ULTIMA ACETABULAR ROOF REINFORCEMENT RING

{0}------------------------------------------------ Image /page/0/Picture/3 description: The image shows the text "K980286" in a handwritten style. Below this, the words "Exhibit I" are printed in a serif font. The text appears to be part of a document or label, possibly indicating an exhibit number or identification code. APR 3 1998 # 510(k) Summary ULTIMA® Acetabular Roof Reinforcement Ring Johnson & Johnson Professional, Inc. 325 Paramount Drive Raynham, Massachusetts 02767 ### 1. Contact Person: Janet G. Johnson Associate Regulatory Affairs Specialist (508) 828-3466 #### 2. Device Information: | Proprietary Name: | ULTIMA® Acetabular Roof Reinforcement<br>Ring | |----------------------|------------------------------------------------------------------| | Common Name: | Acetabular Roof Reinforcement Ring | | Classification Name: | Hip joint metal/ polymer semi-constrained<br>cemented prosthesis | | Regulatory Class: | Class II, per 21 §CFR 888.3350 | | Product Code: | 87 IDI | #### 3. Indications for Use: The ULTIMA® Acetabular Roof Reinforcement Ring is indicated for use in total hip replacement procedures for patients suffering severe pain and disability due to structural damage in the hip joint from rheumatoid arthritis, osteoarthritis, posttraumatic arthritis, collagen disorders, avascular necrosis, and nonunion of femoral fractures. Use of the prosthesis is also indicated for patients with congenital hip dysplasia, protrusio acetabuli, slipped capital femoral epiphysis, and disability due to previous fusion, where bone stock is inadequate for other reconstructive techniques. The Ultima® Acetabular Roof Reinforcement Ring is secured in the prepared acetabulum using a combination of Polymethylmethacrylate (PMMA) bone cement, bone allograft, and cancellous screws to provide stabilization. {1}------------------------------------------------ # 4. Device Description: The ULTIMA® Acetabular Roof Reinforcement Ring is a support component for the reconstruction of the acetabulum and is composed of commercially pure titanium (cp Ti). The ULTIMA® Acetabular Roof Reinforcement Ring is a hemispherical shell with a mesh of screw holes covering the shell to allow for use with cancellous screws for additional stabilization. The ULTIMA® Acetabular Roof Reinforcement Ring is used in conjunction with the ULTIMA® UHMWPE Acetabular Cup and Augmented UHMWPE Cup, and is held into the prepared acetabulum using a combination of Polymethylmethacrylate (PMMA) bone cement, bone allograft, and cancellous screws to provide primary stabilization. The ULTIMA® Acetabular Roof Reinforcement Rings will be available in a range of designated sizes from 40mm through 62mm in 2mm increments. The nominal outer diameter of the ULTIMA® Acetabular Roof Reinforcement Ring is the same as the designated size. The instrumentation used for implanting the ULTIMA® Acetabular Roof Reinforcement Ring includes a drill guide, 70mm drill, flexible shaft, depth gauge, tap and screw clamp, hemispherical reamers and a universal screw driver. ### 5. Substantial Equivalence: The ULTIMA® Acetabular Roof Reinforcement Ring is substantially equivalent in terms of intended use, materials, design, sterilization method, and packaging to the Protek Roof Reinforcement Ring (K953578). The determination of substantial equivalence for this device was based on a detailed device description and conformance with voluntary performance standards, e.g. ASTM F-67. {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features the department's name arranged in a circular pattern around an emblem. The emblem is a stylized depiction of an eagle with its wings spread, symbolizing protection and service. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 3 1998 APR Janet G. Johnson, RAC Associate Regulatory Affairs Specialist Johnson & Johnson Professional, Inc. 325 Paramount Drive 02767-0350 Raynham, Massachusetts Re: K980286 ULTIMA® Acetabular Roof Reinforcement Ring Trade Name: Regulatory Class: II Product Code: JDI Dated: January 23, 1998 Received: January 26, 1998 Dear Ms. Johnson: We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ಡಿ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations. {3}------------------------------------------------ ### Page 2 - Janet G. Johnson, RAC This letter will allow you to begin marketing your device as described in your 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 and additionally 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 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html". Sincerely yours, foiolesa Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ 510(k) Number (if known) Device Name K980286 ULTIMA® Acetabular Roof Reinforcement Ring # Indications For Use The ULTMA® Acetabular Roof Reinforcement Ring is indicated for use in total hip replacement procedures for patients suffering severe pain and disability due to structural damage in the hip joint from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, avascular necrosis, and nonunion of femoral fractures. Use of the prosthesis is also indicated for patients with congenital hip dysplasia, protrusio acetabuli, slipped capital femoral epiphysis, and disability due to previous fusion, where bone stock is inadequate for other reconstructive techniques. The Ultima® Acetabular Roof Reinforcement Ring is secured in the prepared acetabulum using a combination of Polymethylmethacrylate (PMMA) bone cement, bone allograft, and cancellous screws to provide stabilization. (Please do not write below this line - Continue on another page if necessary) Concurrence of CDRH, Office of Device Evaluation (ODE) bcooles Prescription Use (Per 21 CFR §801.109) OR Over-the-Counter Use (Optional Format 1-2-96)