MENDEC SPINE

K042415 · Tecres S.P.A. · NDN · Jun 9, 2005 · Orthopedic

Device Facts

• Record ID: K042415
• Device Name: MENDEC SPINE
• Applicant: Tecres S.P.A.
• Product Code: NDN · Orthopedic
• Decision Date: Jun 9, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3027
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

Mendec Spine is a two-component acrylic bone cement (PMMA-based) used in vertebroplasty or kyphoplasty procedures. The system consists of a powder component (PMMA-styrene copolymer, barium sulphate, benzoyl peroxide) and a liquid component (methylmethacrylate monomer, hydroquinone, N,N-dimethyl-p-toluidine). Components are mixed by the clinician prior to use to initiate polymerization. The resulting cement is injected into the vertebral body to stabilize pathological fractures. The device provides structural support to the fractured vertebra, potentially reducing pain and restoring vertebral integrity. It is intended for use by physicians in a clinical or surgical setting.

Clinical Evidence

No clinical data provided. Substantial equivalence was established through bench testing, including mechanical performance testing per ISO 5833:2002 and biocompatibility testing per ISO 10993 and ASTM F 451-99.

Technological Characteristics

Two-component PMMA-based acrylic bone cement. Powder: PMMA-styrene copolymer, barium sulphate (radiopacifier), benzoyl peroxide (initiator). Liquid: Methylmethacrylate monomer, hydroquinone (stabilizer), N,N-dimethyl-p-toluidine (promoter). Complies with ASTM F 451-99 and ISO 5833:2002. Sterilization: Solid components via ethylene oxide (EO) gas; liquid components via filtration. Single-use.

Indications for Use

Indicated for patients with painful vertebral compression fractures resulting from osteoporosis, benign lesions (hemangioma), or malignant lesions (metastatic cancers, myeloma) requiring vertebroplasty or kyphoplasty.

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

• Kyphx HV-R Bone Cement (K033801)
• Kyphx HV-R Bone Cement (K041584)
• Stryker Spineplex Radiopaque Bone Cement (K032945)

Submission Summary (Full Text)

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# K042415

JUN 9 – 2005

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. : Mendec Spine

Company confidential

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## Traditional 510(k)

# Summary of Safety and Effectiveness

| Official Correspondent: | Christine Brauer, Ph.D.<br>Regulatory Affairs Consultant<br>One Democracy Plaza<br>6701 Democracy Boulevard, Suite 700<br>Bethesda, MD 20817<br>tel: [phone]<br>fax: [phone]<br>E-MAIL: [e-mail] | | |
|-------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|
| Trade Name: | Mendec Spine | | |
| Common Name: | Bone Cement | | |
| Classification Name: | Bone Cement, 888.3027 | | |
| Device code: | NDN, LOD | | |
| Manufacturer/Submitter: | TECRES S.p.A FDA Owner number: 9033624<br>Via Andrea Doria 10,<br>37066 Sommacampagna, Verona, Italia<br>Phone: [phone]<br>Fax: [phone] | | |
| Contact person: | Massimo Grazioli, General Manager | | |
| Predicate device: | K033801: Kyphx HV-R Bone Cement (Kyphon Inc.).<br>K041584: Kyphx HV-R Bone Cement (Kyphon Inc.).<br>K032945: Stryker Spineplex Radiopaque Bone Cement (Stryker) | | |
| Indications for use: | Mendec Spine is indicated for the treatment of pathological<br>fractures of the vertebral body using a vertebroplasty or<br>kyphoplasty procedure. Painful vertebral compression fractures<br>may result from osteoporosis, bening lesions (hemangioma), and<br>malignant lesions (metastatic cancers, mylema) | | |
| Device Description: | Like the predicate devices. Mendec Spine acrylic resin is provided<br>as a two-component system. The powder component consists of a<br>PMMA-styrene copolymer with barium sulphate as a radiopacifier<br>and benzoyl peroxide as an initiator. The liquid component consists<br>of methylmethacrylate monomer, with the addition of<br>hydroquinone as a stabiliser and N.N-dimethyl-p-toluidine as<br>promoter. The powder and liquid components are mixed prior to<br>Section 4<br>Page 1/2 | | |

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K042415

#### Company confidential

#### Traditional 510(k)

Mendec Spine

## Summary of Safety and Effectiveness

Table 4-1 compares the chemical composition of Mendec use. Spine to the predicate device.

