(122 days)
No
The device description and performance studies focus on mechanical and usability testing of a physical implant, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes.
The device is intended for the fixation of tissue, including various repairs and reconstructions in the foot and ankle, which are therapeutic interventions.
No
This device is described as a "Plantar Plate Repair System" intended for "fixation of tissue to tissue to tissue" in surgical repairs. Its function is to perform a therapeutic procedure (repair tissue), not to diagnose a condition.
No
The device description explicitly states it includes an "all-suture soft tissue fixation device" which is a physical implant, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Description: The Paratrooper™ Plantar Plate Repair System is described as an "all-suture soft tissue fixation device" used for "fixation of tissue to tissue to tissue." This is a surgical implant used directly on the patient's body during a procedure.
- Intended Use: The intended use is for surgical repair and stabilization of ligaments and tendons in the foot and ankle. This is a therapeutic and structural function, not a diagnostic one based on analyzing specimens.
The information provided clearly indicates this is a surgical device, not a device used for laboratory testing of biological samples.
N/A
Intended Use / Indications for 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
Product codes
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 or preloaded on an inserter.
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
Not Found
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 mechanical performance testing and usability testing. Bacterial endotoxin testing was also conducted and the device was found to meet the established limits.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Paratrooper™ Plantar Plate Repair System (K191227)
Reference Device(s)
ICONIX All Suture Anchor System (K133671)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
0
August 30, 2021
Image /page/0/Picture/1 description: The image contains 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.
Paragon 28, Inc. Haylie Hertz Regulatory Affairs Specialist 14445 Grasslands Dr. Englewood, Colorado 80112
Re: K211322
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: July 29, 2021 Received: August 3, 2021
Dear Haylie Hertz:
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 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
1
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 mediation-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,
Laura C. Rose, Ph.D. 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
2
Indications for Use
510(k) Number (if known) K211322
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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3
510(k) Summary
| 510(k) Number: | K211322 |
|---|---|
| Device Trade Name: | Paratrooper™ Plantar Plate Repair System |
| Manufacturer: | Paragon 28, Inc. |
| 14445 Grasslands Dr. | |
| Englewood, CO 80112 | |
| Contact: | Haylie Hertz |
| Phone: 303-720-0017 | |
| hhertz@paragon28.com | |
| Date Prepared: | August 30, 2021 |
| Common Name: | Soft Tissue and Bone Fixation Fastener |
| Classification: | 21 CFR 888.3040 |
| Class: | II |
| Product Code: | MBI |
| Predicate Device: | Paratrooper™ Plantar Plate Repair System (K191227) |
| Reference Device: | ICONIX All Suture Anchor System (K133671) |
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 ●
4
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 or preloaded on an inserter.
Substantial Equivalence:
The intended use of the modified device, as described in its labeling, has not changed as a result of the modifications proposed in the present submission. In addition, the subject device possesses the same technological characteristics as the predicate device, including performance, basic design, material, sterilization and sizes. Differences between the Paratrooper™ Plantar Plate Repair System and the predicate device (implantation technique, anchor interconnection, dyes, and manufacturing) were shown not to raise new questions of safety and effectiveness. Therefore, the Paratrooper™ Plantar Plate Repair System is substantially equivalent to the predicate device cited on the previous page with respect to indications, design, function, and performance.
Performance Testing:
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 mechanical performance testing and usability testing. Bacterial endotoxin testing was also conducted and the device was found to meet the established limits.
Clinical Testing:
Clinical testing was not necessary to support equivalence.
Conclusion:
The Paratrooper™ Plantar Plate Repair System possesses the same intended use and technological characteristics as the predicate device. Therefore, the Paratrooper™ Plantar Plate Repair System is substantially equivalent for its intended use.