VERSABOND AB BONE CEMENT

{0}------------------------------------------------ # 510(K) SUMMARY OF SAFETY AND EFFECTIVENE ## APR 2 9 2004 ### VersaBond® AB Bone Cement | Submitter:<br>Submitter's address: | Smith & Nephew, Inc.<br>1450 Brooks Road<br>Memphis, TN 38116 | |-------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------| | Submitter's phone number:<br>Contact person:<br>Date summary prepared:<br>Trade or proprietary name:<br>Common or usual name: | 901-399-6487<br>David Henley<br>April 27, 2004<br>VersaBond® AB Bone Cement<br>Polymethylmethacrylate (PMMA) Bone Cement<br>(antibiotic loaded) | | Classification name and reference: | 21 CFR 888.3027, polymethylmethacrylate (PMMA) bone<br>cement - Class II | 1)evice product code and panel code: Orthopedics / 87 / LOD #### I Device Description r levice Description ' lersaBond' AB Bone Cement consists of two separate components: polymer powder and moratists, who The two components are packaged together and are pre-measured, sterlitzed components which, when nixed, form a radiopaque, rapidly setting bone cement. #### Device Intended Use VersaBond" AB Bone Cement with Gentamicin is indicated for the fixation of prostheses to living bone for velsion the second stage of a two-stage revision for total joint arthroplasty after the initial infection has been cleared. #### Technological Characteristics Techninogical Characteriler to VersaBond Bone Cement (i.e. non-antibiotic). Similarities include vel subono "Ab bone Canifor the bone cement, except that an antibiotic has been added to In e lefthical chemical considents to the Cement also shares similar indications for use and technological characteristics. With regard to the antibiotic, Palacos® G Bone Cement with Gentamicin (K030086), marketed by Biomet, Inc., is a predicate device that uses the identical, but common antibiotic. #### Substantially Equivalent Device - VersaBond® Bone Cement, K001160 and K033509 (without antibiotic) Smith & Nephew, Inc. � - vel. Society Domanic Rooms of R12193 (for use of gentamicin antibiotic) Smith & Nephew, Inc. � - Surgical Simplex P®, PMA N17004 (without antibiotic) Howmedica Osteonics, Inc. . - Palacos® G Bone Cement w/Gentamicin, K030086 Biomet, Inc. * - Palacos® R Bone Cement, PMA P810020 EM Industries, Inc. � #### Performance Characteristics r enomination and testing has indicated that VersaBond" AB Bone Cement is substantially equivalent to plain VersaBond® Bone Cement, Palacos R, and Simplex. #### VBABSumS&E {1}------------------------------------------------ Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around the perimeter. Inside the circle is an abstract image of an eagle. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 APR 2 9 2004 Mr. David Henley Senior Clinical/Regulatory Affairs Specialist Orthopedics Smith & Nephew, Inc. 1450 Brooks Road Memphis, Tennessee 38116 Re: K022688 K022088 Trade/Device Name: VersaBond™ AB Bone Cement Regulation Number: 21 CFR 888.3027 Regulation Name: Polymethylmethacrylate (PMMA) bone cement Regulatory Class: II Product Code: I.OD and MBB Dated: January 30, 2004 Received: February 5, 2004 Dear Mr. Henley: We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becalling in the device is substantially equivalent (for the indications felerenced above and nave determined ly marketed predicate devices marketed in interstate for use stated in the enorsale) to togally the enactment date of the Medical Device Amendments, or to comments prior to May 20, 1978, the enaordance with the provisions of the Federal Food, Drug, uevices mat nave been require approval of a premarket approval application (PMA). alle Cosmetic Act (71ct) that do not require appear al controls provisions of the Act. The r ou may, mercerere, manel 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 cither class II (Special Controls) or class III (PMA), it If your device is elassinou von ontrols. Existing major regulations affecting your device can they be subject to been as a segulations, Title 21, Parts 800 to 898. In addition, I'DA 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 r reaso be aarmade a determination that your device complies with other requirements of the Act that 1177 has intates and regulations administered by other Federal agencies. You must or any I 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 sct OFF . and 0977 . actime (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. {2}------------------------------------------------ Page 2 - Mr. David Henley This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will and in yourse FDA finding of substantial equivalence of your device to a legally premaince nedicate 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 If you acan's specific as noliance 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 yours, Mark N 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 {3}------------------------------------------------ K 022688 ## INDICATIONS for USE STATEMENT K022688 VersaBond® AB Bone Cement Indications for Use: VersaBond® AB Bone Cement with Gentamicin is indicated for the fixation of prostheses to living bone for use 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 *No* (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH Office of Device Evaluation (ODE) (Division Sign-Off) Division of General, Restorative, and Neurological Devices 510(k) Number KO 22688 Page 1 of