APEX INTRAMEDULLARY NAIL SYSTEM

{0}------------------------------------------------ # MAY 1 6 2002 000562 ### 510(k) PREMARKET NOTIFICATION SUMMARY OF SAFETY AND EFFECTIVENESS APEX Intramedullary Nail System #### Submission Information | Name and Address of the Sponsor Of the 510(k) Submission: | Magly Orthopedics, LLC<br>14241 NE Woodinville-Duvall Road, #415<br>Woodinville, Washington 98072<br>425.489.2057 Phone<br>425.482.0147 Fax | |-----------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------| | Contact Person: | Dave Stinson | | Date Summary Prepared: | February 2, 2002 | Device Identification | Proprietary Name: | APEX Intramedullary Nail System | |-------------------|-------------------------------------------------| | Common Name: | Intramedullary Fixation System | | Classification: | Intramedullary Fixation Rod<br>21 CFR §888.3020 | #### Predicate Device Identification The design and function of the APEX Intramedullary Nail System is substantially equivalent to that of the predicate Stryker Howmedica Osteonics Retrograde/Antegrade Femoral Nail, the predicate ACE AIM Titanium Nails (DePuy/ACE, a Johnson Company), and the Smith & Nephew TriGen Knee Nail. The APEX Intramedullary Nail System is similar to the listed predicate device in design, function, materials used, and indications for use. #### Device Description The APEX Intramedullary Nail System consists of intramedullary rods for fixation inside the canal of the tibia or femur. All the rods are cannulated and cylindrical in shape. The rods are available in a variety of diameters and lengths and have holes located the proximal and distal ends for fixation to bone by means of locking screws. An end cap is available. It screws into the threaded end of the nails to prevent bone ingrowth, which may hamper attachment of the extraction instrumentation. All components of the APEX Intramedullary Nail System are manufactured from titanium alloy (Ti-6Al-4V). > Magly Orthopedics, LLC APEX Intramedullary Nail System 23 {1}------------------------------------------------ # DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol consists of three stylized human profiles facing right, stacked on top of each other, with flowing lines suggesting movement or progress. Food and Drug Administratio 9200 Corporate Boulevard Rockville MD 20850 **MAY 1 6 2002** Magly Orthopedics, LLC c/o Mr. Dave Stinson 15009 NE 195th Street Woodinville, WA 98072 Re: K020562 Trade/Device Name: APEX Intramedullary Nail System Regulation Number: 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: II Product Code: HSB Dated: February 15, 2002 Received: February 20, 2002 Dear Mr. Stinson: 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. {2}------------------------------------------------ Page 2 - Mr. Dave Stinson 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 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" (21CFR Part 807.97). Other general information 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, Muriam C. Provost Car Celia Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ ## 3. Statement of Indications for Use Page 1 of 1 510(k) Number: 20560 Pending Device Name: APEX Intramedullary Nail System Indication(s) for Use: - · Low subtrochanteric fractures - · Pseudarthrosis and corrective osteotomies - Transverse fractures - Pathologic fractures, impending pathologic fractures, and tumor resections. - · Oblique and spiral fractures - Supracondylar fractures, including those with intra-articular extension - Segmental fractures - Ipsilateral femoral neck fractures - Comminuted fractures - Fractures proximal to total knee arthoplasty - · Fractures with bone loss - Fractures distal to a hip implant - · Nonunions and malunions. - Acute bone lengthening and shortening - Reamed and unreamed applications - High Supracondylar fractures, including those with intra-articular extension. Muriam C. Provost (Division Sign-Off) Division of General, Restorative and Neurological Devices 510(k) Number K026562 (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) Maqly Orthopedics, LLC APEX Intramedullary Nail System 14