CEMEX GENTA BONE CEMENT; CEMEX GENTA SYSTEM BONE CEMENT

K033596 · Exactech, Inc. · LOD · May 10, 2004 · Orthopedic

Device Facts

• Record ID: K033596
• Device Name: CEMEX GENTA BONE CEMENT; CEMEX GENTA SYSTEM BONE CEMENT
• Applicant: Exactech, Inc.
• Product Code: LOD · Orthopedic
• Decision Date: May 10, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3027
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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 Story

Cemex Genta/Cemex Genta System is a PMMA bone cement containing gentamicin sulphate for local antibiotic delivery. Used by orthopedic surgeons in operating rooms during the second stage of two-stage revision total joint arthroplasty. The device consists of a liquid component (methylmethacrylate, N-N dimethyl p-toluidine, hydroquinone) and a powder component (polymethylmethacrylate, barium sulphate, benzoyl peroxide, gentamicin sulphate). The components are mixed to form a cement paste, which is applied to fix prostheses to living bone. The addition of gentamicin provides local antibiotic release to the surgical site. The device benefits patients by providing structural fixation while delivering localized antibiotic therapy to manage potential residual infection in revision arthroplasty.

Clinical Evidence

Bench testing only. Performance testing demonstrated equivalence to the predicate device and adherence to ISO 5833 and ASTM 451-99 standards for bone cement physical and chemical properties.

Technological Characteristics

PMMA bone cement. Liquid: methylmethacrylate, N-N dimethyl p-toluidine, hydroquinone. Powder: polymethylmethacrylate, barium sulphate, benzoyl peroxide, gentamicin sulphate. Standards: ISO 5833, ASTM 451-99. Sterilization: Ethylene oxide (powder, SAL 10^-6), membrane filtration (liquid, SAL 10^-3). Packaging includes moisture-barrier aluminum bag.

Indications for Use

Indicated for fixation of prostheses to living bone in second stage of two-stage revision for total joint arthroplasty after initial infection clearance. Contraindicated in primary orthopaedic musculoskeletal procedures, patients with allergy/sensitivity to components (including Gentamicin Sulphate), history of hypersensitivity/toxic reactions to aminoglycosides, active/incompletely treated infection at application site, loss of musculature/neuromuscular compromise rendering surgery unjustifiable, and myasthenia gravis.

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 System (K000943)

Reference Devices

• Cemex RX (K021715)
• ISOPLASTIC bone cement (K021715)
• XL bone cement (K021715)

Submission Summary (Full Text)

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K03596 Page 143 P.2

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MAY 1 0 2004

2320 NW 6614 COURI GAINESVILLE, G. 3255.

352-371-1140 FAX [phone]

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

# Summary of Safety and Effectiveness

| Applicant/Consultant: | Exactech® Inc.<br>2320 N.W. 66th Court<br>Gainesville, Florida 32653 | |
|-----------------------|-------------------------------------------------------------------------------------------|------------------------------------------|
| | Phone:<br>Fax: | (352) - 377 - 1140<br>(352) - 378 - 2617 |
| | FDA Establishment # 1038671 | |
| Manufacturer: | TECRES S.p.A<br>Via Andrea Doria 10,<br>37066 Sommacampagna, Verona, Italia | |
| | FDA Owner number: # 9033624 | |
| Contact: | Gary J. Miller, PH.D.<br>Exec. Vice President of Research & Development<br>Exactech, 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 Cement<br>Cemex Genta System Bone Cement |
|----------------------|-----------------------------------------------------------|
| Common Name: | Bone Cement |
| Classification Name: | Polymethylmethacrylate (PMMA)<br>Bone Cement |

#### Levally Marketed Device for Substantial Equivalence Comparison:

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

#### INDICATIONS FOR USE

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.

#### 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.

rev. 05 05 04

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

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.

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.

rev. 05 05 04

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 [phone]. 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 [phone] or [phone] 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.

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 / 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.

or

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

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