OSS-BODIES PROXIMAL TIBIAL SLEEVE

{0}------------------------------------------------ FEB 1 5 2006 K 060131/ # 510(k) Summary | Preparation Date: | January 16, 2006 | |----------------------|--------------------------------------------------------------------------------------------| | Applicant/Sponsor: | Biomet Manufacturing Corp. | | Contact Person: | Tracy Bickel Johnson- Manager, Regulatory Affairs | | Proprietary Name: | Orthopedic Salvage System*- OSS | | Common Name: | OSS Bodies-Proximal Tibial Sleeve | | Classification Name: | Prosthesis, Knee, femorotibial, constrained, cemented, metal/polymer<br>(888.3510, 87 KRO) | Legally Marketed Devices To Which Substantial Equivalence Is Claimed: Orthopedic Salvage System- OSS (K052685) Device Description: The Orthopedic Salvage System- ØSS offers a variety of component options Device Description. The other proximal femoral, distal femoral, total femur, or proximal for the treatments, as well as, resurfacing components for the proximal tibial and distal femur. ### Indications for Use: - 1 ) Painful and disabled joint resulting from avascular necrosis, osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved - Correction of varus, valgus, functional or post traumatic deformity 2) - 3) Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement - 4) Ligament deficiencies - 5) Tumor resections - 9) Treatment of non-unions, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques* - 7) Trauma - 8) Revision of previously failed total joint arthroplasty *Not applicable to Regenerex™ Ultra Porous Construct titanium knee augment usage, or any other knee component. These devices are single use implants. These devices are for cemented use only. ^* Formerly known as the Oncology Salvage System- OSS All trademarks are property of Biomet, Inc. {1}------------------------------------------------ 510(k) Summary Biomet Manufacturing Corporation OSS Bodies Page 2 of 2 Summary of Technologies: The designs, intended use, contraindications, and design Summary of Technologies: The designs, thenited asseptis, their predicate counterparts. This submission allows for additional material options for the OSS bodies. Non-Clinical Testing: An engineering analysis was performed on the modified and predicate Non-Cliffical resultig. An engineering andrysis was possible was functional within its intended use. Clinical Testing: Clinical testing was not required for the predicate device. Therefore, this submission contains no clinical testing. {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the logo for the Department of Health and Human Services, USA. The logo features a stylized image of three human profiles facing right, with flowing lines above them. The profiles and lines are all in black. The image is surrounded by a circular border with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" in black, uppercase letters. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 FEB 1 5 2006 Tracy Bickel Johnson, RAC Manager, Regulatory Affairs Biomet Manufacturing Corp. P.O. Box 587 Warsaw, Indiana 46581-0587 Re: K060131 Trade/Device Name: OSS – Bodies Proximal Tibial Sleeve Regulation Number: 21 CFR 888.3510 Regulation Name: Knee joint femorotibial metal/polymer constrained cemented prosthesis Regulatory Class: II Product Code: KRO Dated: January 17, 2006 Received: January 18, 2006 Dear Ms. Johnson: We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate 10 use stated in the encreated to to togally the enactment date of the Medical Device Amendments, or to commerce pror to May 20, 1978, are exactions of the Federal Food. Due, ucvices mat have been residentive in quire approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The I ou may, therefore, market the act include requirements for annual registration, listing of general controls provisions of ractice, 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 If your device is classified (see above) into Existing major regulations affecting your device can may be subject to back as a sateral Regulations, Title 21, Parts 800 to 898. In addition, FDA may be found in ther announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean Flease be advised that FDA 3 issualite or our device complies with other requirements of the Act that I Dri has intact a wond regulations administered by other Federal agencies. You must or any i edetal statutes and regulations sincluding, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CFN i at 607), adomig (21 CFR Part 820); and 1f applicable, the clectronic forth in the quinty of coursely of the Act); 21 CFR 1000-1050. {3}------------------------------------------------ Page 2 - Ms. Tracy Bickel Johnson This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to begin marketing your avvalence of your device to alegally premarket notification. The PDA midning of substantal equice 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 II you desire specific advice for your done at (240) 276-0120. Also, please note the regulation entitled, comaci the Office of Complance at (210) 216 of 210 Part 807.97). You may obtain "Misbranding by reserciece to premantee notifications of Sectifical of Small other general information on your responsibilities under the Act from the 1990s (28.00) other general Information on your responsion.cos and its toll-free number (800) 638-2041 or Manufacturers, International and Octibernet v://www.fda.gov/cdrh/industry/support/index.html. Sincerely yours, Mark N. Melkerson 04 Acting 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):_KOGO131 Device Name: OSS-Bodies Proximal Tibial Sleeve ## Indications For Use: - IlCacionis For OSC: 1) Painful and disabled joint resulting from avascular necrosis, osteoartment rainindi disubled Joint rosin arthritis where one or more compartments are involved - 2) Correction of varus, valgus, functional or post traumatic deformity - 27 Correction of varias, variable, varies, varier of throdesis, or previous joint replacement - 4) Ligament deficiencies - 5) Tumor resections - 5) Turnor resections 6) Treatment of non-unions, femoral neck fracture, and trochanteric fractures Treathicht of non antono/rement, unmanageable using other techniques* - 7) Trauma - 8) Revision of previously failed total joint arthroplasty *Not applicable to Regenerex™ Ultra Porous Construct titanium knee augment usage, or any other knee component. These devices are single use implants. These devices are for cemented use only. Prescription use x (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) Signature (Division Sign-Off) Division of General, Restorative, and Neurological Devices 510(k) Number k060131 Page 1 of 1