# K222091: Grappler Suture Anchor System

- Pathway: 510(k) (Traditional)
- Applicant: Paragon 28, Inc.
- Decided: Sep 14, 2022 after 61 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: 11 generations back to K971358 (1997). 55 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 59 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K211002: Grappler Suture Anchor System, Paragon 28, Inc. (2021) 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 Grappler Suture Anchor System is intended for the fixation of soft tissue to bone including: Elbow: Biceps Tendon Reattachment, Lateral Epicondylitis Repair, Tennis Elbow Repair Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Repair Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Ligament Reconstruction, TFCC Foot/Ankle: Lateral Stabilization (Brostrom, Brostrom-Gould, Christman-Snook Repair), Ankle Ligament Repair, Medial Stabilization (Deltoid, Spring Ligament Repair), Achilles Tendon Repair, Metatarsal Ligament Repair, Syndesmosis Repair, Hallux Valgus Reconstruction, Digital Tendon Transfers, Mid-foot Reconstruction, LisFranc Repair Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis, Extra Capsular Reconstruction, Patellar Ligament and Tendon Avulsion Repair Hip: Capsular Repair, Acetabular Labral Repair The plate interacting anchors are only indicated for the above Hand/Wrist and Foot/Ankle indications.

Source page: https://510kreport.com/device/K222091
Methodology: https://510kreport.com/methodology