# K253886: Grappler Suture Anchor PCFD Tether System

- Pathway: 510(k) (Traditional)
- Applicant: Paragon 28, Inc.
- Decided: Mar 17, 2026 after 103 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: 14 generations back to K971358 (1997). 123 ancestors in all.
No later device cites it as a predicate yet.
0 of 124 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K240594: Grappler Suture Anchor R3FLEX IOL System, Paragon 28, Inc. (2024) Summary page 6.
- K241864: Grappler Interference Screw System, Paragon 28, Inc. (2024) Summary page 6.
- K211002: Grappler Suture Anchor System, Paragon 28, Inc. (2021) Summary page 6.

## Indications for use
The Grappler Suture Anchor PCFD Tether System is intended for the fixation of soft tissue to bone including: Foot/Ankle: Medial Stabilization (Deltoid and Spring Ligament Repair for addressing Progressive Collapsing Foot Deformity), Hindfoot Repair (Correction of Peritalar Subluxation/Dislocation, Hindfoot Valgus Deformity or Subfibular Impingement for Addressing Progressive Collapsing Foot Deformity), Interosseous Talocalcaneal Ligament Repair to address Progressive Collapsing Flatfoot Deformity

Source page: https://510kreport.com/device/K253886
Methodology: https://510kreport.com/methodology