Extremity Medical Calcaneal Osteotomy Device

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 February 4, 2015 Extremity Medical, LLC Mr. Brian Smekal Director, Regulatory Affairs 300 Interpace Parkway, Suite 410 Parsippany, New Jersey 07054 Re: K143402 Trade/Device Name: Extremity Medical Calcaneal Osteotomy Device Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC, HRS Dated: November 25, 2014 Received: November 28, 2014 Dear Mr. Smekal: 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 - Mr. Brian Smekal 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" (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 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 vours. ## 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) K143402 (paqe 1/1) Device Name Extremity Medical Calcaneal Osteotomy Device Indications for Use (Describe) The Extremity Medical Calcaneal Osteotomy Device is intended for fixation of osteotomies of the calcaneus. Type of Use (Select one or both, as applicable) 2 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 A SEPARATE PAGE IF NEEDED. # FOR FDA USE ONLY Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) 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}------------------------------------------------ # 510(k) Summary of Safety and Effectiveness: ## Extremity Medical Calcaneal Osteotomy Device | Submitter: | Extremity Medical, LLC.<br>300 Interpace Parkway<br>Suite 410<br>Parsippany, NJ 07054 | |---------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Contact Person | Brian Smekal, MS, RAC<br>Director, Regulatory Affairs<br>Phone: (973) 588-8988<br>Email: bsmekal@extremitymedical.com | | Date Prepared | November 25, 2014 | | Trade Name | Extremity Medical Calcaneal Osteotomy Device | | Classification Name<br>and Number | Smooth or threaded metallic bone fixation fastener<br>21 CFR 888.3040 | | Product Code | HWC (screw, fixation, bone), HRS (plate, fixation, bone) | | Predicate Devices | K121349 - Extremity Medical Screw and Washer System (IO FiX)<br>K052614 - Arthrex Low Profile Plate and Screw System (Calcaneus<br>StepPlate)<br>K124022 - Speed Shift (Biomedical Enterprises) | | Device Description | The Extremity Medical Calcaneal Osteotomy Device is a bone fixation device<br>consisting of a bracket and lag screws and a set of instruments used for implant<br>site preparation and delivery. The bracket is offered in height sizes of 6mm to<br>13mm. The Calcaneal Osteotomy Device is intended for fixation of<br>osteotomies of the calcaneus. | | Indications for use | The Extremity Medical Calcaneal Osteotomy Device is intended for fixation of<br>osteotomies of the calcaneus. | | Statement of<br>Technological<br>Comparison | The Extremity Medical Calcaneal Osteotomy Device and predicate devices are<br>equivalent in terms of indications for use, design, and material mechanical<br>properties. | | Non-clinical Testing | Bench testing static and dynamic bending were performed and compared to the<br>predicate device. | | Clinical Testing | No clinical testing was performed. | | Conclusion | The Extremity Medical Calcaneal Osteotomy Device is substantially<br>equivalent to its predicate device. This conclusion is based upon indications<br>for use, principles of operation, design, and mechanical test data. |