U1 HIP SYSTEM - BIPOLAR

{0}------------------------------------------------ # AUG 2 9 2005 K05 0269 #### g U1 Hip system -- Bipolar Summary ## 510(k) Summary of Safety and Effectiveness | Submitted By: | United Orthopedic Corporation<br>No. 57, Park Ave. 2, Science Park, Hsinchu, 300, Taiwan<br>Tel: 886-3-5773351<br>Fax: 886-3-5777156 | |---------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------| | Date | October 6th, 2004 | | Contact person | Gene Huang / Regulatory Affairs | | Device Name: | U1 Hip system - Bipolar | | Common Name: | Bipolar endoprosthesis | | Classification Name and<br>Reference: | 21CFR 888.3390 Prosthesis, Hip, Hemi-, Femoral,<br>Metal/Polymer, Cemented or Uncemented. | | Predicate Device: | Whiteside Biomechanics Inc- Bipolar femoral head (K981238) | #### Device Description: The U1 Hip system - Bipolar is designated as a hemiarthroplasty component and is to be used with United U1 hip stem (K994078) and U2 hip stem (K003237) of total hip replacement. It is a modular type of product system. The U1 Hip system - Bipolar has 23 sizes (40-62 mm in 1 mm increments) of option with a hemispherical design, easy snap-in and take out mechanism. The metallic outer shell is produced from casting Co-Cr-Mo alloy (ASTM F75). The plastic liner with a 26 mm inner diameter is machined from extruded UHMWPE bars (ISO 5834/1). The U1 26 mm femoral head (K994078) has four different neck lengths (+0, +3, +6, +9 mm), which can meet the various needs of patient. The inner femoral head will be pressed into the polyethylene liner firstly, and then the polyethylene liner with inner head will be pressed into the outer shell using a bipolar head assembly device in the operating room. ### Intended Use: The U1 Hip system - Bipolar is indicated in partial hip arthroplasty for reduction or {1}------------------------------------------------ #### g U1 Hip system – Bipolar relief of pain and/or improved hip function in skeletally mature patients with the following conditions: - Non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, 1. ankylosis, protrusio acetabuli, and painful hip dysplasia; - Inflammatory degenerative joint disease such as rheumatoid arthritis; 2. - Correction of function deformity; 3. - Revision procedure where other treatments or devices have failed; and 4. - Treatment of nonunion, femoral neck, and trochanteric fractures of the proximal femur 5. with head involvement that are unmanageable using other techniques. ### Performance: The U1 Hip system- Bipolar is similar to currently marketed bipolar systems. The maximum range of motion between the inner bearing liner and the hip stem exceeds 60 degrees in flexion. In addition, positive eccentricity design allows optimal transmission of load from the acetabular cup to the femoral head. A review of the mechanical test data indicated that the locking strength of this Bipolar system is strong enough to prevent locking mechanism failure in clinical use. {2}------------------------------------------------ Image /page/2/Picture/2 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The logo is black and white. AUG 2 9 2005 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Mr. Gene Huang Manager, Regulatory Affairs United Orthopedic Corporation No. 57, Park Ave. 2, Science Park Hsinchu, 300, Taiwan Re: K050269 Trade/Device Name: U1 Hip System- Bipolar Regulation Number: 21 CFR 888.3390 Regulation Name: Hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis Regulatory Class: II Product Code: KWY Dated: August 4, 2005 Received: August 8, 2005 Dear Mr. Huang: We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bected by the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreate) it stgmay 10 ttgmay commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to commerce prior to May 20, 1978, his occordance with the provisions of the Federal Food, Drug, devices that have been receired in assee approval of a premarket approval application (PMA). and Cosmetter rest (110) that de nevice, subject to the general controls provisions of the Act. The r ou may, diere, maxis of the Act include requirements for annual registration, listing of general controll provisions 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 If your device is elassified (tooral controls. Existing major regulations affecting your device can may be subject to back as a such as a may be and 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 lease be activities and i Dristian that your device complies with other requirements of the Act that I Dri has Intatutes and regulations administered by other Federal agencies. You must or uny r 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 Of It Fart 807), we systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic rorth in the quand of oyovisions (Sections 531-542 of the Act); 21 CFR 1000-1050. {3}------------------------------------------------ Page 2- Mr. Gene Huang This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to oegin maneting your and equivalence of your device to a legally premarket notheadon. The PDA mixing of basification 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 If you desire specific advice for your ac now as a months. Also, please not the regulation entitled, a Colliaci the Office of Complanes at (21 to the Part 807.97). You may obtain " Wisbranding by reference to premarker nouities in the Act from the Division of Small other general informational and Consumer Assistance at its toll-free number (800) 638-2041 or Manufacturers, international and Oolbanker v.blvww.fda.gov/cdrh/industry/support/index.html. Sincerely yours, Mark N. Melkerson Sar 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): K050269 Device Name: U1 Hip system- Bipolar Indications For Use: This device is indicated in partial hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions: - · Non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dvsplasia: - · Inflammatory degenerative joint disease such as rheumatoid arthritis; - · Correction of function deformity; - Revision procedures where other treatments or devices have failed; and - · Treatment of nonunion, femoral neck, and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques. Prescription Use (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 801 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 Sign-Off Division of General, Restorative, and Neurological Devices **510(k) Number** K050269