# K211002: Grappler Suture Anchor System

- Pathway: 510(k) (Traditional)
- Applicant: Paragon 28, Inc.
- Decided: Jul 7, 2021 after 96 days
- Product code: MBI (Fastener, Fixation, Nondegradable, Soft Tissue)
- Device class: 2
- Regulation: 21 CFR 888.3040
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K971358 (1997). 54 ancestors in all.
6 later devices descend from it; 6 cite it directly.
0 of 61 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102298: Transtend BR Anchor W/ Orthocord, Transtend TI Anchor W/Orthocord, Transtend Peek Anchor W/Orthocord, Healix Transtend, Depuy Mitek, A Johnson & Johnson Company (2011) Summary page 5.

## Most influential descendants
- K222091: Grappler Suture Anchor System (2022), 3 descendants of its own
- 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
- K262047: Grappler Suture Anchor System (2026), 0 descendants of its own
- K253886: Grappler Suture Anchor PCFD Tether System (2026), 0 descendants of its own

## Recalls of this device
- Jul 13, 2022 · Class II · Z-1776-2022: Suture anchor may break upon insertion, which could lead to potential debris in patient, and delays in surgery.

## 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, Chrisman-Snook Repair), Ankle Ligament Repair, Medial Stabilization (Deltoid Repair, Spring Ligament Reconstruction), 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

Source page: https://510kreport.com/device/K211002
Methodology: https://510kreport.com/methodology