VERTECEM

K090435 · Teknimed, S.A. · NDN · Dec 21, 2009 · Orthopedic

Device Facts

• Record ID: K090435
• Device Name: VERTECEM
• Applicant: Teknimed, S.A.
• Product Code: NDN · Orthopedic
• Decision Date: Dec 21, 2009
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3027
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Vertecem Bone Cement is used for the fixation of pathological fractures of the vertebral body using vertebroplasty or kyphoplasty procedures. Painful vertebral compression fractures of the vertebral body may result from osteoporosis, benign lesions (hemangioma), or malignant lesions (metastatic cancers, myeloma).

Device Story

Vertecem Bone Cement is a self-hardening, ready-to-use PMMA bone cement designed for percutaneous vertebroplasty and kyphoplasty. The device consists of two sterile components: a powder (PMMA and benzoyl peroxide) and a liquid monomer (methyl methacrylate). These components are mixed to initiate polymerization, creating a radiopaque cement used to consolidate the vertebral body. The device is intended for use by clinicians in a surgical or clinical setting to stabilize fractures and provide pain relief for patients with vertebral compression fractures. The high radiopacity allows for visualization during the procedure, assisting the physician in accurate placement and monitoring of the cement injection.

Clinical Evidence

Bench testing only. Data indicates final properties of the bone cement are stable and in compliance with standard references for bone and resin cements, showing similarity to predicate devices.

Technological Characteristics

Two-component PMMA bone cement. Powder component: PMMA and benzoyl peroxide. Liquid component: methyl methacrylate. Includes radiopaque agent. Self-hardening via polymerization. Supplied in sterile double packaging (blister pack and peelable pouch).

Indications for Use

Indicated for fixation of pathological vertebral body fractures via vertebroplasty or kyphoplasty. Patient population includes individuals with painful vertebral compression fractures resulting from 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.”

Submission Summary (Full Text)

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XO90435

# 510(k) Summary for the Vertecem Bone Cement

DEC 2 1 2009

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In accordance with 21 CFR 807.92 of the Federal Code of Regulations the following 510(k) summary is submitted for the Vertecem Bone Cement

Date Prepared: February 16, 2009

1. Submitter: Teknimed SA 11 rue Apollo Z.I. Montredon 31240 L'Union France

Contact Person: J.D. Webb The OrthoMedix Group, Inc. 1001 Oakwood Blvd Round Rock, TX 78681 Telephone: [phone]

2. Trade name: Vertecem Bone Cement Common Name: Polymethylmethacrylate (PMMA) bone cement Classification Name: Cement, Bone, Vertebroplasty Class II per 21 CFR section 888.3027 NDN

3. Predicate or legally marketed devices which are substantially equivalent: Vertecem Bone Cement is substantially equivalent to similar previously cleared bone cements.

## 4. Description of the device:

Vertecem is a self-hardening and ready to use bone cement with a high amount of radiopaque agent for perculaneous vertebroplasty. It allows an excellent consolidation of the vertebral body and an effective and rapid privation in this type of coment is made of two sterile components: the polymer in powder and the liquid monomer. These two components are in a double sterile packaging. Each unit contains a sterile ampoule of liquid within a blister pack and a powder within a double peelable pouch, the whole being packaged in a hox.

### Materials:

The liquid component is mainly composed of methyl methacrylate. The major powder component is polymethylmethacrylate (PMMA). Benzoyl peroxide which initiates the polymerization is included in the polymer powder.

## 5. Intended Use:

The Vertecem Bone Cement is used for the fixation of pathological fractures of the vertebral body using vertebroplasty or kyphoplasty procedures. Painful vertebral compression fractures of the vertebral body may result from osteoporosis, benign lesions (benner of the (metastatic cancers, myeloma).

#### Comparison of the technological characteristics of the device to predicate and legally 6. marketed devices:

The modified Vertecem Bone Cement is substantially equivalent to commercially marketed predicate device. The modifications do not change the intended use or fundamental scientific technology of the device and do not raise any new issues of safety or effectiveness.

# 7. Summary of Nonclincal Tests

Test data indicate that the final properties of Vertecem Bone Cement are stable and in compliance with the standard reference for bone cement alle "centerit alle" and "in resin cements" and are similar to predicate devices.

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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services-USA. The seal features the department's name in a circular arrangement around a stylized caduceus symbol. The caduceus is depicted as a modern interpretation of the traditional medical symbol, with a focus on abstract, flowing lines.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

# DEC 2 1 2009

Teknimed, S.A. % The OrthoMedix Group, Inc. Mr. J.D. Webb 1001 Oakwood Boulevard Round Rock, Texas 78681

Re: K090435

Trade/Device Name: Vertecem Bone Cement Regulation Number: 21 CFR 888.3027 Regulation Name: Polymethylmethacrylate (PMMA) bone cement Regulatory Class: Class II Product Code: NDN Dated: November 23, 2009 Received: December 2, 2009

Dear Mr. Webb:

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 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); medical device reporting (reporting of medical

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Page 2 - Mr. J.D. Webb

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/cdrh/mdr/ 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/cdrh/industry/support/index.html.

Sincerely yours,

Mark N. Melkerson
Director

Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known):

Device Name:__________Vertecem Bone Cement

Indications For Use:

.

The Vertecem Bone Cement is used for the fixation of pathological fractures of the vertebral body using vertebroplasty or kyphoplasty or trialules of the compression fractures of the vertebral body may result from osteoporosis, benign lesions (hemangioma), or malignant lesions (metastatic cancers, mycloma),

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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

KIMBERLY A. TAYLOR FOR M. MELKERSON

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

510(k) Number K090435