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510(k) Data Aggregation
K Number
K183690Device Name
Tenodesis Screw System
Manufacturer
Paragon 28,Inc.
Date Cleared
2019-03-01
(60 days)
Product Code
MBI
Regulation Number
888.3040Why did this record match?
Applicant Name (Manufacturer) :
Paragon 28,Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended 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.
Device Description
The Tenodesis Screw System is composed of a screw manufactured from polyetheretherketone (PEEK). They are fully threaded, cannulated anchors with a flat head. The screws are provided in multiple lengths and sizes to accommodate variations in patient anatomy.
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