CEMEX GENTA, GENTA SYSTEM AND GENTA SYSTEM FAST

K092773 · Tecres S.P.A. · LOD · Nov 24, 2009 · Orthopedic

Device Facts

• Record ID: K092773
• Device Name: CEMEX GENTA, GENTA SYSTEM AND GENTA SYSTEM FAST
• Applicant: Tecres S.P.A.
• Product Code: LOD · Orthopedic
• Decision Date: Nov 24, 2009
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3027
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Cemex Genta/Cemex Genta System/Cemex Genta System Fast bone cement is indicated for the fixation of prostheses to living bone in the second stage of a two-stage revision for total joint arthroplasty after the initial infection has been cleared.

Device Story

Cemex Genta, Cemex Genta System, and Cemex Genta System Fast are PMMA-based bone cements containing gentamicin sulphate. The device consists of a liquid component (methylmethacrylate, N-N dimethyl p-toluidine, hydroquinone) and a dry powder component (polymethylmethacrylate, barium sulphate, benzoyl peroxide, gentamicin sulphate). The components are mixed by a clinician in an orthopedic surgical setting to create a cement for the fixation of prostheses to living bone. The device functions as a structural adhesive and local delivery vehicle for gentamicin. It is used by orthopedic surgeons during revision arthroplasty procedures to secure implants after infection resolution.

Clinical Evidence

Bench testing only. Performance testing verified compliance with ISO 5833 and ASTM 451-99 standards. Chemical-physical and mechanical properties, gentamicin release, and stability data were evaluated to support substantial equivalence.

Technological Characteristics

PMMA bone cement. Liquid: methylmethacrylate, N-N dimethyl p-toluidine, hydroquinone. Powder: polymethylmethacrylate, barium sulphate, benzoyl peroxide, gentamicin sulphate. Complies with ISO 5833 and ASTM 451-99. Manual mixing/application.

Indications for Use

Indicated for patients undergoing the second stage of a two-stage revision for total joint arthroplasty following the clearance of an initial infection.

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

• Cemex Genta and Cemex Genta System (K033596)
• Cemex Genta System Fast (K043403)

Submission Summary (Full Text)

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NOV 2 4 2009

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# 510 (k) Summary

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| 510(k) Number: | K092773 |
|--------------------------------|----------------------------------------------------------------------------|
| Official correspondent: | Christine L. Brauer, Ph.D.<br>US AGENT |
| Manufacturer/Submitter: | TECRES S.P.A.<br>Via Andrea Doria<br>37066 SOMMACAMPAGNA<br>VERONA - ITALY |
| | FDA owner/operator ID #: 9033624 |
| Date: | NOVEMBER 23, 2009 |
| Trade/Proprietary model names: | CEMEX GENTA<br>CEMEX GENTA SYSTEM<br>CEMEX SYSTEM GENTA FAST |
| Common name: | BONE CEMENT |
| Device classification name: | POLYMETHYLMETHACRYLATE (PMMA) BONE CEMENT |
| Regulation number: | 888.3027 |
| Device class: | II |
| Classification panel: | ORTHOPAEDIC |
| Classification product code: | LOD |

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#### DEVICE DESCRIPTION:

All Cemex Genta bone cements contain the same individual chemical constituents. The liquid components contain methylmethacrylate, N-N dimethy] p-toluidine and hydroquinone. The dry powder component contains polymethylmethacrylate, barium sulphate, benzoyl peroxide and gentamicin sulphate.

#### INTENDED USE:

Cemex Genta/Cemex Genta System/Cemex Genta System Fast bone cement is indicated for the fixation of prostheses to living bone in the second stage of a two-stage revision for total joint arthroplasty after the initial infection has been cleared.

### PREDICATE DEVICES TO WHICH SUBSTANTIAL EQUIVALENCE IS CLAIMED:

The modified Cemex Genta, Centa System and Cemex Genta System Fast bone cements are substantially equivalent to the following predicate devices:

- · Cemex Genta and Cemex Genta System cleared via K033596
- · Cemex Genta System Fast cleared via K043403

#### SUBSTANTIAL EQUIVALENCE:

Performance testing was conducted to verify that the modified bone cement performance continue to be adequate for in viyo applications and meet the requirements of ISO5833 and ASTM 451-99.

Chemical-physical and mechanical properties, gentamicin release and stability data were evaluated and found to support the substantial equivalence of the device.

Based on the same fundamental scientific technology and on results of the verification activities, it is concluded that the Cemex Genta bone cements manufactured with gentamicin sulphate are substantially equivalent to the legally marketed ones.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features a circular border with the text "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 and provide essential human services.

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

Tecres S.p.A. % Brauer Device Consultants, LLC Christine L. Brauer, Ph.D. Regulatory Affairs Consultant 7 Trailhouse Court Rockville, Maryland 20850

NOV 2 4 2009

Re: K092773

Trade/Device Name: Cemex Genta/Cemex Genta System/Cemex Genta System Fast Regulation Number: 21 CFR 888.3027 Regulation Name: Polymethylmethacrylate (PMMA) bone cement Regulatory Class: Class II Product Code: LOD, MBB Dated: October 27, 2009 Received: October 28, 2009

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 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

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Page 2 - Christine L. Brauer, Ph.D.

CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical 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 100-100.

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/ucm11 S800.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 notfication" (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/cdrl/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 tolloffree number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Murle A. Millerson

Mark N. Melkerson 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 Form

510(k) Number (if known): K092773

:

Device Name: Cemex Genta/Cemex Genta System/Cemex Genta System Fast

Indications for Use: Cemex Genta/Cemex Genta System/Cemex Genta System Fast bone cement is indicated for the fixation of prostheses to living bone in the second stage of a two-stage revision for total joint arthroplasty after the initial infection has been cleared.

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)

Khumunl/l/l/l/l/l/l/l/l/l/l/l/l/l/l/l/l/l/l/l/l/l/l/l/l/l/l/l/l/l/l/l/l/l/l/l/l/l/l/l/l/l/l/l/l/l/l/l/l/l/l/l/l/l/l/l/l/l/l/l/l/l/l/l/l/l/l/l/l/l/l/l/l/l/l/l/l/l/l/l/l/l/l/l/l/l/l/l/l/l/l/l/l/l/l/l/l/l/l/l/l/l/l/l/l/l/l/l/l/l/l/l/l/l/l/l/l/l/l/l/l/l/l/l/l/l/l/l/l/l/l/l/l/l/l/l/l/l/l/l/l/l/l/l/l/l/l/l/l/l/l/l/l/l/l/l/l/l/l/l/l/l/l/l/l/l/l/l/l/l/l/l/l/l/l/l/l/l/l/l/l/l/l/l/l/l/l/l/l/l/l/l/l/l/l/l/l/l/l/l/l/l/l/l/l/l/l/l/l/l/l/l/l/l/l/l/l/l/l/l/l/l/l/l/l/l/l/l/l/l/l/l/l/l/l/l/l/l/l/l/l/l/l/FOR M. MELKERSON

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

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510(k) Number K092773