AAP LOQTEQ PROXIMAL LATERAL TIBIA PLATE 4.5 SYSTEM

{0}------------------------------------------------ aop Implantate AG oop LOQTEQ® Proximal Lateral Tibia Plate 4.5 System K113602 PAGE 1 OF 2 # Summary of Safety and Effectiveness | Sponsor: | aap Implantate AG<br>Lorenzweg 5<br>D-12099 Berlin Germany | |----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Company Contact:<br>Phone:<br>Fax: | Dipl.-Ing. Marc Seegers<br>+49-30-750-19 -192<br>+49-30-750-19 - 111 | | Date | November 28, 2011 | | Trade Name: | aap LOQTEQ® Proximal Lateral Tibia Plate 4.5 System | | Common Name: | Proximal Lateral Tibia Plate System | | Classification: | | | Classification Name<br>and Reference: | 21 CFR 888.3030 Single/multiple component metallic<br>bone fixation appliances and accessories - Class II and<br>21 CFR 888.3040 Smooth or threaded metallic bone fixation fastener -<br>Class II | | Device Product Code<br>and Panel Code: | Orthopedics/87/ HRS: Plate, Fixation, Bone<br>Orthopedics/87/ HWC: Screw, Fixation, Bone | | Predicate device: | 4.5 mm Titanium LCP® Proximal Tibia Plating System, Synthes (USA)<br>premarket notification K023802 (JAN 28 2003). | | Device Description: | Bone plates used for fixation, i.e., for treatment of bone<br>fractures and other bone injuries. Bone plates are fixed<br>with bone screws. Bone plates and bone screws are<br>implants.<br>The aap LOQTEQ® Proximal Lateral Tibia Plates 4.5 are anatomically<br>shaped osteosynthesis plates, which met in combination with the use of<br>special screws the function of a Internal Fixator. | | | The following products are required for application:<br>● LOQTEQ® Proximal Lateral Tibia Plate 4.5<br>● LOQTEQ® Cortical Screw 4.5, T25, self-tapping<br>● LOQTEQ® Cortical Screw 4.5, small head, T25, self-tapping<br>● Cortical Screw 4.5, self-tapping<br>● Cortical Screw 4.5, small head, self-tapping<br>● Instruments, Proximal Lateral Tibia Plate 4.5 | | Material: | Plates and Screws are made of titanium alloy according to ASTM F136 or<br>ISO 5832-3 | {1}------------------------------------------------ aap Implantate AG aap LOQTEQ® Proximal Lateral Tibia Plate 4.5 System K113602 PAGE 2 of 2 The aap LOQTEQ® Proximal Lateral Tibia Plate 4.5 System is intended for Indication: treatment of nonunions, malunions, and fractures of the proximal tibia, including simple, comminuted, lateral wedge, depression medial wedge, bicondylar combination of lateral wedge and depression, and fractures with associated shaft fractures. Substantial The Substantial Equivalence of the new device and the predicate device Equivalence: is based on similar intended use, design, functionality, components and materials in use. > Documentation including mechanical testing to show the substantial equivalence and safety and effectiveness has been provided with this submission. #### Performance Data (Non-Clinical and / or Clinical): Non-clinical tests have been performed and show the effectiveness and safety of the device: #### Summary of Non-clinical tests: Type of test: Fatigue implant tests with progressive loadings, representing worst case scenario with respect to clinical use. Assessment of test results: Substantial equivalence with respect to the mechanical performance of the aap system could be stated due to the test results gained. The subject device is safe and effective, and whose performance meets the requirements of its pre-defined acceptance criteria and intended uses. Documentation regarding the mechanical testing to show the substantial equivalence and safety and effectiveness has been provided with this submission. {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle or bird-like figure. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the bird. Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002 aap Implantate % Mr. Marc Seegers, Dipl .- Ing., Director QA/RA Lorenzweig 5 D-12099 Berlin Germany **OCT** 31 2012 Re: K113602 Trade/Device Name: aap LOQTEQ Proximal Lateral Tibia Plate 4.5 System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: HRS, HWC Dated: October 19, 2012 Received: October 22, 2012 ్ర Dear Mr. Seegers: 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 vour 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. Marc Seegers 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. product raination vonator post of your device on our labeling regulation (21 CFR Part 801), please rr you dostte opeofics ao ://AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please the Ocher Tot Doriett and Wisbranding by reference to premarket notification" (21CFR Part note the regalations 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 rou may 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, yours, For Melkerson 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 Statement 510(k) Number (if known): K113602 # Device Name: LOQTEQ® Proximal Lateral Tibia Plate 4.5 System ## Indications for Use: The aap LOQTEQ® Proximal Lateral Tibia Plates 4.5 System is intended for treatment of nonunions, malunions, and fractures of the proximal tibia, including simple, comminuted, lateral wedge, depression medial wedge, bicondylar combination of lateral wedge and depression, and fractures with associated shaft fractures. 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) Ashl (Division Sign-Oft) Division of Surgical, Orthopedic, and Restorative Devices Page 1 of 1 510(k) Number k113602