AVL HINGE KNEE SYSTEM

{0}------------------------------------------------ AUG 5 - 2005 K05/570, 1/1 BIOMET ## 510(k) Summary Applicant/Sponsor: Biomet Manufacturing Corp. Contact Person: Patricia Sandborn Beres Senior Regulatory Specialist Proprietary Name: AVL Hinge Knee System Common Name: Constrained Knee Classification Name: Knee joint, femorotibial, metal/polymer, constrained, cemented prosthesis (21 CFR 888.3510) Legally Marketed Devices To Which Substantial Equivalence Is Claimed: The AVL Hinge Knee System is ter System in Station Station States AVI, Hingo Koos System (K010774): Orth Legally Marketed Devices To Which Substantial Equit and Products AVL Hinge Knee System (K010774); Orthopedic Salvage substantially equivalent to the following Biomet products System (OSS™) (K002757); Finn® Knee System (K945028). Device Description: The AVL Hinge Knee System is composed of a modular femoral component that is joined to a Device Description: The AVL Hinge Khee System is culmpost of the between the femoral and tibial modular libia component by means of a yoke and an axle, A polychylene bearing modular tiblai component by means of a yorks and an alle the femoral component. Intended Use: The indications for use of the AVL Hinge Knee System are: - ended Use: The indications for use of the AVC Hinge Knee Oystem are. Painful and disabled joint resulting from avascular necrosis, osteoarthritis, heumatic 1. arthritis - Correction of varus, valgus or post traumatic deformity - 2. Correction of varus, valgus of post tradmatic deformly Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement - 3. Ligament deficiencies 4. - Tumor resections 5. - Tumor resections Treatment of non-unions, femoral neck and trochanteric fracture of the proximal femur with head involvement, ତ. unmanageable using other techniques - Revision of previously failed total joint arthroplasty 7. - Trauma 8. These devices are for cemented use only. Summary of Technologies: The technological characteristics (materials, design, sizing and indications) of the AVL and Characterial Child Marketin Hotlinette devices or other Summary of Technologies: The technological characteristics (matchae) (and of the may of the summity cleared devices. Hinge Knee System are similar to or identical to the prev Clinical and Non-Clinical Testing: None provided All trademarks are property of Biomet, Inc. | MAILING ADDRESS | P.O. Box 587<br>Warsaw, IN 46581-0587 | |------------------|---------------------------------------| | SHIPPING ADDRESS | 56 E. Bell Drive<br>Warsaw, IN 46582 | | OFFICE | 574.267.6639 | | FAX | 574.267.8137 | | 151 | | | E-MAIL | biomet@biomet.com | {1}------------------------------------------------ Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three curved lines representing its wings. The eagle is enclosed in a circle, and the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES USA" is written around the circle. The logo is black and white. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 AUG 5 - 2005 Ms. Patricia Sandborn Beres Senior Regulatory Specialist Biomet Manufacturing Corporation 56 East Bell Drive. P.O. Box 587 Warsaw, Indiana 46582 Re: K051570 Trade/Device Name: AVL Hinge Knee System Regulation Number: 21 CFR 888.3510 Regulation Name: Knee joint femorotibial metal/polymer constrained cemented prosthesis Regulatory Class: II Product Code: KRO Dated: June 13, 2005 Received: June 14, 2005 Dear Ms. Beres: 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. {2}------------------------------------------------ ## Page 2 – Ms. Patricia Sandborn Beres 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, s. Hype Rlvodn N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ ## Indications for Use 510(k) Number (if known): ___ Device Name: AVL Hinge Knee System Indications For Use:The indications for use of the AVL Hinge Knee System are: - form I or OSC. The Indications from avascular necrosis, osteoarthritis, - rheumatoid arthritis or traumatic arthritis - 2. Correction of varus, valgus or post traumatic deformity - 2. Correction of raiges of Feets, raigue of Ecotomy, arthrodesis, or previous joint replacement - 4. Ligament deficiencies - 5. Tumor resections - 5. Turnor reseotions 6. Treatment of non-unions, femoral neck and trochanteric fracture of the rreadmont of hon anions involvement, unmanageable using other techniques - 7. Revision of previously failed total joint arthroplasty - 8. Trauma These devices are for cemented use only These devices are for cemented use only Prescription Use *X* (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use **__** (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 Page 1 of 1 510(k) Number K059570