OPACITY + BONE CEMENT

K080873 · Teknimed, S.A. · NDN · Aug 28, 2008 · Orthopedic

Device Facts

• Record ID: K080873
• Device Name: OPACITY + BONE CEMENT
• Applicant: Teknimed, S.A.
• Product Code: NDN · Orthopedic
• Decision Date: Aug 28, 2008
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3027
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Opacity + 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

Opacity + Bone Cement is a self-hardening, ready-to-use PMMA-based bone cement; designed for percutaneous vertebroplasty and kyphoplasty procedures. Device consists of two sterile components: powder (polymethylmethacrylate and benzoyl peroxide initiator) and liquid monomer (methyl methacrylate). Components are mixed to initiate polymerization, creating a radiopaque cement for vertebral body consolidation and pain relief. Used in clinical settings by physicians; injected into the vertebral body to stabilize fractures. Provides structural support for pathological fractures caused by osteoporosis or malignancy. Benefits include rapid pain relief and vertebral body consolidation.

Clinical Evidence

Bench testing only. Properties of Opacity + Bone Cement were evaluated for stability and compliance with ISO 5833 (implants for surgery - acrylic resin cements). Results indicate performance is similar to predicate devices.

Technological Characteristics

PMMA-based bone cement; two-component system (powder/liquid). Powder contains PMMA and benzoyl peroxide; liquid contains methyl methacrylate. Includes radiopaque agent. Complies with ISO 5833 standards. Manual mixing/application. Non-electronic, non-software device.

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.”

Predicate Devices

• Spine-Fix Biomimetic Cement (K043593)

Submission Summary (Full Text)

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

510(k) Summary Opacity + Cement K080873 Teknimed SA Submitter l 1 rue Apollo AUG 2 8 2008 Z.I. Montredon 31240 L'Union France J.D. Webb Contact person 1001 Oakwood Blvd Round Rock, TX 78681 512-388-0199 Trade Name Opacity + Bone Cement Polymethylmethacrylate (PMMA) bone cement Common name Classification name Cement, Bone, Vertebroplasty Class II per 21 CFR section 888.3027 Product Code NDN Spine-Fix Biomimetic Cement, K043593 Equivalent Device Opacity + is a self-hardening and ready to use bone cement with a high amount of Device Description radiopaque agent for percutaneous vertebroplasty. It allows an excellent consolidation of the vertebral body and an effective and rapid pain relief. This type of cement 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 box. 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. The Opacity + Bone Cement is used for the fixation of pathological fractures of the Intended Use 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). Test data indicate that the final properties of Opacity + Bone Cement are stable and Nonclinical in compliance with the standard reference for bone cement: ISO 5833 "implants for surgery - acrylic resin cements" and are similar to predicate devices The modified Opacity + cement is substantially equivalent to commercially Conclusion marketed device, Spine-Fix Biomimetic Cement, K043593.

> 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.

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

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 2 8 2008

Teknimed SA % The Orthomedix Group, Inc. J.D Webb Authorized Contact Person 1001 Oakwood Boulevard Round Rock, Texas 78681

Re: K080873

Trade/Device Name: Opacity + Bone Cement Regulation Number: 21 CFR 888.3027 Regulation Name: Polymethylmethacrylate (PMMA) bone cement. Regulatory Class: II Product Code: NDN Dated: July 25, 2008 Received: July 30, 2008

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 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

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

Page 2 - Mr. J.D. Webb

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. product raunil 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. 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. Millman

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

Enclosure

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

## Indications for Use

K080873 510(k) Number (if known):

Device Name: Opacity + Bone Cement

## Indications For Use:

The Opacity + 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 (hemangiom), or 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)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark A. Millers

ion=( )f Division of General, Restorative, and Neurological Devices

K080873 510(k) Number_

Page 1 of 1

.

.

. . . .