TiTHON Staple with OsseoTi Technology

{0}------------------------------------------------ Image /page/0/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 featuring three stylized human profiles facing to the right, stacked on top of each other. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 Biomet Manufacturing Corporation Ms. Patricia Sandborn Beres Senior Regulatory Specialist 56 Bell Drive Warsaw. Indiana 46580 October 2, 2015 Re: K151615 Trade/Device Name: TiTHON Staple with OsseoTi Technology Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: JDR Dated: September 8, 2015 Received: September 10, 2015 Dear Ms. Beres: 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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in {1}------------------------------------------------ Page 2 - Ms. Patricia Sandborn Beres 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 Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education 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 yours, # Mark N. Melkerson -S Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration # Indications for Use 510(k) Number (if known) K151615 Device Name TiTHON Staple with OsseoTi Technology Indications for Use (Describe) - · Fracture and osteotomy fixation and joint arthrodesis of the hand and foot. - · Fixation of proximal tibial metaphysis osteotomy - · Hand and foot bone fragment and osteotomy fixation and joint arthrodesis - · Fixation of small bone fragments (i.e. small fragments of bone which are not comminuted to the extent to preclude staple placement). These fragments may be located in long bones such as the femur, fibula, and tibia in the lower extremities; the humerus, ulna or radius in the upper extremities; the clavicle and in flat bone such as the pelvis, scapula and sternum. X Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) ### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ BIOMET # 510(k) Summary In accordance with 21 CFR §807.92 and the Safe Medical Devices Act of 1990, the following information is provided for the TiTHON Staple with OsseoTi Technology 510(k) premarket notification. The submission was prepared in accordance with the FDA guidance document, 'Format for Traditional and Abbreviated 510(k)s', issued on August 12, 2005. | Sponsor: | Biomet Inc.<br>56 East Bell Drive<br>PO Box 587<br>Warsaw, IN 46581<br>Establishment Registration Number: 1825034 | |-----------------|---------------------------------------------------------------------------------------------------------------------------------------------------------| | Contact: | Patricia S. Beres<br>Senior Regulatory Specialist<br>(574) 257-6639 extension 1278 | | Date: | September 29, 2015 | | Subject Device: | Trade Name: TITHON Staple with OsseoTi Technology<br>Common Name: Bone Staple<br>Classification Name:<br>• IDB– Staple, Fixation, Bone (21 CFR888.3030) | #### Legally marketed devices to which substantial equivalence is claimed: - Speed™, Speed Shift™, Speed Titan™, Speed Arc™ - Biomedical Enterprises, Inc. -K142292 ### Device Description The TiTHON Staples with OsseoTi Technology are long-term fixation staple implants. TiTHON Staples are available in widths of 15, 20 and 25mm, with leg lengths of 7, 10, 15, 20and 20mm. OsseoTi is a porous metal construct made of a Ti-6Al-4V alloy. The porous architecture mimics the porous structure of human cancellous bone. #### Intended Use and Indications for Use The TITHON OsseoTi Staple indications for use are: - Fracture and osteotomy fixation and joint arthrodesis of the hand and foot. - Fixation of proximal tibial metaphysis osteotomy - Hand and foot bone fragment and osteotomy fixation and joint arthrodesis - Fixation of small bone fragments (i.e. small fragments of bone which are not comminuted to the extent to preclude staple placement). These fragments may be located in long bones such as the femur, fibula, and tibia in the lower extremities; the humerus, ulna or radius in the upper extremities; the clavicle and ribs; and in flat bone such as the pelvis, scapula and sternum. {4}------------------------------------------------ ## Summary of Technological Characteristics The rationale for substantial equivalence is based on consideration of the following characteristics: - Intended Use: The subject device and the predicate device are both intended for bone fixation - Indications for Use: The subject device and the predicate have identical indications for use - Materials: Both devices are manufactured from titanium alloy - Design Features: The subject device has similar design features to that of the predicate - . Sterilization: Both devices are provided sterile by gamma irradiation ### Summary of Performance Data (Nonclinical and/or Clinical) - Non-Clinical Tests - o Mechanical testing has been performed in keeping with ASTM F564 Standard Specification and Test Methods for Metallic Bone Staples - . Clinical Tests - o No clinical testing was provided to establish substantial equivalence ### Substantial Equivalence Conclusion The proposed device has similar technological characteristics to the predicate, and the information provided demonstrates that any differences do not raise new questions of safety and effectiveness and that the proposed device is at least as safe and effective as the legally marketed predicate device.