# K200428: Multi-Drive Interference Screw System

- Pathway: 510(k) (Traditional)
- Applicant: Nvision Biomedical Technologies, Inc.
- Decided: Nov 10, 2020 after 263 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: 8 generations back to K961555 (1996). 34 ancestors in all.
No later device cites it as a predicate yet.
0 of 35 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 6.
- K180573: Responsive Arthroscopy Interference Screw System, Responsive Arthroscopy, LLC (2018) Summary page 6.
- K170877: Parcus SLiK Fix Screw, Parcus Medical (2017) Summary page 6.

## Indications for use
The Multi-Drive 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, 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/K200428
Methodology: https://510kreport.com/methodology