CEMEX SYSTEM GENTA FAST BONE CEMENT

{0}------------------------------------------------ K043403. 2320 NW 66TH COURI GAINESVILIE, FL 32653 352-377-1140 FAX 352-378-2617 ## Tecres Cemex® System Genta Fast bone cement Special 510(k) DEC: 2 8 2004 # Summary of Safety and Effectiveness | Trade Names: | Cemex System Genta Fast bone cement | |----------------------|----------------------------------------------| | Common Name: | Bone Cement | | Classification Name: | Polymethylmethacrylate (PMMA)<br>Bone Cement | : ### Legally Marketed Device for Substantial Equivalence Comparison: | Model | Manufacturer | 510(k) Number | |-----------------------------------|----------------|---------------| | Cemex Genta<br>Cemex System Genta | Tecres, S.p.A. | #K033596 | #### INDICATIONS FOR USE Cemex System Genta 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. #### CONTRAINDICATIONS Cemex System Genta Fast Bone Cement is contraindicated in primary orthopaedic musculoskeletal surgical procedures. Cemex System Genta Fast 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 System Genta Fast Bone Cement is contraindicated in the presence of active or incompletely treated infection, at the site where the bone cement is to be applied. rev. 12/09/04 Section 4 Page 2 of 4 {1}------------------------------------------------ ## Tecres Cemex® System Genta Fast bone cement Special 510(k) 352 377-1140 י FAX 352-378-26 ד ## Summary of Safety and Effectiveness Cemex System Genta Fast Bone Cement is contraindicated where the loss of musculature or neuromuscular compromise in the affected limb would render the surgical procedure unjustifiable. Cemex System Genta Fast Bone Cement must be considered carefully in the presence of mvastenia gravis. There may be increased risk of oto:oxicity 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. ### GENERAL DESCRIPTION - Substantial Equivalency Information The individual chemical constituents in Cemex System Genta Fast bone cement are identical to those in the predicate Centa / Cemex System Genta bone cement (#K033596). The liquid component contains methylmethacrylate, N-N dimethyl p-toluidine, and hydroquinone. The dry powder component contains polymethylmethacrylate, barium sulphate, benzoyl peroxide and gentamicin sulphate. The only difference is that the predicate Cemex Genta / Cemex Genta System has a 2.7:1 powder-to-liquid ratio compared to the 2.4:1 ratio the new Cemex System Genta Fast product. The powder-to-liquid ratio reduction results in a quicker setting time to accommodate various application techniques, Performance testing shows that the proposed device is equivalent to the predicate and meet the requirements of ISO 5833 and ASTM 451-99. Performance testing shows that the rate of gentamicin release is within the safety range and comparable to the predicate Cemex Genta. #### PACKAGING Cemex System Genta Fast bone cement is packaged similarly to the predicate Cemex System Genta bone cement. The device is contained into the same double blister pack used for the predicate. The blisters are sealed with Tyvek® lids. The double blister pack is positioned inside an aluminum bag. The outer packaging is a heavy weight cardboard box. ### MIXING & APPLICATION Use of Cemex System Genta Fast bone cement takes place in two consecutive stages. During the first stage, the glass ampoule containing the liquid monomer is broken to allow the component to flow into the chamber containing the powdered constituents. The device is then rev. 12/09/04 Section 4 Page 3 of 4 {2}------------------------------------------------ ## Tecres Cemex® System Genta Fast bone cement Special 510(k) # Summary of Safety and Effectiveness used as a closed manual mixing device. Mixing is accomplished by firmly striking the device against the palm of the hand and mating at each strike. Because no direct contact is made between the components and the use , volitile release into the local environment and possibility of contamination is minimized. In re second stage, the container is attached to an application gun device and used as a syringe while the cement is still in a semi-fluid state. The transparency of the mixing device provides for preliminary inspection of the suitability of the cement components and the visualization of he mixing and application stages as required by ISO 5833. Detailed instructions for use and pr >aution/warning information is outlined in the instruction leaflet provided with the product. ### STERILITY ASSURANCE The powdered component is steriliz. d by ethylene oxide (EO) to a Sterility Assurance Level (SAL) of 10 °. The liquid component is sterilized by a membrane filtration technique to a SAL of 10-3. rev. 12/09/04 Section 4 Page 4 of 4 {3}------------------------------------------------ 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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling a stylized eagle or bird in flight, composed of three curved lines. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 DEC 2 8 2004 Ms. Lisa Simpson Sr. Regulatory Representative Exactech, Inc. 2320 NW 66th Court Gainesville, Florida 32653 Re: K043403 Trade Name: Cemex System Genta Fast Bone Cement Regulation Number: 21 CFR 888.3027 Regulation Name: Polymethylmethacrylate (PMMA) bone cement Regulatory Class: II Product Code: LOD Dated: December 16, 2004 Received: December 20, 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. {4}------------------------------------------------ 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 (240) 276-0120. 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 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 yours, b. Mark A. Melkman 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 {5}------------------------------------------------ ### Tecres Cemex® System Genta Fast Bone Cement Indications for Use 510(k) Number: K043403 Device Names: Cemex System Genta Fast Bone Cement #### INDICATIONS FOR USE Cemex System Genta 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. #### CONTRAINDICATIONS Cemex System Genta Fast Bone Cement is contraindicated in primary orthopaedic musculoskeletal surgical procedures. Cemex System Genta Fast 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 System Genta Fast 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 System Genta Fast Bone Cement is contraindicated where the loss of musculature or neuromuscular compromise in the affected limb would render the surgical procedure unjustifiable. Cemex System Genta Fast 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. X Over the Counter Use Prescription Use Or 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. 12/09/04 Page 1 of 1 510(k) Number K043403