# K183690: Tenodesis Screw System

- Pathway: 510(k) (Traditional)
- Applicant: Paragon 28, Inc.
- Decided: Mar 1, 2019 after 60 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: 1 generation back to K051726 (2005). 1 ancestor in all.
3 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051726: Arthrex Tenodesis Family, Arthrex, Inc. (2005) Summary page 6.

## Most influential descendants
- K241864: Grappler Interference Screw System (2024), 1 descendant of its own
- K253886: Grappler Suture Anchor PCFD Tether System (2026), 0 descendants of its own
- K200428: Multi-Drive Interference Screw System (2020), 0 descendants of its own

## Indications for use
The Tenodesis 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 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 Illiotibial 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/K183690
Methodology: https://510kreport.com/methodology