MEMOMETAL INTRA-MEDULLARY BONE FASTENER, MODELS SMART TOE / X-FUSE

{0}------------------------------------------------ K070578 page id2 510k Premarket Notification Intra medulary implants MEMOMETAL TECHNOLOGIES JUL 26 2007 ## SECTION 5: 510(K) SUMMARY ## 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS As required by section 807.92(c) Submitter MEMOMETAL TECHNOLOGIES Campus de Ker Lann - Rue Blaise Pascal 35170 BRUZ - France Phone : + 33 (0)2 99 05 50 66 Fax :+ 33 (0)2 99 05 95 62 Contacts Gilles AUDIC Quality Manager Bernard PRANDI General Manager e-mail: gilles.audic@memometal.com bernard.prandi@memometal.com Preparation date 02/26/2007 MEMOMETAL INTRAMEDULARY ARTHRODESIS DEVICE Trade Name (SMART TOE & X-FUSE) INTRAMEDULARY BONE FASTENER Common Name Classification Name Smooth or threaded metallic bone fastener K022599 NEWDEAL K-Wire Legally marketed K964226 MEMORY STAPLE (LANDOS - DEPUY Inc) predicate devices Description MEMOMETAL INTRAMEDULARY MEMORY BONE FASTENER are single-use bone fixation appliances intended to be permanently implanted. Intramedulary memory bone fastener are a "double X-shape K-Wire" made of shape memory nickel titanium alloy. Intended Use The MEMOMETAL INTRA MEDULLARY 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 Inter-digital fusion of fingers and toes and small bones fusion Indication for use Performance data MEMOMETAL INTRAMEDULARY MEMORY BONE The FASTENER (SMART TOE & X-FUSE) 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. {1}------------------------------------------------ page 272 510k Premarket Notification Intra medulary implants MEMOMETAL TECHNOLOGIES ... : -- : | Substantial equivalence | The MEMOMETAL INTRAMEDULARY MEMORY BONE<br>FASTENER (SMART TOE & X-FUSE) are substantially<br>equivalent to their predicate device K-WIRE in terms of<br>intended use and indications for use, design and function and<br>their predicate device MEMORY STAPLE in term of material.<br>Any minor differences between these two devices do not raise<br>new questions of safety and effectiveness. | |-------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| |-------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| CONFIDENTIAL {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" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, rendered in a stylized manner. JUL 26 2007 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Memometal Technologies % Mr. Bernard Prandi General Manager Campus de Ker Lann - Rue Blaise Pascal Bruz, France F35170 Re: K070598 > Trade/Device Name: Memometal Intramedulary Arthrodesis Device Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HTY Dated: June 18, 2007 Received: June 21, 2007 Dear Mr. Prandi: 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. 100 - 100 - {3}------------------------------------------------ Page 2 - Mr. Benard Prandi 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 Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 the reporting 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 its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html. Sincerely vours. Sincerely yours, Вашаувишир Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ | 510k Premarket Notification | |-----------------------------------| | Intra medulary implants MEMOMETAL | | TECHNOLOGIES | ## INDICATIONS FOR USE 510(k) Number (if known): K070598 Device Name: MEMOMETAL INTRA MEDULARY BONE FASTENER (SMART TOE & X-FUSE) . Indications for Use: The MEMOMETAL INTRA MEDULLARY 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 AND/OR (Part 21 CFR 801 Subpart D) 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) Barbara Boudur Division of General, Restorative, and Neurological Devices 510(k) Number K070598 Page 10