# K211770: R3ACT Stabilization System

- Pathway: 510(k) (Traditional)
- Applicant: Paragon 28, Inc.
- Decided: Dec 25, 2021 after 200 days
- Product code: HWC (Screw, Fixation, Bone)
- 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 K904436 (1990). 66 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 70 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K173550: Akros FibuLink™ Syndesmosis Repair Kit, Akros Medical (2017) Summary page 5.
- K203511: Baby Gorilla/Gorilla Plating System, Paragon 28, Inc. (2020) Summary page 5.
- K041189: Arthrex Trimit Family, Arthrex, Inc. (2004) Summary page 5.
- K130033: Toggleloc Xtender; Toggleloc XL; Implant Kit Toggleloc; Implant Kit Toggleloc BTB, Extended Toggleloc; Toggleloc; BTB to, Biomet Manufacturing Corp (2013) Summary page 5.

## Most influential descendants
- K223589: Grappler Suture Anchor R3FLEX IOL System (2023), 2 descendants of its own
- K240594: Grappler Suture Anchor R3FLEX IOL System (2024), 1 descendant of its own
- K253886: Grappler Suture Anchor PCFD Tether System (2026), 0 descendants of its own

## Indications for use
The R3ACT™ Stabilization System is intended as an adjunct in fracture repair and ligamentous injuries of small bones of the feet and ankles including the distal tibia, distal fibula, talus, and calcaneus, and as an adjunct in external and intramedullary fixation systems involving plates and rods. Specifically, the R3ACT™ Stabilization System is intended to provide fixation during the healing process following a syndesmotic trauma, such as fixation of syndesmosis (syndesmosis disruptions) in connection with Weber B and C ankle fractures.

Source page: https://510kreport.com/device/K211770
Methodology: https://510kreport.com/methodology