Paratrooper Plantar Plate Repair System

K191227 · Paragon 28, Inc. · MBI · Jan 24, 2020 · Orthopedic

Device Facts

• Record ID: K191227
• Device Name: Paratrooper Plantar Plate Repair System
• Applicant: Paragon 28, Inc.
• Product Code: MBI · Orthopedic
• Decision Date: Jan 24, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

Paratrooper™ Plantar Plate Repair System; all-suture soft tissue fixation device; consists of suture implant attached to needle; used by surgeons in clinical settings for orthopedic foot/ankle repairs; device facilitates tissue-to-bone or tissue-to-tissue fixation; provides mechanical stabilization of ligaments and tendons; benefits patient through secure anatomical repair; device is manual; no electronic or software components.

Clinical Evidence

Bench testing only. Performance characterized via pullout testing. Additional testing includes biocompatibility, pyrogenicity, and sterilization. No clinical data required.

Technological Characteristics

Implants made of UHMWPE co-braid suture and polyester; suture meets USP requirements for non-absorbable surgical sutures (except diameter). Instrumentation manufactured from medical-grade stainless steel, nitinol, and polymer. Manual fixation device; no energy source or software.

Indications for Use

Indicated for fixation of tissue to bone and tissue to tissue in foot/ankle procedures including lateral/medial stabilization, Achilles tendon repair, metatarsal ligament/tendon repair, hallux valgus reconstruction, digital tendon transfers, mid-foot reconstruction, and plantar plate repair.

Regulatory Classification

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

• Stryker Endoscopy ICONIX All Suture Anchor System (K133671)
• Ziptek, LLC ZipE® Knotless Tissue Repair and Attachment Device (K162429)

Reference Devices

• Teleflex Medical Force Fiber® Sutures (K181774)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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.<br>14445 Grasslands Dr.<br>Englewood, Colorado 80112<br>Phone: [phone]<br>Fax: [phone] |
| Sponsor contact: | Eric Lintula, Senior Director of Quality and Regulatory Affairs |
| Trade Name: | Paratrooper™ Plantar Plate Repair System |
| Regulatory Class: | Class II |
| Regulation,<br>Product Code,<br>Classification, and<br>Common Name: | 888.3040, MBI, Fastener, Fixation, Nondegradable, Soft Tissue |
| Device<br>Description: | The Paratrooper™ Plantar Plate Repair System includes an all-<br>suture soft tissue fixation device. The suture implant comes in<br>one size and is provided attached to a needle. |
| Indications for<br>Use: | The Paratrooper™ Plantar Plate Repair System is intended for<br>fixation of tissue to bone and tissue to tissue. Specific<br>indications:<br>Foot/ankle:<br>• Lateral Stabilization<br>• Medial Stabilization<br>• Achilles Tendon Repair<br>• Metatarsal Ligament and Tendon Repair<br>• Hallux Valgus Reconstruction<br>• Digital Tendon Transfers<br>• Mid-foot Reconstruction<br>• Plantar Plate Repair |
| Materials: | The Paratrooper™ Plantar Plate Repair System implants are<br>made from ultra-high-molecular-weight-polyethylene<br>(UHMWPE) co-braid suture, and polyester. All suture meets all<br>surgical suture requirements established by the USP for non-<br>absorbable surgical sutures except for oversized diameter. The<br>instrumentation is manufactured from medical grades of<br>stainless steel, nitinol, and polymer. |
| Primary<br>Predicate: | K133671, Stryker Endoscopy ICONIX All Suture Anchor<br>System |
| Additional<br>Predicate: | K162429, Ziptek, LLC ZipE® Knotless Tissue Repair and<br>Attachment Device |
| Reference Device: | K181774, Teleflex Medical Force Fiber® Sutures |
| Comparison to<br>Predicate<br>Indications: | The subject Paratrooper™ Plantar Plate Repair System and<br>Stryker ICONIX All Suture Anchor are intended to be used for<br>tissue to bone fixation. The subject Paratrooper™ Plantar Plate<br>Repair System and Ziptek ZipE® device are intended to be used<br>for tissue to tissue fixation. All indications for the subject device<br>are within the indications of the predicate devices. |
| Comparison to<br>Predicate<br>Technological<br>Characteristics: | The subject Paratrooper™ Plantar Plate Repair System<br>components possess the same technological characteristics as the<br>predicate devices. These include:<br>• performance,<br>• basic design,<br>• material, manufacturing and<br>• sizes (dimensions are comparable to those offered by the<br>predicate systems).<br>Differences between the Paratrooper™ Plantar Plate Repair<br>System implants and the predicate devices were shown not to<br>raise new questions of safety and effectiveness. Therefore, the<br>fundamental scientific technology of the subject Paratrooper™<br>Plantar Plate Repair System components is similar to previously<br>cleared devices. |
| Performance<br>Data: | All necessary testing has been performed on representative<br>Paratrooper™ Plantar Plate Repair System components to assure<br>substantial equivalence to its predicate and demonstrate the<br>subject device performs as intended. All testing was performed<br>on finished devices.<br>The device performance was characterized via pullout testing.<br>Additional testing includes pyrogenicity, biocompatibility and<br>sterilization.<br>Clinical data are not needed to support the safety and<br>effectiveness of the subject device. |
| Conclusion: | Performance testing demonstrates the substantial equivalence of<br>the Paratrooper™ Plantar Plate Repair System to the Stryker<br>ICONIX All Suture Anchor System and the Ziptek ZipE®<br>Knotless Tissue Repair and Attachment Device. Therefore, the<br>Paratrooper™ Plantar Plate Repair System is substantially<br>equivalent to the predicate devices with respect to their<br>indications for use, technical characteristics, and function. |

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