# K241864: Grappler Interference Screw System

- Pathway: 510(k) (Special)
- Applicant: Paragon 28, Inc.
- Decided: Jul 25, 2024 after 28 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: 2 generations back to K051726 (2005). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K183690: Tenodesis Screw System, Paragon 28, Inc. (2019) Summary page 7.

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

## Indications for use
The Grappler Interference Screw System is intended for soft tissue reattachment, i.e. fixation of ligament and tendon graft tissue and tendon transfers in surgeries of the shoulder, elbow, knee, foot/ankle, and hand/wrist. Specifically: Shoulder: » Rotator Cuff Repairs » Bankart Repair * SLAP Lesion Repair * Biceps Tenodesis » Acromio-Clavicular Separation Repair * Deltoid Repair » Capsular Shift or Capsulolabral Reconstruction. Foot/Ankle: * Lateral Stabilization * Medial Stabilization * Achilles Tendon Repair » Hallux Valgus Reconstruction » Midfoot Reconstruction (e.g. reconstruction of the Spring Ligament to address Progressive Collapsing Flatfoot Deformity) * Hindfoot Reconstruction (e.g. reconstruction of the Interosseous Talocalcaneal Ligament and/or Spring Ligament to address Progressive Collapsing Flatfoot Deformity) » Metatarsal Ligament Repair * Flexor Hallucis Longus Transfer for Achilles Tendon Reconstruction, and * Flexor Digitorum Longus Transfer for Posterior Tibial Tendon Reconstruction. Knee: * Anterior Cruciate Ligament Repair * Medial Collateral Ligament Repair » Lateral Collateral Ligament Repair * Patellar Tendon Repair * Posterior Oblique Ligament Repair * llliotibial Band Tenodesis Elbow: * Biceps Tendon Reattachment * Ulnar or Radial Collateral Ligament Reconstruction Hand/Wrist: » Scapholunate Ligament Reconstruction » Ulnar Collateral Ligament Reconstruction » Radial Collateral Ligament Reconstruction » Carpometacarpal joint arthroplasty (basal thumb joint arthroplasty) Carpal Ligament Reconstructions and repairs » Ligament Reconstruction and Tendon Interposition.

Source page: https://510kreport.com/device/K241864
Methodology: https://510kreport.com/methodology