Integrity Retractable Implant Inserter (6000127)

{0} **FDA** U.S. FOOD & DRUG ADMINISTRATION September 17, 2026 Anika Therapeutics, Inc. Calen Souther Manager, Regulatory Affairs 32 Wiggins Ave. Beford, Massachusetts 01730 Re: K261869 Trade/Device Name: Integrity Retractable Implant Inserter (6000127) Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: MBI Dated: August 13, 2026 Received: August 13, 2026 Dear Calen Souther: 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 (the 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 available 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. U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov {1} K261869 - Calen Souther Page 2 Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). Your device is also subject to, among other requirements, the Quality Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13485 clause 8.3 (Nonconforming product), ISO 13485 clause 8.5.2 (Corrective action), and ISO 13485 clause 8.5.3 (Preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and ISO 13485 clause 7.5) and document changes and approvals in the Medical Device File (ISO 13485 clause 4.2.3). 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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the Quality Management System Regulation (QMSR) (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory- {2} K261869 - Calen Souther Page 3 assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Christopher Ferreira, M.S. Assistant Director DHT6C: Division of Restorative, Repair, and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {3} # Indications for Use | Please type in the marketing application/submission number, if it is known. This textbox will be left blank for original applications/submissions. | | K261869 | ? | | --- | --- | --- | --- | | Please provide the device trade name(s). | | | ? | | Integrity Retractable Implant Inserter (6000127) | | | | | Please provide your Indications for Use below. | | | ? | | The Integrity Bone Staple Fixation System is indicated for the fixation of soft tissue grafts or reinforcement meshes to bone during rotator cuff repairs. | | | | | Please select the types of uses (select one or both, as applicable). | ☑ Prescription Use (21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C) | | ? | | Please select the age group(s) for which the device(s) is to be used. | ☐ Neonates/Newborns (Birth to < 29 days old) ☐ Infants (29 days old to < 2 years old) ☐ Children (2 years old to < 12 years old) ☐ Adolescents (12 years old to < 22 years old) ☐ Adults (22 years old and greater) | | ? | {4} K261869 ### 510(k) Summary The information contained herein is being provided in accordance with the requirements of 21 CFR 807.92(c). Date Prepared: July 13, 2026 Applicant: Anika Therapeutics, Inc. 32 Wiggins Ave. Bedford, MA 01730 USA Official Correspondent: Calen Souther, MS Manager, Regulatory Affairs Phone: (781) 457-9541 Email: csouther@anika.com Trade/Proprietary Name: Integrity™ Retractable Implant Inserter (6000127) Device Class: Class II Regulation Number: 21 CFR 888.3040 Product Code: MBI Predicate Device Information: Integrity Bone Staple Fixation System – K223860 - cleared May 22, 2023 Reason for 510(k) submission: The purpose of this Traditional 510(k) is to obtain clearance for the Integrity Retractable Implant Inserter, as a line extension of the instruments provided as part of Anika Therapeutics' Integrity™ Bone Staple Fixation System, for use in the fixation of soft tissue grafts and surgical meshes to bone. Device Description: The Integrity Retractable Implant Inserter is a sterile single use device that is intended for the fixation of soft tissue grafts or reinforcement meshes to bone during rotator cuff repair procedures. Its design is predicated on Anika's current Integrity staple delivery instrument. Specifically, the instrument is used to deliver a polyetheretherketone (PEEK) bone staple for the fixation of the Integrity Implant to the bone. Indications for Use: The Integrity Bone Fixation System is indicated for the fixation of soft tissue grafts or reinforcement meshes to bone during rotator cuff repairs. Page 1 of 2 {5} K261869 # Device Characteristics | | Integrity Retractable Implant Inserter | Integrity Bone Staple Fixation System (Bone Staple Delivery Instrument) | | --- | --- | --- | | 510(k) clearance | Subject Device | K223860 | | Manufacturer | Anika Therapeutics, Inc. | Anika Therapeutics, Inc. | | Regulation | 21 CFR 888.3040 | 21 CFR 888.3040 | | Class | 2 | 2 | | Product Code | MBI | MBI | | Indication for Use | The Integrity Bone Staple Fixation System is indicated for the fixation of soft tissue grafts or reinforcement meshes to bone during rotator cuff repairs. | The Integrity Bone Staple Fixation System is indicated for the fixation of soft tissue grafts or reinforcement meshes to bone during rotator cuff repairs. | | Materials | Stainless steel, polymer resins | Stainless steel, polycarbonate, ABS | | Single use | Yes | Yes | | Sterility | Sterile, Gamma | Sterile, Gamma | | Shelf-life | 1-year | 1-year | # Non-clinical Testing Non-clinical testing was conducted to evaluate the biocompatibility and performance of the subject device. The results of the testing were assessed against the predicate device to determine substantial equivalency for design, performance, and safety. Cytotoxicity, sensitization, irritation, acute systemic toxicity, and material mediated pyrogenicity testing were performed to evaluate biocompatibility. Instrument mechanical performance and visual/physical inspection determined the performance of the subject device. Final devices were subjected to bacterial endotoxin testing in accordance with USP <85>. | Method | Test Article | LAL Sensitivity | Endotoxin Limit | Results | | --- | --- | --- | --- | --- | | USP <85> Gel Clot Endotoxin | Ten (10) disassembled devices, each submerged in 100ml LAL reagent water (LRW), extracted for one (1) hour | 0.03 EU/mL | <20 EU/device | <12 EU/device Requirement of USP met. | # Clinical Data Clinical testing was deemed not necessary for demonstrating substantial equivalence to the predicate device. # Conclusion The test data and comparisons of the technological characteristics within this submission demonstrate that the subject device is substantially equivalent to the predicate device when used in accordance with the intended use. Page 2 of 2