METALLIC INTRAMEDULLARY NAIL SYSTEM

{0}------------------------------------------------ # MAR 1 9 2014 Section 3 510 (k) Summary Project #: M0162013Ad ## Section 3 510(k) Summary This 510(k) Summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and Title 21, CFR Section 807.92. The assigned 510(k) Number: _K132078 - l. Date of Submission: 06/27/2013 - 2. Sponsor Identification Tianjin Walkman Biomaterial Co., Ltd No. 19, Technology Road, Tianjin Tianyu Science and Technology Garden JinghaiEast. Tianjin, P.R. China 301609 Establishment Registration Number: Not yet registered Contact Person: Ms. FengmeiRen Position: Management Representative Tel: +86-22-68660780 Fax: +86-22-68660776 Email: wm-rfm@126.com - 3. Submission Correspondent Ms. Diana Hong & Mr. Lee Fu Mid-Link Consulting Co.. Ltd P.O. Box 120-119 Shanghai, 200120, China Tcl: +86-21-22815850 Fax: 240-238-7587 Email: info@mid-link.net {1}------------------------------------------------ Project #: M0162013Ad - 4. Proposed Device Identification Proposed Device Trade Name: Metallic Intramedullary Nail System Classification Name: rod, fixation, intramedullary and accessories; Classification: II: Product Code:HSB; Regulation Number: 21 CFR888.3020; Review Panel: Orthopedic: Intended Use Statement: - · Simple, compound first- and second-degree tibial shaft fractures - · Pseudarthrosis and delayed union - 5. Predicate Device Identification 510(k) Number: K121312 Product Name: Intramedullary Nail System Manufacturer: Weigao Orthopaedic Device Co., Ltd - Device Description 6. The Metallic Intramedullary Nail System, is a temporary fixation intramedullary nail designed for fracture fixation and stabilization of the tibia. The system consists of intramedullary nail, locking screw, end cap and instruments. The intramedullary nail is available in a variety of lengths and diameters to meet assorted anatomical needs. Each of the nails is secured by a series of screws that pass through holes manufactured into the proximal and distal sections of each nail. - 7. Non-Clinical Test Conclusion Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards: ASTM F 1264-03(Reapproved 2007), Standard Specification and Test Methods for Intramedullary Fixation Devices {2}------------------------------------------------ #### Substantially Equivalent (SE) Conclusion 8. The following table compares the DEVICE to the predicate device with respect to intended use, technological characteristics and principles of operation, etc. | Item | Proposed Device | Predicate Device | | |-----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------| | Product Code | HSB | Same | | | Regulation No. | 888.3020 | Same | | | Class | II | Same | | | Classification Name | Rod, Fixation, Intramedullary And Accessories | Same | | | Intended Use | Simple, compound first- and second-degree tibial shaft fractures<br>Pseudarthrosis and delayed union | Same | | | Configuration | Nail, Screw and End cap | Same | | | Screw Feature | Single cortical fixation achieved by proximal threaded locking screw. | Same | | | Sterile | The devices are supplied non-sterile, it should be sterilized prior to use by professional and the sterilization should achieve SAL 1×10-6. | Same | | | Single Use | Yes | Same | | | Labeling | Conforms to 21 CFR 801 | Same | | | Physical<br>Specification | Nail | Proximal/Distal Diameter: φ10/φ8 mm, φ10/φ10 mm, φ10/φ9 mm<br>Length: 240 mm - 340 mm in 5 mm increments. | Proximal Distal Diameter: φ10/φ9 mm, φ10/φ10 mm, φ11/φ9 mm, φ11/φ10 mm, φ11/φ11 mm, φ12/φ12 mm, φ13/φ13 mm<br>Length: 240 mm - 465 mm in 5 mm increments. | | | Screw | Proximally threaded screw<br>Diameter: φ6 mm, Length: 20-75 mm | Proximally threaded screw<br>Diameter: φ4 mm, Length: 18-80 mm<br>Diameter: φ5 mm, Length: 26-100 mm<br>Diameter φ6 mm, Length: 18-100 mm | | | End Cap | Diameter: φ10 mm, Length: 16mm | Diameter: φ10 mm, Length: 14 mm<br>Diameter φ8 mm, Length: 11.5 mm, 16.5mm, 17.5mm, 21.5mm and 26.5mm | | Mechanical<br>Specification | Nail | Tested per ASTM F1264:2003 R2007 | Same | | | Screw | Tested per ASTM F1264:2003 R2007 | Same | | Material Specification | Titanium Alloy (Ti-6Al-4V ELI) | Same | | | | Conforms to ASTM F136 Standard<br>Specification for Wrought<br>Titanium-6Aluminum-4 Vanadium ELI(Extra<br>Low Interstitial) Alloy for Surgical Implant Applications (UNSB 56401) | Same | | Table 3-1 Comparison of Technology Characteristics {3}------------------------------------------------ ### Section 3 510 (k) Summary The proposed device is mainly different in dimension with the predicate device, but the mechanical test demonstrated the results of both devices are very similar. The proposed device. Metallic Intramedulary Nail System, is determined to be Substantially Equivalent (SE) to the predicate device, Intramedullary Nail System (K121312), in respect of safety and effectiveness. {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" in bold, uppercase letters. The text is centered and appears to be the heading of a document or publication. The font is a sans-serif typeface, and the overall appearance is clean and professional. Image /page/4/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 a stylized symbol that resembles a caduceus, a traditional symbol of medicine, with a staff and intertwined snakes. #### Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 March 19. 2014 Tianjin Walkman Biomaterial Co., Limited % Ms. Diana Hong General Manager Mid-Link Consulting Co., Limited P.O. Box 120-119 Shanghai, 200120, CHINA Re: K132078 Trade/Device Name: Metallic Intramedullary Nail System Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: Class II Product Code: HSB Dated: February 25, 2014 Received: February 27, 2014 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. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. 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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set {5}------------------------------------------------ ## 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. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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/MedicalDevices/Safety/ReportaProblem/default.htm 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/MedicalDevices/Resourcesfor You/Industry/default.htm. Sincerely yours, # Vincen官网 - S for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {6}------------------------------------------------ ### Project #:M0162013Ad ## Section 2 Indications for Use 510(k) Number: K132078 Device Name: Metallic Intramedullary Nail System Indications for Use: - · Simple, compound first- and second-degree tibial shaft fractures; · Pseudarthrosis and delayed union. OPRESCRIPTION USE (Part 21 CFR 801 Subpart D) 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) Casey L. Hanley, Ph.D. --- Division of Orthopedic Devices Page 1 of 1