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 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.

AI/ML Overview

The provided text does not contain information about specific acceptance criteria with numerical performance targets for the device (Cemex Genta bone cement) or a detailed study proving its direct performance against such criteria. Instead, it focuses on demonstrating substantial equivalence to predicate devices through performance testing based on established standards.

Here's a breakdown of what can be extracted and what is not available in the given document:

1. Table of Acceptance Criteria and Reported Device Performance:

This information is not explicitly provided in the format requested. The document states that "Performance testing was conducted to verify that the modified bone cement performance continue to be adequate for in vivo applications and meet the requirements of ISO5833 and ASTM 451-99." However, it does not list specific numerical acceptance criteria (e.g., tensile strength > X MPa) or the precise performance values achieved by the Cemex Genta devices against those criteria. It only states that the properties were "evaluated and found to support the substantial equivalence of the device."

2. Sample Size Used for the Test Set and Data Provenance:

Sample Size: The document does not specify the sample size used for performance testing.
Data Provenance: The document does not specify the country of origin of the data or whether it was retrospective or prospective. It only mentions "in vivo applications," which implies testing relevant to biological systems.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

This information is not applicable as the document describes performance testing of a physical medical device (bone cement) against engineering standards (ISO and ASTM), not a diagnostic or AI-driven system requiring expert-established ground truth from a test set of images or clinical cases.

4. Adjudication Method for the Test Set:

This information is not applicable for the same reasons as point 3.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:

MRMC studies are relevant for diagnostic devices that involve human readers interpreting data, often with AI assistance. This document describes a bone cement, which is a therapeutic device. Therefore, an MRMC study was not done, and the concept of human readers improving with AI assistance is not relevant here.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done:

This concept is also not applicable to a bone cement. The "device" itself is the bone cement, not an algorithm. Its performance is evaluated through material and mechanical testing, not as a standalone algorithm.

7. The Type of Ground Truth Used:

The "ground truth" for evaluating the bone cement's performance was based on meeting the requirements of ISO 5833 and ASTM 451-99. These are international and American standards for "Implants for surgery – Acrylic resin cements" and "Standard Specification for Acrylic Bone Cement," respectively. These standards define the physical, chemical, and mechanical properties expected of such cements.

8. The Sample Size for the Training Set:

This information is not applicable. Bone cement is a physical product, not an AI model that requires a training set.

9. How the Ground Truth for the Training Set Was Established:

This information is not applicable for the same reasons as point 8.

Summary of available information regarding the study:

Study Type: Performance testing of chemical-physical and mechanical properties, gentamicin release, and stability data.
Purpose: To verify that the modified bone cement's performance remains adequate for in vivo applications and meets the requirements of ISO 5833 and ASTM 451-99.
Conclusion: The properties were "evaluated and found to support the substantial equivalence of the device."
Comparison: The modified Cemex Genta cements were found substantially equivalent to predicate devices (Cemex Genta and Cemex Genta System cleared via K033596; Cemex Genta System Fast cleared via K043403).

Summary

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NOV 2 4 2009

510 (k) Summary

510(k) Number:	K092773
Official correspondent:	Christine L. Brauer, Ph.D.US AGENT
Manufacturer/Submitter:	TECRES S.P.A.Via Andrea Doria37066 SOMMACAMPAGNAVERONA - ITALY
	FDA owner/operator ID #: 9033624
Date:	NOVEMBER 23, 2009
Trade/Proprietary model names:	CEMEX GENTACEMEX GENTA SYSTEMCEMEX 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:

INTENDED USE:

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 (800) 638-2041 or (301) 796-7100 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)

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

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510(k) Number K092773

Regulation Number and Section

§ 888.3027 Polymethylmethacrylate (PMMA) bone cement.

(a)
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.(b)
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.”