KIT MENDEC SPINE AND DELIVERY SYSTEM

K062452 · Tecres S.P.A. · NDN · Sep 21, 2006 · Orthopedic

Device Facts

• Record ID: K062452
• Device Name: KIT MENDEC SPINE AND DELIVERY SYSTEM
• Applicant: Tecres S.P.A.
• Product Code: NDN · Orthopedic
• Decision Date: Sep 21, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3027
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Kit Mendec Spine and delivery system is indicated for the treatment of pathological fractures of the vertebral body using a vertebroplasty procedure. Painful vertebral compression fractures may result from osteoporosis, benign (hemangioma), and malignant lesions (metastatic cancers, myeloma).

Device Story

Kit Mendec Spine and delivery system is a convenience kit for percutaneous vertebroplasty. It comprises an acrylic resin (bone cement) and a delivery system. The delivery system includes a syringe-like 'gun-system', an extension tube, and optionally a needle. The device is used by clinicians in a clinical setting to inject acrylic resin into the vertebral body to stabilize pathological fractures. The resin hardens to provide structural support, aiming to alleviate pain associated with vertebral compression fractures caused by osteoporosis or lesions. The kit consolidates necessary components for the procedure.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Kit contains acrylic resin and a mechanical delivery system (syringe-like gun, extension tube, needle). The resin is a methyl methacrylate-based bone cement. The device is a manual, non-powered mechanical system.

Indications for Use

Indicated for treatment of pathological vertebral body fractures via vertebroplasty. 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)

Submission Summary (Full Text)

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K062452

# Special 510(k) Kit Mendec Spine and delivery system

# ATTACHMENT 4

SEP 2 1 2006

## 510(k) Summary

## 510(k) Summary

| Official Correspondent: | Brauer Device Consultants LLC<br>1700 Research Boulevard, Suite 220<br>Rockville, Maryland 20850<br>Phone: [phone]<br>Fax: [phone]<br>Contact: Christine L. Brauer, Ph.D. |
|-------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer: | Tecres S.p.A.<br>Via Andrea Doria<br>37066 Sommacampagna<br>Verona - Italy<br>FDA Owner/Operator ID #: 9033624 |
| Date: | August 22, 2006 |

### Attachment 4

:

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# Special 510(k) Kit Mendec Spine and delivery system

## 510(k) Summary

| Trade/Proprietary Name: | Kit Mendec Spine and delivery system |
|------------------------------|----------------------------------------------------|
| Common Name: | Convenience Kit for percutaneous<br>vertebroplasty |
| Regulation Number: | 888.3027<br>888.4200 |
| Device Class: | II |
| Classification Panel: | Orthopedic |
| Classification Product Code: | NDN, LOD; KIH |

#### Intended Use:

The Kit Mendec Spine and delivery system is indicated for the treatment of pathological fractures of the vertebral body using a vertebroplasty procedures for the nodinall of painting may result from osteoporosis, benign lesions (hemangioma), and malignant lesions (may myeloma).

## Predicate Device Information

The predicate device is Mendec Spine (K042415).

### Device Description

Kit Mendec Spine and delivery system contains an acrylic resin for vertebroplasty and a delivery system. The acrylic resin consists of exportion of acryic Tosh 101 vercent. The delivery system consists of a syringe-like device with a "gun-system", an Extension tube, an Extension tube and may include, depending on the variant, a Needle.

## Substantial Equivalence

The components of the Kit Mendec Spine and delivery system are either exempt from premarket notification or have been found to be substantially equivalent through the premarket notification process for the use for which the sit is to be intended. Any difference that may exist do not significantly affect the substantial equivalence of the device.

Attachment 4

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Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, consisting of a staff with two snakes coiled around it. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" is arranged in a circular pattern around the caduceus.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 2 1 2006

Tecres S.p.A % Christine Brauer, Ph.D. Brauer Device Consultants 1700 Research Boulevard, Suite 220 Rockville, Maryland 20850

Re: K062452

Trade/Device Name: Kit Mendec Spine and Delivery System Regulation Number: 21 CFR 888.3027 Regulation Name: Methyl methacrylate for vertebroplasty Regulatory Class: Class II Product Code: NDN Dated: August 22, 2006 Received: August 22, 2006

Dear Dr. Brauer:

We have reviewed your Section 510(k) premarket notification of intent to market the device wt nave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the entributes of the enactment date of the Medical Device Amendments, or to conniner of the 114) 20, 1978, in accordance with the provisions of the Federal Food, Drug, de rices that have been require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The r ou may, merelore, mailes of the Act include requirements for annual registration, listing of general controls provision 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 If your device is blassified (600 a00 roy als. Existing major regulations affecting your device can inay of subject to suble additions, 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 I tease oc advised that I Dry Prosum that your device complies with other requirements of the Act that I Dri has made a sond regulations administered by other Federal agencies. You must of any I edetar studited and egginements, including, but not limited to: registration and listing (21 Comply with an the 11ct 31equirements, 01); good manufacturing practice requirements as set CFR in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic form in the quality bystems (Sections 531-542 of the Act); 21 CFR 1000-1050.

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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 240-276-0120. 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.

Sincerely yours,


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

Enclosure

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# Special 510(k) Kit Mendec Spine and delivery system

#### ATTACHMENT 2

#### Indications for Use

510(k) Number (if known):

Device Name: Kit Mendec Spine and delivery system

Indications for Use: The Kit Mendec Spine and delivery system is indicated for the treatment of pathological fractures of the vertebral body using a vertebroplasty procedure. Painful vertebral compression fractures may result from osteoporosis, benign (hemangioma), and malignant lesions (metastatic cancers, myeloma).

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)

K06 2452 Barbara Budup

(Division Sign-Off) Page *_ of _*

Division of General, Restorative, and Neurological Devices

510(k) Number (0624

p 1/1

Attachment 2

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