DYNA LOCKING IM NAIL

{0}------------------------------------------------ K092771 Image /page/0/Picture/1 description: The image shows the logo for U & I Corporation. The logo is in black and white. The letters U and I are large and bolded, with an ampersand (&) between them. The word "CORPORATION" is to the right of the letters U & I. # 5. 510(k) Summary | Manufacturer: | U & I Corporation<br>529-1, Yonghyun-dong, Uijungbu<br>Kyunggi-Do, Korea 480-050<br>Gyeong-Je Kwon, Regulatory Affairs Specialist | DEC - 2 2009 | |----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------| | Sponsor: | U & I Corporation<br>529-1, Yonghyun-dong, Uijungbu<br>Kyunggi-Do, Korea 480-050 | | | Sponsor Contact: | Gyeong-Je Kwon, Regulatory Affairs Specialist | | | Date Prepared: | September 2, 2009 | | | Device Name: | Trade Name: Dyna Locking IM Nail™ | | | Common Name: | Intramedullary Fixation System | | | Classification Name: | Intramedullary Fixation Rod (HSB), per 21 CFR 888.3020 | | | Product Code: | HSB | | | Predicate Devices: | Grosse & Kempf Locking Nail System (K860756)<br>Universal Tibial Nail and Unreamed Tibial Nail (K914453)<br>Osteo IC Nail (K933340)<br>Delta II Femoral Nail (K981529)<br>T2 Femoral Nail (K081152) | | #### Description of Device: The Dyna Locking IM Nail™ consists of three types of intramedullary rods (Femoral Nail, Tibial Nail, Unreamed Tibial Nail), Locking Screw, and Nail Cap. The rods are available in a variety of diameters and lengths and have holes located at the proximal and distal ends for fixation to bone by means of locking screws. An Nail Cap screws into the threaded end of the nails to prevent bone ingrowth, otherwise newbone in the nail hamper to remove the nail. hewbone in the hairhamper to remove the hall. All components of the Dyna Locking IM Nail™ are single use device, supplied nonsterile and manufactured from titanium alloy (Ti-6AI-4V ELI) in accordance with ASTM 136. Dyna Locking IM Nail™ Image /page/0/Picture/10 description: The image shows the logo for U&I Corporation. The logo is black and white. The letters U&I are in a stylized font, with the ampersand (&) connecting the two letters. To the right of the letters is the word "CORPORATION" in a bold, sans-serif font. {1}------------------------------------------------ ## Intended Use: The Dyna Locking IM Nail™ is intended to be implanted into the intramedullary canal of femur or tibia for alignment, stabilization, fixation of fractures caused by trauma or disease. - · Proximal, middle and distal third femoral and tibial shaft fractures - · Severely comminuted, spiral and segmental fractures - · Nonunions and malunions - · Bone lengthening ## Substantial Equivalence: The Dyna Locking IM Nail™ is substantially equivalent to Grosse and Kempf Locking Nail System (K860756), Universal Tibial Nail and Unreamed Tibial Nail (K914453), Osteo IC Nail (K933340), Delta II Femoral Nail (K981529), T2 Femoral Nail (K081152) in design, performance, function and intended use. ### Dyna Locking IM Nail™ {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with a bird-like design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the caduceus. The seal is in black and white. #### Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002 DEC - 2 2009 U & I Corporation % Mr. Gyeong-Je Kwon Regulatory Affairs Specialist 529-1, Yonghyun-dong, Uijungbu Kyunggi-Do, Korea 480-050 Re: K092771 Trade/Device Name: Dyna Locking IM Nail" Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: Class II Product Code: HSB Dated: September 2, 2009 Received: September 9, 2009 #### Dear Mr. Kwon: 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 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); medical device reporting (reporting of medical {3}------------------------------------------------ Page 2 - Mr. Gyeong-Je Kwon device-related adverse events) (21 CFR 803); 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. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. 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) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html. Sincerely yours, Joxetu Image /page/3/Picture/6 description: The image contains a single, stylized letter 'S' in a handwritten font. The letter is slightly tilted to the right and appears to be drawn with a thick pen or marker, giving it a bold and prominent appearance. The background is plain and does not contain any other elements. Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ # Indications for Use Statement 510(k) Number (if known): K09277) Device Name: Dyna Locking IM Nail™ #### Indications for Use: The Dyna Locking IM Nail™ is intended to be implanted into the intramedullary canal of femur or tibia for alignment, stabilization, fixation of fractures caused by trauma or disease: - · Proximal, middle and distal third femoral and tibial shaft fractures - · Severely comminuted, spiral and segmental fractures - Nonunions and malunions - · Bone lengthening Prescription Use X Over-The-Counter Use AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Danetu for mym Division Sign-Off (Dwision Sign-Division of Surgical, Orthopedic, and Restorative Devices 510(k) Number K092771 **CORPORATION** Dyna Locking IM Nail™ Page 8 of 46