DURACON X3 CS TIBIAL INSERT

{0}------------------------------------------------ | Duracon® X3TM CS Tibial Insert | | | MAY 11 2007 | |--------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|-------------| | Proprietary Name: | Duracon® X3TM CS Tibial Insert | | | | Common Name: | Knee Prosthesis | | | | Classification Name/Reference: | Knee joint patellofemorotibial<br>polymer/metal/polymer semi constrained<br>cemented prosthesis. 21 CFR §888.3560<br><br>Knee joint patellofemorotibial metal/polymer<br>porous coated uncemented prosthesis.<br>21 CFR §888.3565 | | | | Device Product Code: | 87 JWH, 87 MBH | | | | Proposed Regulatory Class: | Class II | | | | For Information contact: | Francisco Haro, Regulatory Affairs Specialist<br>Howmedica Osteonics Corp.<br>325 Corporate Drive<br>Mahwah, NJ 07430<br>Phone: (201) 831-5493<br>Fax: (201) 831-6038 | | | | Date Summary Prepared: | March 29, 2007 | | | # 510(k) Summary of Safety and Effectiveness ### Description: This submission is a line extension to the Duracon® Total Knee System for a tibial insert. Tibial inserts will be identical in design to the predicate tibial inserts of the Duracon® Total Knee System and manufactured from the same material as the Triathlon® and Scorpio® X3TM Tibial Inserts. ### Indications: The Durcaon® Total Knee System components included in this submission are intended for use in total knee arthroplasty to relieve pain and restore knee functions for indications such as: - Noninflammatory degenerative joint disease including osteoarthritis, traumatic . arthritis or avascular necrosis, - . Rheumatoid arthritis, - . Correction of functional deformity, - Revision procedures where other treatments or devices have failed, . {1}------------------------------------------------ - Post-traumatic loss of joint anatomy, particularly when there is patello-femoral . erosion, dysfunction or prior patellectomy; and, - Irreparable fracture of the knee ● These products are intended to achieve fixation with and without the use of bone cement. Substantial Equivalence: The Duracon® X3™ CS Tibial Inserts are substantially equivalent to the Duracon® Total Knee System, Triathlon® X3™, and Scorpio® X3TM Tibial Inserts in regards to intended use, design, materials, and operational principles as tibia components. The engineering analysis demonstrates that the subject components are substantially equivalent in strength to the predicate components. {2}------------------------------------------------ Image /page/2/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 an eagle or bird in flight, composed of three curved lines. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 MAY I 1 2007 Howmedica Osteonics Corp. % Mr. Francisco Haro Regulatory Affairs Specialist 325 Corporate Drive Mahwah, New Jersey 07430 Re: K070883 > Trade/Device Name: Duracon® X3TM CS Tibial Insert Regulation Number: 21 CFR 888.3565 Regulation Name: Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis Regulatory Class: Class II Product Code: MBH, JWH Dated: March 29, 2007 Received: March 30, 2007 Dear Mr. Haro: 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 {3}------------------------------------------------ ## Page 2 - Mr. Francisco Haro 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. 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 procced 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html. Sincerely vours. Barbara Bucher for Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ #### Indications for Use 510(k) Number (if known): K070883 Device Name: Duracon® X3TM CS Tibial Insert Indications for Use: The Durcaon® Total Knee System components included in this submission are intended for use in total knee arthroplasty to relieve pain and restore knee functions for indications such as: - . Noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis or avascular necrosis, - Rheumatoid arthritis, ● - Correction of functional deformity, ● - Revision procedures where other treatments or devices have failed, . - Post-traumatic loss of joint anatomy, particularly when there is patello-femoral . erosion, dysfunction or prior patellectomy; and, - � Irreparable fracture of the knee These products are intended to achieve fixation with and without the use of bone cement. Prescription Use Over-The-Counter Use X AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) > Concurrenge of CPRH, Office of Device Evaluation (ODE) envere mann Page 1 of 1 (Division Sign Off) Division of General, Restorative. and Neurological Devices 510(k) Number K070583 5