Cemex Genta / Cemex Genta System 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

Cemex Genta System and Cemex Genta bone cement are substantially equivalent to the predicate Cemex System bone cement (#K000943). The physical and chemical characteristics of the individual components are identical to those of Cemex System, apart from the additional presence of gentamicin sulphate in the powder. The liquid component contains methylmethacrylate, N-N dimethyl p-toluidine, and hydroquinone. The dry powder component contains polymethylinethacrylate, barium subhate, benzoyl peroxide and gentamicin sulphate.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Tecres Cemex® Genta bone cement.

This document describes a 510(k) premarket notification for a medical device. 510(k) submissions typically demonstrate substantial equivalence to a legally marketed predicate device, rather than proving performance against novel acceptance criteria through extensive clinical studies. Therefore, many of the requested elements for a typical "acceptance criteria and study" may not be fully applicable or explicitly detailed in this type of submission.

Based on the provided text, the primary "acceptance criteria" is demonstrating substantial equivalence, and the "study" is a comparison to a predicate device and performance testing against recognized standards.

Acceptance Criteria and Study for Tecres Cemex® Genta Bone Cement

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Demonstrates Substantial Equivalence and Performance)	Reported Device Performance
Substantial Equivalence to Predicate Device	Cemex Genta System and Cemex Genta bone cement are substantially equivalent to the predicate Cemex System bone cement (#K000943). The physical and chemical characteristics of the individual components are identical to those of Cemex System, apart from the additional presence of gentamicin sulphate in the powder. (This difference is addressed by demonstrating that the addition of gentamicin does not negatively impact performance compared to the predicate, and that the physical and chemical characteristics are otherwise identical).
Compliance with ISO 5833 Standard	Performance testing shows that the proposed devices meet the requirements of ISO 5833.
Compliance with ASTM 451-99 Standard	Performance testing shows that the proposed devices meet the requirements of ASTM 451-99.
Sterility Assurance Level (SAL) for Powder Component	Powdered component is sterilized by ethylene oxide (EO) to a SAL of 10⁻⁶.
Sterility Assurance Level (SAL) for Liquid Component	Liquid component is sterilized by a membrane filtration technique to a SAL of 10⁻³.
Packaging Equivalence	Packaging design is identical to predicate devices (#K000943 for Cemex System, #K021715 for Cemex RX, ISOPLASTIC and XL) except for the addition of an aluminum bag that serves as a moisture barrier.
Intended Use	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. (This is an indication, not a performance criterion in the same way, but demonstrating that the device is suitable for this specific use is part of the substantial equivalence argument).

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

Sample Size: The document does not specify a "test set" sample size in terms of clinical cases or patient data. The evaluation is primarily based on laboratory performance testing (to ISO and ASTM standards) and a comparison of material characteristics to a predicate device. For material testing, sample sizes would typically be governed by the respective standards, but are not explicitly stated here.
Data Provenance: The data provenance is from laboratory testing (conducted by the manufacturer or a contracted lab) and comparison against the specifications of the predicate device (Tecres S.p.A, Cemex System #K000943). There is no mention of clinical data, human subjects, or country of origin for such data. This is characteristic of a 510(k) submission for this type of device, which often relies on non-clinical performance data and comparison to established devices.

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

Not applicable in this context. Ground truth in the sense of expert clinical consensus on patient outcomes or diagnoses is not established from this document. The "ground truth" for the performance testing is adherence to the specified ISO and ASTM standards, which are internationally recognized and developed via expert consensus within their respective fields (e.g., materials science, biomechanics). The "ground truth" for substantial equivalence is the prior FDA clearance of the predicate device.

4. Adjudication Method for the Test Set

Not applicable in this context. Adjudication methods like "2+1" are typical for clinical studies involving interpretation of medical images or patient outcomes by multiple readers. This submission relies on objective laboratory test results and regulatory comparison, not subjective expert adjudication of a test set.

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

No. An MRMC comparative effectiveness study was not done. This type of study assesses the relative effectiveness of different diagnostic or interventional methods, often involving human readers' performance with and without AI assistance. This submission does not involve AI, diagnostic imaging, or the comparison of human reader performance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

No. This is not an AI/algorithm-based device. It is bone cement. Therefore, "standalone" algorithm performance is not applicable.

7. The Type of Ground Truth Used

The "ground truth" used for this submission is based on:
- Regulatory Standard Compliance: Adherence to established international (ISO 5833) and national (ASTM 451-99) standards for bone cement performance. These standards define the expected physical and mechanical properties.
- Predicate Device Characteristics: The known physical, chemical, and performance characteristics of the legally marketed predicate device (Cemex System #K000943).
- Sterility Assurance Levels: Defined and validated Sterility Assurance Levels for the manufacturing process.

8. The Sample Size for the Training Set

Not applicable. This submission focuses on a medical device (bone cement), not a machine learning model or AI algorithm that requires a training set.

9. How the Ground Truth for the Training Set was Established

Not applicable. As there is no training set for an AI/ML model, this question does not apply.

Summary

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K03596 Page 143 P.2

Image /page/0/Picture/1 description: The image shows the date and time "May 05 04 12:18p" at the top. Below the date and time is the word "Exactech" in a stylized font. The word is in white text on a black background.

