ODI 7.0MM CANNULATED SCREW SYSTEM

{0}------------------------------------------------ APR 0 1 2003 # SECTION 12: 510(k) SUMMARY Image /page/0/Picture/2 description: The image shows the logo for ODI Orthopedic Designs, Inc. The logo features a stylized "i" inside a circle, followed by the letters "ODI" in a bold, sans-serif font. Below the letters, the words "ORTHOPEDIC DESIGNS, INC." are printed in a smaller font size. # Premarket Notification 510(k) Summary of Safety and Effectiveness Information ### For Release Upon Request Only Date of Preparation: February 17, 2003 Regulatory Authority: Safe Medical Devices Act of 1990, 21 CFR 807.92 #### Company Name / Contact: | Company: | Orthopedic Designs, Inc. (ODi)<br>6965 1st Ave. North<br>St. Petersburg, FL 33710 | |----------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | A ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | Contact: Patrick Cosgrove (888) 635-8535 #### Establishment Registration Number: 1064129 Classification Name: Smooth or Threaded Metallic Bone Fixation Fastener -and- Single/multiple Component Metallic Bone Fixation Appliances and Accessories. 21 CFR § 888.3040 -- Smooth or Threaded Metallic Classification Reference: Bone Fixation Fastener 21 CFR § 888.3030 – Single/multiple Component Metallic Bone Fixation Appliances and Accessories. | Common Used Name: | Cannulated Screw | |----------------------------|-----------------------------------| | Device Product Code: | HWC and HTN | | Classification Panel: | 87- Orthopedic Devices | | Trade Proprietary Name: | ODi 7.0mm Cannulated Screw System | | Proposed Regulatory Class: | Class II | 30619 page 1 of 2 {1}------------------------------------------------ K030619 page 2 of 2 ### Device Description: The ODi 7.0mm Cannulated Screw System is used for fixation and stabilization of fractures of the proximal and distal femur until bony union can occur. The system consists of the following parts: - Cannulated screws of various lengths, which are positioned through bony ● fragments to provide stability to the fracture site during healing. - A washer which provides a bearing surface for the cannulated screw head against . the bone. The washer also prohibits migration of the screw head into the cortex. ODi will manufacture the implants from implant grade titanium alloys. #### Indications for Use: The ODi 7.0mm Cannulated Screw System will be used on indications that are common with presently marketed cannulated screw systems. The primary indications are for fixation/stabilization of stable fractures of the proximal femur including pertrochanteric fractures, basilar femoral neck fractures, subcapital femoral fractures, and combinations of these fractures. Other indications include intercondylar femoral fractures and tibial plateau fractures. The device is intended to stabilize fragments of the fracture until bony union can occur. #### Contra-indications for Use: The ODi 7.0mm Cannulated Screw System is not intended for use in patients with the following conditions: - 1. Active local Infection. - 2. Metal sensitivity or allergic reaction to foreign bodies. - 3. Loss of bone stock or insufficient bone quality to support the device. - 4. Obliterated femoral head, neck or trochanteric region. - 5. Use in the spine ### Substantial Equivalent Devices: Orthopedic Designs, Inc. believes the ODi 7.0mm Cannulated Screw System is substantially equivalent to the products described herein with respect to indications for use, device design, materials, method of manufacture and method of sterilization. Within the proposed class, the following devices are used as predicate devices for comparison: | aaP Implants, Inc | K990776 | |----------------------------------|---------| | Alphatec Mfg., Inc | -NA- | | Advanced Orthopaedic Solutions | K014185 | | DePuy/ACE, Inc. | K893512 | | Magly Orthopedics, LLC | K021662 | | Smith and Nephew | -NA- | | Stryker, Inc.-HowmedicaOsteonics | -NA- | | Synthes, Inc. | K021932 | | | K962011 | Each of these products are commercially available and marketed Class II devices indicated for similar use. {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an emblem featuring three stylized human profiles merging into a single form, often interpreted as representing the interconnectedness of health and human services. Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 APR 0 1 2003 Mr. Patrick J. Cosgrove Vice President Engineering and Product Support Orthopedic Designs, Inc. 6965 1st Avenue North St. Petersburg, FL 33710 Re: K030619 Trade/Device Name: ODi 7.0mm Cannulated Screw System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: HTN Dated: February 24, 2003 Received: February 27, 2003 Dear Mr. Cosgrove: 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 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) 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 general controls provisions 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 may be subject to such 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 that FDA has made 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 comply 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 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 - Mr. Patrick J. Cosgrove This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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, Mark McMillan 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}------------------------------------------------ #### DEVICE INDICATIONS FOR USE SECTION 5: Page 1 of 1 #### 510(k) Number: ODi 7.0mm Cannulated Screw System Device Name: #### Indications For Use: The ODi 7.0mm Cannulated Screw System will be used on indications that are common with presently marketed cannulated screw systems. The primary indications are for fixation/stabilization of stable fractures of the proximal femur including pertrochanteric fractures, basilar femoral neck fractures, subcapital femoral fractures, and combinations of these fractures. Other indications include intercondylar femoral fractures and tibial plateau fractures. The device is intended to stabilize fragments of the fracture until bony union can occur. #### Contra-Indications: The ODi 7.0mm Cannulated Screw System is not intended for use in patients with the following conditions: - 1. Active local Infection. - 2. Metal sensitivity or allergic reaction to foreign bodies. - 3. Loss of bone stock or insufficient bone quality to support the device. - 4. Obliterated femoral head, neck or trochanteric region. - 5. Use in the spine (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 510(k) Number - Mark A. Millerson is General, Restorative and Neurologica 5-1