← Product Code [MBI](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/MBI) · K182898 # TenoTac Soft Tissue Fixation System (K182898) _Paragon 28, Inc. · MBI · Jan 14, 2019 · Orthopedic · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/MBI/K182898 ## Device Facts - **Applicant:** Paragon 28, Inc. - **Product Code:** [MBI](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/MBI.md) - **Decision Date:** Jan 14, 2019 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 888.3040 - **Device Class:** Class 2 - **Review Panel:** Orthopedic - **Attributes:** Therapeutic ## Intended Use The TenoTac® Soft Tissue Fixation System is intended to be used for soft tissue to bone fixation. Specific indications for the TenoTac® include: Foot & Ankle: Medial/lateral reconstruction, mid and forefoot repair, hallux valgus repair, metatarsal ligament/tendon repair or reconstruction, Achilles tendon repair ## Device Story TenoTac® Soft Tissue Fixation System is a metallic implant system for securing soft tissue to bone. Device consists of threaded titanium alloy tacks (male) and threaded sleeves (female). During surgery, the tack is passed through the near cortex and engages the far cortex to provide tension and compress soft tissue against bone. Used by surgeons in foot and ankle procedures. Benefits include stable fixation for ligament and tendon repairs. Performance verified via static pull-apart and axial pullout testing in bone analog material. ## Clinical Evidence Bench testing only. Performance characterized via static pull-apart and static axial pullout testing in bone analog material. Bacterial endotoxin testing performed using kinetic turbidimetric method to ensure limit of 20EU/Device. No clinical data required. ## Technological Characteristics Constructed from titanium alloy (Ti-6Al-4V ELI per ASTM F136). System comprises threaded tacks (male) and threaded sleeves (female) in various sizes. Fixation achieved via mechanical engagement of near and far bone cortices. Non-powered, manual surgical implant. ## Regulatory Identification A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system. ## Predicate Devices - Zimmer Biomet (formerly Biomet Sports Medicine) JuggerKnot™ Soft Anchors ([K110145](/device/K110145.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {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 in blue, with the words "U.S. FOOD & DRUG ADMINISTRATION" in blue as well. The FDA is a federal agency responsible for regulating and supervising the safety of food, drugs, and other products. Paragon 28, Inc. Eric Lintula Director of Regulatory Affairs 4B Inverness Court E, Suite 280 Englewood, Colorado 80112 Re: K182898 Trade/Device Name: TenoTac® Soft Tissue Fixation System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: MBI Dated: October 10, 2018 Received: October 16, 2018 Dear Mr. Lintula: We have reviewed vour 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/cdrb/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 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 {1}------------------------------------------------ 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, ff 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 medical devices and radiation-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, For Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) Device Name TenoTac® Soft Tissue Fixation System #### Indications for Use (Describe) The TenoTac® Soft Tissue Fixation System is intended to be used for soft tissue to bone fixation. Specific indications for the TenoTac® include: · Foot & Ankle: Medial/lateral reconstruction, mid and forefoot repair, hallux valgus repair, metatarsal ligament/tendon repair or reconstruction, Achilles tendon repair | Type of Use (Select one or both, as applicable) | | |------------------------------------------------------------|-----------------------------------------------------------| | 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 5. | Device Trade Name: | TenoTac® Soft Tissue Fixation System | |--------------------|-----------------------------------------------------------------------| | 510(k) Number: | K182898 | | Manufacturer: | Paragon 28, Inc.
4B Inverness Ct, E STE 280
Englewood, CO 80112 | | Contact: | Eric Lintula
Phone: 888-728-1888
elintula@paragon28.com | | Date Prepared: | October 10th, 2018 | | Common Name: | Soft Tissue Fixation Device | | Classification: | 21 CFR 888.3040 | | Class: | II | | Product Code: | MBI | ### Indications for Use: The TenoTac® Soft Tissue Fixation System is intended to be used for soft tissue to bone fixation. Specific indications for the TenoTac® include: - Foot & Ankle: Medial/lateral repair and reconstruction, mid and forefoot repair, . hallux valgus repair, metatarsal ligament/tendon repair or reconstruction, Achilles tendon repair ### Device Description: The TenoTac® Soft Tissue Fixation System is manufactured from titanium alloy (Ti-6Al-4V ELI per ASTM F136) and is comprised of specialized threaded tacks/male implants and associated threaded sleeves/female implants for attaching soft tissue to bone. The tacks and sleeves are available in various sizes and lengths to accommodate different bone sizes. ### Predicate Devices: The Zimmer Biomet (formerly Biomet Sports Medicine) JuggerKnot™ Soft Anchors device (K110145) serves as the predicate device. {4}------------------------------------------------ ### Predicate Comparison: ### Indications The subject and predicate devices are intended to be used for soft tissue to bone fixation. Both devices are indicated for use in the foot and ankle. All indications for the subject device are covered within the indications of the predicate. ## Technological Characteristics Both the subject and predicate constructs are designed to achieve temporary fixation of soft tissue to bone. In the case of the TenoTac®, the device goes through the near cortex and engages the far cortex to provide tension and compress the soft tissue and bone. In the case of the predicate device, the device is passed through the bone, and suture provides tension and compresses the soft tissue to the bone. The mechanical testing demonstrates that TenoTac® device is substantially equivalent to the predicate, and introduces no new issues of safety or effectiveness. ## Nonclinical Testing All necessary testing has been performed on representative TenoTac® Soft Tissue Fixation System devices to assure substantial equivalence to its predicate and demonstrate the subject device performs as intended. All testing was performed on finished devices. The device performance was characterized via static pull apart and static axial pullout testing in bone analog material. Bacterial endotoxin testing using the kinetic turbidimetric method was used for pyrogenicity testing to ensure an endotoxin limit of 20EU/Device. Clinical data are not needed to support the safety and effectiveness of the subject device. ### Conclusion Side-by-side performance testing demonstrates the substantial equivalence of the TenoTac® Soft Tissue Fixation System to the JuggerKnot™ Soft Anchors. The TenoTac® Soft Tissue Fixation System is substantially equivalent to the JuggerKnot™ Soft Anchors (K110145) with respect to its indications for use, design, and function. --- **Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/MBI/K182898](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/MBI/K182898) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com