MEMOMETAL IMPLANTS (K-SNAP & TI-FUSE)

{0}------------------------------------------------ K102072 510k Premarket Notification Osteosynthesis implants MEMOMETAL TECHNOLOGIES Revision 3, 10/11/2010 ### SECTION 5: 510(K) SUMMARY # NOV - 3 2010 ### 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 | | Preparation date | 07/19/2010 | | Trade Name | MEMOMETAL Implants (K-Snap® & Ti-Fuse®) | | Common Name | MEMOMETAL implants | | Classification Name | Smooth or threaded metallic bone fastener | | Product code | HTY | | Legally marketed predicate devices | K100736 SMT Schilling Metalltechnik GMBH Kirschner and<br>Guide wire<br>K022599 Newdeal K-Wire | | Description | MEMOMETAL implants are single-use bone fixation<br>appliances intended to be permanently implanted.<br>MEMOMETAL implants are available in 2 different designs:<br>- Snap-off pin, smooth with a stop and a sharp self drilling tip<br>- Notched with a T-shaped head. | | Intended Use | The MEMOMETAL implants (K-Snap® & Ti-Fuse®) are<br>indicated for fixation of bone fracture, for bone reconstruction<br>or arthrodesis in presence of appropriate immobilization. The<br>size of the implant should be adapted to the specific<br>indication. | | Performance data | Engeneering rationale containing a comparison of mechanical | | | properties of Ti-Fuse® and K-Snap® implants K100736 SMT | | | Schilling Metalltechnik GMBH Kirschner and Guide wire under | | | flexure loading (typical mechanical solicitation of the implants | | | during the osteosynthesis period) has been performed. | | | K-Snap® insertion testing in cortical bone has been | | | performed to demonstrate that premature breakage doesn't | | | occur. | | Substantial equivalence | The MEMOMETAL implants (K-Snap® & Ti-Fuse®) are | | | substantially equivalent to their predicate (K100736) SMT | | | Schilling Metalltechnik GMBH Kirschner and Guide wire and to | | | Newdeal K-Wire (K022599) in terms of intended use, design | | | and function. Any minor differences between these devices do | | | not raise new questions of safety and effectiveness. | Page 1 of 2 - {1}------------------------------------------------ 510k Premarket Notification Revision 3, 10/11/2010 + Osteosynthesis implants MEMOMETAL TECHNOLOGIES 2 of 2 {2}------------------------------------------------ ## DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus symbol. #### Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002 ### MEMOMETAL TECHNOLOGIES % Mr. Gilles Audic Quality Manager Campus de Ker Lann - Rue Blaise Pascal 35170 BRUZ - France NOV - 3 2010 Re: K102072 Trade/Device Name: MEMOMETAL osteosynthesis implants (K-Snap® & Ti-Fuse®) Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fasteners Regulatory Class: Class II Product Code: HTY Dated: September 3, 2010 Received: September 7, 2010 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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set {3}------------------------------------------------ Page 2 - Mr. Gilles Audic 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/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 vours. Sincerely yours, Mark McMillan Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ 510k Premarket Notification Osteosynthesis implants MEMOMETAL TECHNOLOGIES Revision 3, 10/11/2010 ### INDICATIONS FOR USE NOV - 3 2010 02072 510(k) Number (if known): ## Device Name: MEMOMETAL osteosynthesis implants (K-Snap® & Ti-Fuse®) Indications for Use: The MEMOMETAL implants (K-Snap® & Ti-Fuse®) are indicated for fixation of bone fracture, for bone reconstruction or arthrodesis in presence of appropriate immobilization. The size of the implant should be adapted to the specific indication. Prescription Use > (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) AND/OR Concurrence of CDRH, Office of Device Evaluation (ODE) Souters for mxn (Division Sign) Division of Surgical, Orthopedic. and Restorative Devices 510(k) Number K102072 left Page 10