FastFrame External Fixation System - Knee Spanning, FastFrame External Fixation System - Damage Control

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of a human figure, represented by three overlapping profiles facing to the right. The profiles are simple and abstract, creating a sense of unity and connection. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 November 2, 2015 Zimmer, Incorporated Sujith Kallur Regulatory Affairs Specialist P.O. Box 708 Warsaw, Indiana 46581-0708 Re: K151992 Trade/Device Name: FastFrame™ External Fixation System - Knee Spanning, FastFrame™ External Fixation System - Damage Control Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: KTT, JDW Dated: October 5, 2015 Received: October 7, 2015 Dear Sujith Kallur: 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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set {1}------------------------------------------------ Page 2 – Sujith Kallur 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 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/Resourcesfor You/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 Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below. #### 510(k) Number (if known) K151992 Device Name FastFrame™ External Fixation System - Knee Spanning Indications for Use (Describe) The FastFrame External Fixation System - Knee Spanning is indicated for use in treatment of long bone (distal femur, proximal tibia) fractures. Specifically, the system is intended for: - Stabilization of open or closed fractures about the knee, typically in the context of polytrauma or where open or alternative closed treatment is undesirable or otherwise contraindicated; - Arthrodesis and osteotomies with associated soft tissue problems about the knee; - Stabilization of limbs after removal of total knee arthroplasty for infection or other failure; - Stabilization of non-unions about the knee; and - Intraoperative temporary stabilization to assist with indirect reduction. Type of Use (Select one or both, as applicable) 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}------------------------------------------------ DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration ## Indications for Use Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below. 510(k) Number (if known) K151992 Device Name FastFrameTM External Fixation System - Damage Control Indications for Use (Describe) The FastFrame External Fixation System - Damage Control is indicated for use in treatment of mid-shaft long bone (femur, tibia) fractures. Specifically, the system is intended for: - Stabilization of open or closed fractures of the femur and tibia, typically in the context of polytrauma or where open or alternative closed treatment is undesirable or otherwise contraindicated; - Stabilization of non-unions; and - Intraoperative temporary stabilization to assist with indirect reduction. | Type of Use (Select one or both, as applicable) | | |--------------------------------------------------|---------------------------------------------| | 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." {4}------------------------------------------------ ## 510(k) Summary | Sponsor: | Zimmer, Inc.<br>P.O. Box 708<br>Warsaw, IN 46581-0708 | |-----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Contact Person: | Sujith M Kallur<br>Regulatory Affairs Specialist, Trauma Regulatory Affairs<br>Telephone: 574-453-6350<br>Fax: 574-871-8760 | | Date: | 07/16/2015 | | Trade Name: | FastFrame™ External Fixation System - Knee Spanning,<br>and FastFrame™ External Fixation System - Damage<br>Control | | Common Name: | External Fixation Frame Components | | Classification Names<br>and References: | Appliance, Fixation, Nail/Blade/Plate Combination,<br>Multiple Components (KTT) per 21 CFR 888.3030,<br>Single/multiple component metallic bone fixation<br>appliances and accessories and Pin, Fixation, Threaded<br>(JDW) per 21 CFR 888.3040, Smooth or threaded metallic<br>bone fixation fastener | | Classification Panel: | Orthopedics/87 | | Predicate Device(s): | XtraFix External Fixation System by Zimmer Inc.<br>K113383, cleared 6/26/2012 | | Purpose and<br>Device Description: | The purpose of this 510(k) is to obtain marketing<br>clearance for the new devices, the FastFrame External<br>Fixation System - Knee Spanning, and FastFrame<br>External Fixation System - Damage Control. The systems<br>consists of fixation half- pins attached to rigid clamps<br>connected by adjustable telescoping tubes (bars) and are<br>intended for use in the treatment of long bone fractures<br>that require external fixation. | | Intended Use/Indications for Use: | The FastFrame External Fixation System - Knee<br>Spanning is indicated for use in treatment of long bone | {5}------------------------------------------------ (distal femur, proximal tibia) fractures. Specifically, the system is intended for: > -Stabilization of open or closed fractures about the knee, typically in the context of polytrauma or where open or alternative closed treatment is undesirable or otherwise contraindicated; > - Arthrodesis and osteotomies with associated soft tissue problems about the knee; > - Stabilization of limbs after removal of total knee arthroplasty for infection or other failure; - Stabilization of non-unions about the knee; and - Intraoperative temporary stabilization to assist with indirect reduction. The FastFrame External Fixation System - Damage Control is indicated for use in treatment of mid-shaft long bone (femur, tibia) fractures. Specifically, the system is intended for: > -Stabilization of open or closed fractures of the femur and tibia, typically in the context of polytrauma or where open or alternative closed treatment is undesirable or otherwise contraindicated; - Stabilization of non-unions; and - Intraoperative temporary stabilization to assist with indirect reduction. Comparison to Predicate Device: Both the subject and predicate systems can be used to reduce and fix long bone anatomy. Both systems use bars, clamps, and fixation pins to achieve the clinical end result. Both systems allow for length distraction and polyaxial motion between clamp bodies. > The major difference between the subject and predicate systems is that predicate system frame needs to be built intra-operatively. The FastFrame External Fixation Systems contains a frame which comes with clamps and bars (telescoping tubes) pre-assembled, and are not dissassemblable by the end user. The subject FastFrame External Fixation Systems are provided in sterile convenience kits as compared to the predicate system that {6}------------------------------------------------ | | is provided non-sterile, and must be steam sterilized prior to use. | |-------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Performance Data (Nonclinical and/or Clinical): | Non-Clinical Performance and Conclusions: | | | <b>Performance Evaluation</b> – The mechanical testing confirmed that the subject devices perform substantially equivalent in full construct rigidity and interconnection performance as compared to the predicate device. In addition, the <i>FastFrame</i> External Fixation System – Knee Spanning and <i>FastFrame</i> External Fixation System - Damage Control were found to be MRI Conditional per FDA Guidance “Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment” issued on December 11, 2014. | | | Conclusions: The results demonstrate that the devices are safe and effective and substantially equivalent to the | predicate devices. Clinical Performance and Conclusions: Clinical data and conclusions were not needed for these devices to show substantial equivalence.