# K211322: Paratrooper Plantar Plate Repair System

- Pathway: 510(k) (Traditional)
- Applicant: Paragon 28, Inc.
- Decided: Aug 30, 2021 after 122 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: 10 generations back to K961555 (1996). 37 ancestors in all.
No later device cites it as a predicate yet.
0 of 38 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K191227: Paratrooper Plantar Plate Repair System, Paragon 28, Inc. (2020) Summary page 4.

## 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/K211322
Methodology: https://510kreport.com/methodology