(90 days)
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No
The description focuses on the mechanical properties and materials of a soft tissue fixation system, with no mention of AI or ML.
No.
The TenoTac® Soft Tissue Fixation System is explicitly described for attaching soft tissue to bone, making it a surgical fixation device rather than a device for treating or curing a disease or medical condition.
No
The device description states its purpose is for "soft tissue to bone fixation" using tacks and sleeves. This indicates a therapeutic or reconstructive function, not diagnostic.
No
The device description explicitly states it is comprised of physical components made from titanium alloy (tacks and sleeves) and is intended for surgical implantation. This is a hardware-based medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "for soft tissue to bone fixation." This describes a surgical procedure performed directly on a patient's body.
- Device Description: The device is a physical implant made of titanium alloy, designed to be surgically placed to attach soft tissue to bone.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, or tissue) outside of the body to provide information about a person's health. This device does not interact with specimens in this way.
The TenoTac® Soft Tissue Fixation System is a surgical implant used for musculoskeletal repair.
N/A
Intended Use / 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 reconstruction, mid and forefoot repair, hallux valgus repair, metatarsal ligament/tendon repair or reconstruction, Achilles tendon repair
Product codes (comma separated list FDA assigned to the subject device)
MBI
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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Foot & Ankle
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Side-by-side performance testing demonstrates the substantial equivalence of the TenoTac® Soft Tissue Fixation System to the JuggerKnot™ Soft Anchors.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
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.(b)
Classification. Class II.
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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
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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) |
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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.
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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.