#### Table 4-1 Chemical composition of Mendec Spine and Kyphx HV-R

| Chemical composition | KyphX HV-R<br>#K033801<br>#K041584 | Spineplex<br>#K032945 | Mendec Spine |
|------------------------------|------------------------------------|-----------------------|--------------|
| Powder | 20 g | 20 g | 20 g |
| Polymethymethacrylate | $68,0% w/w$ | $68,50% w/w$ | $67,50% w/w$ |
| Barium sulphate | $30,0% w/w$ | $30,0% w/w$ | $30,0% w/w$ |
| Benzoyl peroxide | $2,0% w/w$ | $1,5% w/w$ | $2.5% w/w$ |
| Liquid | 9 g | 9.96 ml (9.05 g) | 9.4 g |
| Methylmethacrylate (monomer) | $99,1% w/w$ | $97,4% w/w$ | $99.1% w/w$ |
| N.N-dimethyl-p-toluidine | $0,90% w/w$ | $2,60% w/w$ | $0,90% w/w$ |
| Hydroquinone | 75 ppm | 75 ppm | 75 ppm |

Mechanical tests: Mendec Spine acrylic resin was tested in direct comparison to the predicate device and verified substantially equivalent, as defined by ISO 5833:2002, "Implants for Sugery - Acrylic resin cements" Non-clinical test results: Performance testing demonstrated that Mendec Spine is substantially equivalent to the Kyphx HV-R with regard to functional characteristics Clinical results; Clinical information demonstrates that the intended use is substantially equivalent to the predicate indication for the treatment of pathological vertebral body fractures and does not adversely impact safety and effectiveness. Biocompatibility:

The materials used in Mendee Spine complies with ASTM F 451-99 point 10 and ISO 10993

Sterilization: The Mendee Spine acrylic resin is sterile and non-pyrogenic. The solid components are sterilised with ethylene oxide (EO) gas to a Sterility Assurance Level (SAL) of 10th. The liquid components are sterilized with filtration methods to a SAL of 102. The outer packaging containing the liquid component is sterifised with ethylene oxide (EO) gas. The acrylic resin is intended for single use only.

> Section 4 Page 2/3

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K042415
Mendec Spine

Company confidential

LONGLAND REPRENTWERSON ..... ... ... ... ... .. .. .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

## Traditional 510(k)

INSUL INCLUSION IN MARKET PURGE

BARRE BL. GELLERS AND AND AND BELLER

www.wanawar.ua

consistences ... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

## Summary of Safety and Effectiveness

Substantial Equivalence: The chemical constituents in Mendec Spine acrylic resin are substantially equivalent to those in the predicates Kyphx HR-V (#K033801; #K041584) and in the predicate Spineplex (#K032945).

> Section 4 Page 3/3

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 9 - 2005

Tecres Spa C/o Christine L. Brauer, Ph.D Regulatory Affairs Consultant Brauer Device Consultants, LLC One Democracy Plaza 6701 Democracy Boulevard, Suite 700 Bethesda, Maryland 20817

Re: K042415

Trade/Device Name: Mendec Spine Regulation Number: 21 CFR 888.3027 Regulation Name: Polymethylmethacrylate (PMMA) bone cement Regulatory Class: II Product Code: NDN Dated: May 18, 2005 Received: May 18, 2005

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 sct

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.

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Page 2 -Christine L. 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,

H.A. Chuds

2. Miriam Provost, Ph.D.

Miriam Prov st. Ph.D Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known): K042415

Device Name: Mendec Spine

Indications For Use:

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

Prescription Use ﺮ ﺍﻟﻤﺮﺍﺟﻊ (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)

Concurrence of CDRH, Office of Device Evaluation (ODE)

H. Curtis

Page 1 of ____________________________________________________________________________________________________________________________________________________________________

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

510(k) Number