TRAUSON INTRAMEDULLARY NAIL

{0}------------------------------------------------ ## Exhibit #B 510(k) Summary JAN 1 8 2009 This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92. The Assigned 510(k) Number is: K081230 ### 1.Subje ct Device Information Trade/Proprietary Name: Trauson Intramedullary Nail including Trauson Femoral Nail Trauson Retrograde Femoral Nail Trauson Retrograde Humeral Nail Common Name: Intramedullary Fixation Rod Classification Name: Rod, Fixation, Intramedullary and Accessories Device Class: II Product Code: HSB Regulation Number: 888.3020 Review Panel: Orthopedic Intended Use: Trauson Intramedullary Nail is intended to be implanted into the intramedullary canal of femur or humerus for alignment, stabilization, fixation of fractures caused by trauma or disease. #### 2. Sponsor Information TRAUSON (JIANGSU) MEDICAL INSTRUMENT CO., LTD. 31 Houcun Road, Niutang Town Changzhou, Jiangsu, 213163, CHINA Phone: +86-757-86280075 Fax: +86-757-86397179 #### Contact Person of the Submission: Ms. Diana. Hong Shanghai Mid-link Consulting Co., Ltd. Suite 8D, No. 19, Lane 999 Zhongshan No.2 Road(S) Shanghai, 200030, China · Phone: +86-21-64264467 x 278 Fax: +86-21-64264468 x 809 Email: Diana.hong@mid-link.net {1}------------------------------------------------ ### 3.Pr edicate Device K072161 Biomet Femoral Locking Nail System K050241 AOS Humeral Nail #### 4.De vice Description The Trauson Intramedullary Nail made of medic 11 grade 3 16L stainless steel that meet ASTM F138 - 08 Standard Specification for Wrought 18Chromium-14 Nickel-2.5Molybdenum Stainless Steel Bar and Wire for Surgical Implants. It is intended to be implanted into the intramedullary canal of femur or humerus for alignment, stabilization, fixation of fractures caused by trauma or disease. The subject devices are not provided sterile. No new materials are used in the development of this device. #### 5.T est Data The subject device material only contains Medic 11 grade 3 16L stainless steel that meets ASTM F138 - 08 Standard Specification for Wrought 18Chromium-14 Nickel-2.5Molybdenum Stainless Steel Bar and Wire for Surgical Implants, and the material is medical grade and widely used in the industry which requires no biocompatibility testing. However, the all conducted Biological Evaluation Tests are in compliance with the standards of ISO 10993, "Biological Evaluation of Medical Devices". The compatibility of all the component material in the finished product was provided. Bench tests of the applicant device are conducted to determine the Torsional properties. #### 6.Subst antially Equivalence The Applicant device has the same classification information, intended use, sterilization specifications, performance, biocompatibility, chemical specifications and similar physical and mechanical specifications with the predicate device. The only difference between applicant device and predicate device is some physical specifications variant which is too slight to influence the effectiveness and safety. No new question was raised. {2}------------------------------------------------ Image /page/2/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" in a bold, sans-serif font. The text is arranged on a single line and is centrally aligned. The words are capitalized, and the ampersand symbol (&) is used to connect "HEALTH" and "HUMAN". Image /page/2/Picture/12 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle. The eagle is black, and the text is also black. The logo is simple and recognizable. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Trauson (Jiangsu) Medical Instruments Co., Ltd. % Ms. Diana Hong Shanghai Midlink Business Consulting Co., Ltd. Lane 999, Zhongshan No. 2 Road, Suite 8D, No. 19 Shanghai CHINA 200030 JAN 1 8 2009 Re: K081230 Trade/Device Name: Trauson Intramedullary Nail -Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary Fixation Rod Regulatory Class: II Product Code: HSB Dated: January 9, 2009 Received: January 12, 2009 Dear Ms. Hong: 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 {3}------------------------------------------------ Page 2 - Ms. Diana Hong 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. 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html. Sincerely yours. Mark M. Millerson Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ Premarket Notification 510(k) Submission-Indications for Use Report No .: A20061014 # Exhibit #A Indication for Use 510(k) Number: K081230 Device Name: Trauson Intramedullary Nail Indications for Use: Trauson Intramedullary Nail is intended to be implanted into the intramedullary canal of femur or humerus for alignment, stabilization, fixation of fractures caused by trauma or disease. 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 OF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Mark A. Melkum (Division Sign-Off) Division of General, Restorative, and Neurological Devices Page I of Number K081230 াম ಿ