MODIFICATION TO ONCOLOGY SALVAGE SYSTEM (OSS)

{0}------------------------------------------------ ## R = 4 2002 BIOMET CORPORATE HEADQUARTERS K020476 page 1 ## SUMMARY OF SAFETY AND EFFECTIVENESS | Sponsor: | Biomet, Inc.<br>56 East Bell Drive<br>P.O. Box 587<br>Warsaw, IN 46581-0587 | |----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Contact Person: | Tracy J. Bickel<br>(574) 267-6639 | | Proprietary Name: | Biomet® Oncology Salvage System | | Common Name: | OSS-K Diaphyseal Segments | | Classification Name: | Prosthesis, Hip, semi-constrained, metal/polymer,<br>cemented (888.3350, 87JDI)<br>Prosthesis, Knee, femorotibial, constrained, cemented,<br>metal/polymer (888.3510, 87KRO) | Substantially Equivalent Devices: Oncology Salvage System (OSS)- K002757 The Biomet® Oncology Salvage System offers a variety of component options for Device Description: treatment of patients that require proximal femoral, total femur, or proximal tibial replacements, as well as, resurfacing components for the proximal tibial and distal femur. There are twelve diaphyseal segment lengths available in 3cm, 4cm, and 5cm to 23 cm in 2cm increments. The diaphyseal segments are machined from wrought Ti-6AI-4V (ASTM F-1472). All the segments have a smooth satin finish. Intended Use: The Biomet® Oncology Salvage System offers a variety of component options for treatment of patients that require proximal femoral, distal femoral, total femur, or proximal tibial replacements, as well as, resurfacing components for the proximal tibial and distal femur. Indications: - Painful and disabled joint resulting from avascular necrosis, osteoarthritis, rheumatoid arthritis or traumatic 1) arthritis - Correction of varus, valgus, post traumatic deformity 2) - Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement 3) - 4) Ligament deficiencies - ર) Tumor resections - Treatment of non-unions, femoral neck, and trochanteric fracture of the proximal femur with head 6) involvement, unmanageable using other techniques - 7) Revision of previously failed total joint arthroplasty - 8) Trauma These devices are single use implants. These devices are for cemented use only MAILING ADDRESS P.O. Box 587 Warsaw, IN 46581-0587 1 SHIPPING ADDRESS 56 E. Bell Drive Warsaw, IN 46582 1 OFFICE 219.267.6639 FAX 219.267.8137 0064 E-MAIL biomet@biomet.com {1}------------------------------------------------ Biomet, Inc. Summary of Safety and Effectiveness - Page 2 OSS-K Diaphyseal Segments 020970 page 2 of 2 Summary of Technologies: The device's technological characteristics (materials, design, sizing, and indications) are similar to or identical to the predicate device. Non-Clinical Testing: Surface finish analysis and mathematical calculations were performed to establish substantial equivalence. Clinical Testing: None provided as a basis for substantial equivalence. All trademarks are property of Biomet, Inc. {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract symbol that resembles a stylized caduceus, which is a traditional symbol of medicine. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 APR = 4 2002 Ms. Tracy J. Bickel Regulatory Specialist Biomet Orthopedics, Inc. P.O. Box 587 Warsaw, IN 46581-0587 Re: K020970 Trade/Device Name: Oncology Salvage System-K Diaphyseal Segments Regulation Number: 21 CFR 888.3350, 21 CFR 888.3510 Regulation Name: Hip joint metal/polymer semi-constrained cemented prosthesis, Knee joint femorotibial metal/polymer constrained cemented prosthesis Regulatory Class: Class II Product Code: JDI, KRO Dated: March 25, 2002 Received: March 26, 2002 Dear Ms. Bickel: We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roviewed your beeemined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use surved in the encreate) 70 ttg. ... ] commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to conninered pror to rita 2011/2017 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 I ou may , arores or visions 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 11 your de roo is enable 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 r rease of acribed 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 or any I vith 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. {3}------------------------------------------------ Page 2 - Ms. Tracy Bickel This letter will allow you to begin marketing your device as described in your Section 510(k) I mis loter will and h your e FDA finding of substantial equivalence of your device to a legally premails in the 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). regulation on interes, "Historians on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html Sincerely yours, for Mark A Milheison Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ Page ***_*** of **_** 510(k) Number (if known): K020970 Device Name: OSS-k Diaphyseal Segments Indications for Use: The Oncology Salvage System offers a variety of component options for treatment of patients that require proximal femoral, distal femoral, total femur, or proximal tibial replacements, as well as, resurfacing components for the proximal tibial and distal femur. Indications: - 1) Painful and disabled joint resulting from avascular necrosis, osteoarthritis, rheumatoid arthritis or traumatic arthritis - 2) Correction of varus, valgus, post traumatic deformity - 3) Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement - 4) Ligament deficiencies - 5) Tumor resections - 6) Treatment of non-unions, femoral neck, and trochanteric fracture of the proximal femur with head involvement, unmanageable using other techniques - 7) Revision of previously failed total joint arthroplasty - 8) Trauma These devices are single use implants. ## These devices are for cemented use only. ## (PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109) OR Over-The-Counter Use (Optional Format 1-2-96) (Division Sign-Off) garing Division of General, Restorative and Neurological Devices 510(k) Number K020970