(262 days)
No
The summary describes a mechanical soft tissue fixation device and does not mention any AI or ML components or functionalities.
No
The device is described as an all-suture soft tissue fixation device intended for fixation of tissue to tissue, and its indications include various repairs and reconstructions. This indicates a surgical implant or fixation device, which is restorative or supportive, rather than directly applying a therapeutic effect (like a drug or radiation therapy).
No
The device is described as a "Plantar Plate Repair System" intended for "fixation of tissue to tissue" and mentions "pullout testing," indicating it is a surgical implant for repair, not a diagnostic tool.
No
The device description explicitly states it includes an "all-suture soft tissue fixation device" which is a physical implant, not software.
Based on the provided information, the Paratrooper™ Plantar Plate Repair System is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states "fixation of tissue to tissue to tissue" for various foot and ankle repairs. This is a surgical device used in vivo (within the body) for structural support and repair.
- Device Description: The description of an "all-suture soft tissue fixation device" further confirms its role as a surgical implant.
- Lack of IVD Characteristics: There is no mention of analyzing samples from the human body (like blood, urine, tissue) to provide diagnostic information. IVDs are used to diagnose diseases or conditions, monitor treatments, or screen for health issues.
Therefore, the Paratrooper™ Plantar Plate Repair System is a surgical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Paratrooper™ Plantar Plate Repair System is intended for fixation of tissue to bone and tissue to tissue. Specific indications:
Foot/ankle:
• Lateral Stabilization
• Medial Stabilization
• Achilles Tendon Repair
• Metatarsal Ligament and Tendon Repair
• Hallux Valgus Reconstruction
• Digital Tendon Transfers
• Mid-foot Reconstruction
• Plantar Plate Repair
Product codes (comma separated list FDA assigned to the subject device)
MBI
Device Description
The Paratrooper™ Plantar Plate Repair System includes an all-suture soft tissue fixation device. The suture implant comes in one size and is provided attached to a needle.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Foot/ankle
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use (Part 21 CFR 801 Subpart D)
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
All necessary testing has been performed on representative Paratrooper™ Plantar Plate Repair System components 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 pullout testing. Additional testing includes pyrogenicity, biocompatibility and sterilization. Clinical data are not needed to support the safety and effectiveness of the subject device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
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).
Not Found
§ 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, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
January 24, 2020
Paragon 28, Inc. Eric Lintula Director of Regulatory Affairs 4B Inverness Ct. E, STE 280 Englewood, Colorado 80112
Re: K191227
Trade/Device Name: Paratrooper™ Plantar Plate Repair System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: MBI Dated: December 23, 2019 Received: December 23, 2019
Dear Mr. Lintula:
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
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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 https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-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/medicaldevices/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-device-advice-comprehensive-regulatoryassistance/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,
for
Laura Rose, Ph.D. Acting Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K191227
Device Name
Paratrooper™ Plantar Plate Repair System
Indications for Use (Describe)
The Paratrooper™ Plantar Plate Repair System is intended for fixation of tissue to tissue to tissue. Specific indications:
Foot/ankle:
- · Lateral Stabilization
- · Medial Stabilization
- · Achilles Tendon Repair
- · Metatarsal Ligament and Tendon Repair
- · Hallux Valgus Reconstruction
- Digital Tendon Transfers
- Mid-foot Reconstruction
- · Plantar Plate Repair
| 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)
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510(k) Summary
| Date: | May 3rd, 2019 |
|---|---|
| 510(k) Number: | K191227 |
| Sponsor: | Paragon 28, Inc. |
| 14445 Grasslands Dr. | |
| Englewood, Colorado 80112 | |
| Phone: (888) 728-1888 | |
| Fax: (888) 728-1220 | |
| Sponsor contact: | Eric Lintula, Senior Director of Quality and Regulatory Affairs |
| Trade Name: | Paratrooper™ Plantar Plate Repair System |
| Regulatory Class: | Class II |
| Regulation, | |
| Product Code, | |
| Classification, and | |
| Common Name: | 888.3040, MBI, Fastener, Fixation, Nondegradable, Soft Tissue |
| Device | |
| Description: | The Paratrooper™ Plantar Plate Repair System includes an all- |
| suture soft tissue fixation device. The suture implant comes in | |
| one size and is provided attached to a needle. | |
| Indications for | |
| Use: | The Paratrooper™ Plantar Plate Repair System is intended for |
| fixation of tissue to bone and tissue to tissue. Specific | |
| indications: | |
| Foot/ankle: | |
| • Lateral Stabilization | |
| • Medial Stabilization | |
| • Achilles Tendon Repair | |
| • Metatarsal Ligament and Tendon Repair | |
| • Hallux Valgus Reconstruction | |
| • Digital Tendon Transfers | |
| • Mid-foot Reconstruction | |
| • Plantar Plate Repair | |
| Materials: | The Paratrooper™ Plantar Plate Repair System implants are |
| made from ultra-high-molecular-weight-polyethylene | |
| (UHMWPE) co-braid suture, and polyester. All suture meets all | |
| surgical suture requirements established by the USP for non- | |
| absorbable surgical sutures except for oversized diameter. The | |
| instrumentation is manufactured from medical grades of | |
| stainless steel, nitinol, and polymer. | |
| Primary | |
| Predicate: | K133671, Stryker Endoscopy ICONIX All Suture Anchor |
| System | |
| Additional | |
| Predicate: | K162429, Ziptek, LLC ZipE® Knotless Tissue Repair and |
| Attachment Device | |
| Reference Device: | K181774, Teleflex Medical Force Fiber® Sutures |
| Comparison to | |
| Predicate | |
| Indications: | The subject Paratrooper™ Plantar Plate Repair System and |
| Stryker ICONIX All Suture Anchor are intended to be used for | |
| tissue to bone fixation. The subject Paratrooper™ Plantar Plate | |
| Repair System and Ziptek ZipE® device are intended to be used | |
| for tissue to tissue fixation. All indications for the subject device | |
| are within the indications of the predicate devices. | |
| Comparison to | |
| Predicate | |
| Technological | |
| Characteristics: | The subject Paratrooper™ Plantar Plate Repair System |
| components possess the same technological characteristics as the | |
| predicate devices. These include: | |
| • performance, | |
| • basic design, | |
| • material, manufacturing and | |
| • sizes (dimensions are comparable to those offered by the | |
| predicate systems). | |
| Differences between the Paratrooper™ Plantar Plate Repair | |
| System implants and the predicate devices were shown not to | |
| raise new questions of safety and effectiveness. Therefore, the | |
| fundamental scientific technology of the subject Paratrooper™ | |
| Plantar Plate Repair System components is similar to previously | |
| cleared devices. | |
| Performance | |
| Data: | All necessary testing has been performed on representative |
| Paratrooper™ Plantar Plate Repair System components 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 pullout testing. | |
| Additional testing includes pyrogenicity, biocompatibility and | |
| sterilization. | |
| Clinical data are not needed to support the safety and | |
| effectiveness of the subject device. | |
| Conclusion: | Performance testing demonstrates the substantial equivalence of |
| the Paratrooper™ Plantar Plate Repair System to the Stryker | |
| ICONIX All Suture Anchor System and the Ziptek ZipE® | |
| Knotless Tissue Repair and Attachment Device. Therefore, the | |
| Paratrooper™ Plantar Plate Repair System is substantially | |
| equivalent to the predicate devices with respect to their | |
| indications for use, technical characteristics, and function. |
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