ACTIVE UNICOMPARTMENTAL KNEE SYSTEM

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the acronym "ASDM" in white text against a black background. The letters are blocky and slightly pixelated, giving them a somewhat retro or digital appearance. The text is centered and appears to be part of a logo or heading. MAY 17 2006 # 510(k) Summary (Revised) 510(k) K060412 ASDM Pty Ltd 2/12 Frederick Street St Leonards, NSW 2065 Australia Tel: +61 2 9439 4448 Fax: +61 2 9439 4441 Date: 1 May 2006 Affairs Manager. Submitted By : Submitted By: Trade Name: Classification Name: Prosthesis. knee joint, femorotibial, polymer/metal semi constrained cemented prosthesis - HRY Graham J Blucher, Quality and Regulatory Active Unicompartmental Knee System Common/Usual Name: Knee prosthesis, Unicompartmental. ## Substantial Equivalence: The Active Unicompartmental Knee is substantially equivalent to the Repicci II Unicondylar Knee, K971938. ### Product Description: ### Device es of the prop The Active Unicompartmental Knee System is a modular re-surfacing unicompartmental knee implant system, consisting of a metallic femoral component and a UHMWPE partial tibial component. Page 1/3 : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : {1}------------------------------------------------ ### Femoral Component The femoral component is an anatomic, asymmetrically designed prosthesis manufactured from cast cobalt/chrome/molybdenum alloy conforming to ASTM F75. The prosthesis was designed for optimal weight transmission and flexion, while providing maximum contact area to reduce material stress on the tibial component. The design incorporates a rotation of the condyle from flexion to extension aspects. From the medial lateral view, the condylar geometry has a radial inward and upward sweep in the coronal plane, which assists in maximizing the contact area. The design incorporates a central web, and two stabilizing pegs. It is available in five sizes, in both anatomical aspects. ### Tibial Component The tibial component is an asymmetrical component manufactured from Ultra High Molecular Weight Polyethylene that meets the requirements of ASTM F468. The components have a hemispherical surface, with a mild curvature. They incorporate a PMMA fixation groove around the periphery of the component, and a waffle pad base, and an angled stabilizing peg on the anterior half of the inferior surface. The tibial components are available in six sizes for each anatomical aspect, with three thickness available in each size. ### Intended Use/Indications for Use The Active Unicompartmental Knee System is a modular unicompartmental system that is intended to resurface one diseased or damaged condyle of a knee here the other condyle remains intact. It is intended to be used only with bone ts suffering from the following conditions: legenerative joint disease including osteoarthritis, traumatic ar necros nerative joint disease, excluding rheumatoid arthritis. ional deformity such as varus or valgus deformities. {2}------------------------------------------------ ### Testing The components of the Active Unicompartmental Knee System were tested by means of FEA mechanical testing, microstructural evaluation and visual and metrological examination. Testing consisted of a range of stress testing on both femoral and tibial components by means of FEA, fatigue testing of the femoral component, adhesion testing of the tibial component, and microstructure analysis of the femoral component. Further testing was conducted on the influence of heat treatment on the CoCrMo components, and the effect of varying the web height. to other unicompartmental knee designs, the Active When compared Unicompartmental knee system demonstrated similar performance characteristics. ### Bio-compatability The Active Unicompartmental Knee is manufactured from materials designed and used for surgical implant applications. The materials used are Chrome Cobalt Molybdenum alloy meeting the requirements of ASTM F75, and Ultra High Molecular Weight Polyethylene meeting the requirements of ASTM F648. Additionally a risk analysis, and an associated independent report on the effects of the manufacturing process on these materials, has indicated that the process is unlikely to impact on the safety of the materials used. ### Sterilization The metal components are sterilized by exposure to 25 to 42 kGy (2.5 to 4.2 Mrad) gamma radiation, as per the requirememnts of ISO 11137. The Polyethylene components are sterilized by exposure to Ethylene Oxide, as per the requirements of EN 550. ### Conclusion The performance testing has demonstrated that the Active Unicompartmental Knee System is substantially equivalent to the Repicci II Unicondylar Knee, K971938, and other similar marketed devices. {3}------------------------------------------------ Image /page/3/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, consisting of a staff with two snakes entwined around it. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" are arranged in a circular pattern around the caduceus. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 MAY 1 7 2006 Australian Surgical Design and Manufacture c/o Mr. James F. Logan Director General Medical Reports Exchange, Inc. 2530 Riva Road, Suite 308 Annapolis, Maryland 21401 Re: K060412 Trade/Device Name: Active Unicompartmental Knee System Regulation Number: 21 CFR 888.3530 Regulation Name: Knee joint femorotibial metal/polymer semi-constrained cemented prosthesis Regulatory Class: II Product Code: HRY Dated: May 02, 2006 Received: May 09, 2006 Dear Mr. Logan: 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 {4}------------------------------------------------ Page 2 – Mr. James F. Logan 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. 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/industry/support/index.html. Sincerely yours, Mark N. Melkerson, M.S. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {5}------------------------------------------------ # Indications for Use ### (Revised) 510(k) Number (if known): K060412 Device Name: Indications for Use: The Active Unicompartmental Knee System is a modular unicompartmental system that is intended to resurface one diseased or damaged condyle of a knee where the other condyle remains intact. It is intended to be used only with bone cement in patients suffering from the following conditions: - . Non-inflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis. - Inflammatory degenerative joint disease excluding rheumatoid arthritis . - Correction of functional deformity such as varus or valgus deformities. . Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Helut Remer us (Division Sign-Off) Division of General, Restorative, and Neurological Devices **510(k) Number** K060412