ORTHOPEDIC SALVAGE SYSTEM- OSS

{0}------------------------------------------------ K052685 Image /page/0/Picture/1 description: The image shows the word "BIOMET" in a bold, sans-serif font. The letters are all capitalized and have a blocky, geometric design. The letters are arranged horizontally, with each letter clearly separated from the others. The word is likely a logo or brand name. 007 8 7 2002 ## 510(k) Summary | Applicant/Sponsor: | Biomet Manufacturing Corp. | |----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Contact Person: | Allison Koskey, Regulatory Affairs Specialist | | Proprietary Name: | Orthopedic Salvage System - OSS | | Common Name: | OSS Bodies | | Classification Name: | -Prosthesis, Hip, semi-constrained, metal/polymer, cemented<br>(888.3350, 87 JDI)<br>-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 (K002757) Device Description: The Orthopedic Salvage System- OSS offers a variety of component options for the treatment of patients that require proximal femoral, total femoral, total femur, or proximal tibial replacements, 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) - Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement 3) - 4) Ligament deficiencies - Turnor resections 5) - Treatment of non-unions, femoral neck fracture, and trochanteric fractures of the proximal 6) femur with head involvement, unmanageable using other techniques - 7) Trauma - 8) Revision of previously failed total joint arthroplasty These devices are single use implants. These devices are for cemented use only. Summary of Technologies: The designs, intended use, contraindications, and design specifications of the subject components are similar or identical to their predicate counterparts. This submission allows for additional sizing options for the OSS bodies. 135 Formerly known as the Oncology Salvage System- OSS All trademarks are property of Biomet, Inc. {1}------------------------------------------------ Vorwort Image /page/1/Picture/1 description: The image shows the word "BIOMET" in a stylized, blocky font. The letters are bold and outlined in black, with a white fill. The overall design is simple and geometric, giving the word a strong and modern appearance. Non-Clinical Testing: An engineering analysis was performed on the modified and predicate devices comparing their profiles. The results indicated that the device was functional within its intended use. Clinical Testing: Clinical testing was not required for the predicate device. Therefore, this submission contains no clinical testing. * Formerly known as the Oncology Salvage System- OSS All trademarks are property of Biomet, Inc. > MAHING ADDINERAL AND A 1000 1000 10000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000 Winster Provention of the more . Shuman sa kamuna and the country to the country While and service and the くりにはりした。 Station Pass Casts Cases Notes ■ 上一篇: 上一篇: 上一篇: 136 {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features an abstract image of an eagle with three stripes forming its body and wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" is arranged in a circular pattern around the eagle. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 OCT 27 2005 Allison Koskey Regulatory Specialist Biomet Manufacturing Corp. P.O. Box 587 Warsaw, Indiana 46581-0587 Re: K052685 Trade/Device Name: Orthopedic Salvage System - OSS Regulation Number: 21 CFR 888.3510 Regulation Name: Knee joint femorotibial metal/polymer constrained cemented prosthesis Regulatory Class: II Product Codes: KRO, JDI Dated: September 26, 2005 Received: September 28, 2005 Dear Ms. Koskey: 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 for ass saled in the exerces, 1976, the enactment date of the Medical Device Amendments, or 10 conniner 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). and Cosmetic Free (110) has the device, subject to the general controls provisions of the Act. The rou may a controls provisions of the Act include requirements for annual registration, listing of general obtable provinciting 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 rr your device is elaborned toontrols. Existing major regulations affecting your device can be found in the Codc 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 I rease be advisou that I bristian that your device complies with other requirements of the Act that + Dr Has Intactions and regulations administered by other Federal agencies. You must or any I edetal statuated and registments, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set Of N 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. {3}------------------------------------------------ Page 2 - Ms. Allison Koskey This letter will allow you to begin marketing your device as described in your Section 510(k) This icher will anow your to organ finding of substantial equivalence of your device to a legally premits tourication. The PPF midning of 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 11 you desire specific acriously 3 at (240) 276-0120. Also, please note the regulation entitled, Contact the Office of Computance in (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general informational and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet and odress http://www.fda.gov/cdrh/industry/support/index.html. Sincercly yours, Mark N. Melkerson 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):_KO526 85 Device Name: Orthopedic Salvage System - OSS Indications For Use: The OSS bodies are indicated for cemented use only in cases of: - 1) Painful and disabled joint resulting from avascular necrosis, osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved - 2) Correction of varus, valgus, functional or post traumatic deformity - 3) Correction of revision of unsuccessful osteotomy, arthrodesis, or previous ioint replacement - 4) Ligament deficiencies - 5) Tumor resections - 6) 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 Prescription use __X (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use 1 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 X052685 Page 1 of 1