MEMOMETAL INTRA-MEDULLARY BONE FASTENER

{0}------------------------------------------------ ﻜﻢ ﺍﻟﺘﻲ ﺗﻜﻮﻥ ﺍﻟﻤﺴﺎﺣﺔ ﺍﻟﺘﻲ ﺗﻌﺘﺒﺮ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘ K112197 # SECTION 5: 510(K) SUMMARY NOV 1 7 2011 ﺮ ﺍﻟﻤ ## 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS As required by section 807.92(c) | Submitter | MEMOMETAL TECHNOLOGIES<br>Campus de Ker Lann - Rue Blaise Pascal<br>35170 BRUZ - France<br>Phone : + 33 (0)2 99 05 50 66<br>Fax :+ 33 (0)2 99 05 95 62 | |------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Contacts | Gilles AUDIC Quality Manager<br>Bernard PRANDI General Manager<br>e-mail: gilles.audic@memometal.com<br>bernard.prandi@memometal.com | | 510K number | K070598 | | Preparation date | 05/25/2011 | | Trade Name | MEMOMETAL INTRAMEDULLARY BONE FASTENER (SMART TOE / X-FUSE) new device designs | | Common Name | INTRAMEDULLARY BONE FASTENER | | Classification Name | Smooth or threaded metallic bone fastener | | Legally marketed predicate devices | K070598 MEMOMETAL Intramedullary Bone Fastener Smart Toe & X-Fuse | | Description | MEMOMETAL INTRAMEDULLARY MEMORY BONE FASTENER new device designs are single-use bone fixation appliances intended to be permanently implanted. Intramedullary memory bone fastener are a "double X-shape K-Wire" made of shape memory nickel titanium alloy. | | Intended Use | The MEMOMETAL INTRAMEDULLARY BONE FASTENER (SMART TOE / X-FUSE) are indicated for small bone reconstruction limited to inter-digital fusion of fingers and toes and small bones fusion | | Indication for use | The MEMOMETAL INTRAMEDULLARY BONE FASTENER (SMART TOE / X-FUSE) are indicated for small bone reconstruction limited to inter-digital fusion of fingers and toes and small bones fusion | | Performance data | The MEMOMETAL INTRAMEDULLARY MEMORY BONE FASTENER (SMART TOE & X-FUSE) new device designs conform to ASTM F564-02 (2006) Standard Specification and | | | Test Methods for Metallic Bone Staples and to ASTM F2063-05 | | | Standard Specification for Wrought Nickel-Titanium Shape | | | Memory Alloys for Medical Devices and Surgical Implants. | | Substantial equivalence | The MEMOMETAL INTRAMEDULLARY MEMORY BONE<br>FASTENER (SMART TOE & X-FUSE) new device designs are<br>substantially equivalent to their predicate device MEMOMETAL<br>INTRAMEDULLARY MEMORY BONE FASTENER (SMART TOE &<br>X-FUSE) (K070598) in terms of intended use and indications<br>for use, design and function and in term of material. Any<br>minor differences between these two devices do not raise<br>new questions of safety and effectiveness. | {1}------------------------------------------------ . . : {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & 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 abstract symbol resembling an eagle or bird in flight, composed of several curved lines. Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002 NOV 17 2011 Memometal Technologies % Mr. Gilles Audic Campus de Ker Lann - Rue Blaise Pascal 35170 BRUZ - France Re: K112197 Trade/Device Name: Memometal Intramedullary Bone Fastener (Smart Toe & X-Fuse) Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HTY Dated: October 20, 2011 Received: October 20, 2011 Dear Mr. Audic: 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. 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 {3}------------------------------------------------ Page 2 - Mr. Gilles Audic 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/ycm115809.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/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/ResourcesforYou/Industry/default.htm. Sincerely vours. Eunice Keith 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 # 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________ Device Name: MEMOMETAL INTRAMEDULLARY BONE FASTENER (SMART TOE & X-FUSE) . #### Indications for Use: The MEMOMETAL INTRAMEDULLARY BONE FASTENER (SMART TOE / X-FUSE) are indicated for small bone reconstruction limited to inter-digital fusion of fingers and toes and small bones fusion Prescription Use >| 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) Michael Owens for MXM Sign-Off Division of Surgical, Orthopedic, and Restorative Devices 510(k) Number K112197