# K191227: Paratrooper Plantar Plate Repair System

- Pathway: 510(k) (Traditional)
- Applicant: Paragon 28, Inc.
- Decided: Jan 24, 2020 after 262 days
- Product code: MBI (Fastener, Fixation, Nondegradable, Soft Tissue)
- Device class: 2
- Regulation: 21 CFR 888.3040
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K961555 (1996). 36 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 38 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133671: Iconix All Suture Anchors, Stryker Corp. (2014) Summary page 4.
- K162429: ZipE Knotless Tissue Repair and Attachment Devices, Ziptek, LLC (2017) Summary page 4.

## Most influential descendants
- K211322: Paratrooper Plantar Plate Repair System (2021), 0 descendants of its own

## 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

Source page: https://510kreport.com/device/K191227
Methodology: https://510kreport.com/methodology