.

{2}------------------------------------------------

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Tecres SPA % Christine Brauer, Ph.D. Brauer Device Consultants, LLC 1700 Research Boulevard Rockville, Maryland 20850

JAN 17 2007

Re: K063438

Trade/Device Name: VSPSPN Regulation Number: 21 CFR 888.3027 Regulation Name: Cement, bone, vertobroplasty Regulatory Class: Class II Product Code: NDN Dated: November 14, 2006 Received: November 15, 2006

Dear Dr. Brauer:

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,

{3}------------------------------------------------

Page 2 - Christine Brauer, Ph.D.

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 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.

Barbara Bruchus
for

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

Enclosure

{4}------------------------------------------------

## Indications for Use

£063438 510(k) Number (if known):

Device Name: Vspspn

Indications For Use:

Vspspn is indicated for the treatment of pathological fractures of the vertebral body using a vertebroplasty or kyphoplasty procedure. Painful vertebral compression fractures may result from osteoporosis, benign lesions (hemangioma), and malignant lesions (metastatic cancers, myeloma).

Prescription Use X (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 IF NEEDED)

AH Office of Device Evaluation (ODE)

(Division Sign Division of General, Restorative, and Neurological Devices

Page 1 of 1

510(k) Number K063438