InCore® Lapidus Sterile Kits

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. May 24, 2019 Nextremity Solutions. Inc. Greg Denham Project Leader, Product Development 210 North Buffalo Street Warsaw, Indiana 46580 Re: K190231 Trade/Device Name: InCore® Lapidus Sterile Kits Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: HWC Dated: April 1, 2019 Received: April 1, 2019 Dear Greg Denham: 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 {1}------------------------------------------------ 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. 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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Shumaya Ali, MPH Assistant Director DHT6C: Division of Stereotaxic, Trauma and Restorative Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K190231 Device Name InCore® Lapidus Sterile Kits Indications for Use (Describe) The Nextremity Solutions InCore® Lapidus System is a three-part construct intended for internal fixation for First Metatarsocuneiform arthrodesis (also known as Lapidus or First Tarsometatarsal Fusion). | 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}------------------------------------------------ | 510(k) Summary | | |-------------------|------------------------------------------------------------------------------------------------------------------------------| | Prepared: | February 4, 2019 | | Submitter: | Nextremity Solutions, Inc.<br>210 North Buffalo Street<br>Warsaw, IN 46580 | | Contact: | Greg Denham<br>Project Leader, Product Development<br>greg.denham@nextremity.com<br>Phone: 732-383-7901<br>FAX: 574-966-1396 | | Proprietary Name: | InCore® Lapidus Sterile Kits | | Common Name: | Bone Screw System | | Classification: | 21 CFR §888.3040: Smooth or Threaded Metallic Bone Fixation Fastener;<br>Class II | | Product Code: | HWC | | Substantially | | ## Equivalent Devices: #### Device Description: The InCore® Lapidus System consists of a post and two headless compression screws. Posts are available in 28mm and 32mm lengths and in right and left orientations. Screws are available in a 3.5mm diameter and lengths of 24 to 60mm. The post is inserted into the medial cuneiform and compression screws are inserted into the first metatarsal and into the post to maintain apposition of the bones during fusion. A post plug screw is threaded into the top of the post after all components have been implanted to prevent tissue ingrowth into the post and facilitate removal, if needed. All implants are manufactured from color anodized Ti-6Al-4V alloy conforming to ASTM F-136. The current submission adds disposable instruments to the InCore® Lapidus System. The disposable instruments are packaged in sterile kits with the 28mm post and post plug screw implant. The implant components of the system are unchanged aside from the change in packaging of the 28mm posts and post plug screws. {4}------------------------------------------------ #### Intended Use / Indications: The Nextremity Solutions InCore® Lapidus System is a three-part construct intended for internal fixation for First Metatarsocuneiform arthrodesis (also known as Lapidus or First Tarsometatarsal Fusion). ### Summary of Technologies, Similarities/Differences: The InCore® Lapidus Sterile Kits are substantially equivalent to the predicate device in regards to their intended use and indications, material, design, sizes, and mechanical properties. The implant components of the subject device system are identical to those of the predicate device. While the predicate device was provided with re-usable, non-sterile instruments, the current device system is provided with disposable instruments which are packaged in sterile kits with the 28mm post plug implants. ### Non-Clinical Testing: The implant components of the InCore® Lapidus Sterile Kits are identical to the implant components This submission includes additional, disposable instruments. of the predicate device. A biocompatibility risk assessment and packaging validation was completed for the new instruments. Endotoxin testing using the Limulus amebocyte lysate (LAL) has been completed. The endotoxin limit is <10 EU total. ### Clinical Testing: Clinical testing was not necessary to demonstrate substantial equivalence of the InCore® Lapidus Sterile Kits to the predicate device. ### Conclusions / Substantial Equivalence: Differences between the subject device system and the predicate device system do not raise new types of safety and effectiveness questions. InCore® Lapidus Sterile Kits are substantially equivalent to the predicate device in regards to its intended use, material, design, sizes and mechanical properties.