MAY 1 0 2004

2320 NW 6614 COURI GAINESVILLE, G. 3255.

352-371-1140 FAX 352-378-26 17

Tecres Cemex® Genta bone cement Traditional 510(k)#K033596

Summary of Safety and Effectiveness

Applicant/Consultant:	Exactech® Inc.2320 N.W. 66th CourtGainesville, Florida 32653
	Phone:Fax:	(352) - 377 - 1140(352) - 378 - 2617
	FDA Establishment # 1038671
Manufacturer:	TECRES S.p.AVia Andrea Doria 10,37066 Sommacampagna, Verona, Italia
	FDA Owner number: # 9033624
Contact:	Gary J. Miller, PH.D.Exec. Vice President of Research & DevelopmentExactech, Inc.
Date:	May 5, 2004

rev. 05 05 04

Section 4 Page 1 of 3

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K033596 page 2注8

Tecres Cemex® Genta bone cement Traditional 510(k)#K033596

Summary of Safety and Effectiveness

Trade Names:	Cemex Genta Bone CementCemex Genta System Bone Cement
Common Name:	Bone Cement
Classification Name:	Polymethylmethacrylate (PMMA)Bone Cement

Levally Marketed Device for Substantial Equivalence Comparison:

Model	Manufacturer	510(k) Number
Cemex System	Tecres, S.p.A.	#K000943

INDICATIONS FOR USE

CONTRAINDICATIONS

Cemex Genta / Cemex Genta System bone cement is contraindicated in primary orthopaedic musculoskeletal surgical procedures.

Cemex Genta / Cemex Genta System bone cement is contraindicated in patients who are allergic or sensitive to any of its components, including Gentamicin Sulphate.

If the patient has a history of hypersensitivity or serious toxic reactions to aminoglycosides, the use of any other aminoglycosides may also be contraindicated due to the known cross-sensitivity of patients to drugs in this class.

CEMEX GENTA bone cement is contraindicated in the presence of active or incompletely treated infection, at the site where the bone cement is to be applied.

Cemex Genta / Cemex Genta System bone cement is contraindicated where the loss of musculature or neuromuscular compromise in the affected limb would render the surgical procedure unjustifiable.

Cemex Genta / Centa System bone cement must be considered carefully in the presence of myastenia gravis.

There may be increased risk of ototoxicity from gentamicin, if other ototoxic drugs such as cisplatin (an antineoplatic agent) and vancomycin (another antibiotic) are given at the same time. There also appears to be a synergistic effect of loop diuretics, such as furosemide or ethactynic acid, and also loud noise, when combined with gentamicin.

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Section 4 Page 2 of 3

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KU33)5-96 page 393

Tecres Cemex® Genta bone cement Traditional 510(k)#K033596

Summary of Safety and Effectiveness

GENERAL DESCRIPTION - Substantial Equivalency Information

liquid component contains methylmethacrylate, N-N dimethyl p-toluidine, and The hydroquinone. The dry powder component contains polymethylinethacrylate, barium subhate, benzoyl peroxide and gentamicin sulphate.

Performance testing shows that the proposed devices are equivalent to the predicate and meet the requirements of ISO 5833 and ASTM 451-99.

PACKAGING

The packaging design for Cemex Genta System bone cement is identical to Cemex System bone cement (#K000943) except for the addition of an aluminum bag that serves as a moisture barrier. The packaging design for Centex Genta bone cement is identical to Cemex RX, ISOPLASTIC and XL bone cements (#K021715) except for the addition of an aluminum bag that serves as a moisture barrier.

STERILITY ASSURANCE

The powdered component is sterilized by ethylene oxide (EO) to a Sterility Assurance Level (SAL) of 106. The liquid component is sterilized by a membrane filtration technique to a SAL of 10-3.

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Section 4 Page 3 of 3

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes representing the three branches of government. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 1 0 2004

Ms. Lisa Simpson Senior Regulatory Representative Exactech. Inc. 2320 NW 66th Court Gainesville, Florida 32653

Re: K033596

Trade/Device Name: Cemex Genta / Cemex Genta System Bone Cement Regulation Number: 21 CFR 888.3027 Regulation Name: Polymethylmethacrylate (PMMA) bone cement Regulatory Class: II Product Code: LOD and MBB Dated: February 24, 2004 Received: February 25, 2004

Dear Ms. Simpson:

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 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 - Ms. Lisa Simpson

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 (301) 594-4639. 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 may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely vours.

Sincerely yours,

Mark A. Milken

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Tecres Cemex® Genta Bone Cement Indications for Use

510(k) Number: #K033596

Cemex Genta / Cemex Genta System Bone Cement Device Names:

INDICATIONS FOR USE

Cemex Genta / Centa System 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.

CONTRAINDICATIONS

Cemex Genta / Cemex Genta System bone cement is contraindicated in primary orthopaedic musculoskeletal surgical procedures.

Cemex Genta / Cemex Genta System bone cement is contraindicated in patients who are allergic or sensitive to any of its components, including Gentamicin Sulphate.

CEMEX GENTA bone cement is contraindicated in the presence of active or incompletely treated infection, at the site where the bone cement is to be applied.

Cemex Genta / Cemex Genta System bone cement is contraindicated where the loss of musculature or neuromuscular compromise in the affected limb would render the surgical procedure unjustifiable.

Cemex Genta / Cemex Genta System bone cement must be considered carefully in the presence of myastenia gravis.

There may be increased risk of ototoxicity from gentamicin, if other ototoxic drugs such as cisplatin (an antineoplatic agent) and vancomycin (another antibiotic) are given at the same time. There also appears to be a synergistic effect of loop diuretics, such as furosemide or ethacrynic acid, and also loud noise, when combined with gentamicin.

Prescription Use

X
——

Over the Counter Use

Use No

Please do not write below this line - use another page if needed.

Concurrence of CDRH/Office of Device Evaluation (ODE)

(Division Sign-Off)

Division of General, Restorative,
and Neurological Devices

rev. 02 18 04

510(k) Number_ K033596

Page 1 of 1

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.”