MDR EZ Pass and Precision Flexible Reamer

Completed

Conditions studied: Anterior Cruciate Ligament Injury, Rotator Cuff Tear

In brief

The objective of this study is to confirm the safety and performance on the EZPass Suture Passer Instrumentation and the Precision Flexible Reamer Instrumentation.

Key facts

Study ID

NCT03914703

Run by

Zimmer Biomet

People needed

73

Starts

2019-08-08

Expected to finish

2024-04-08

Last updated by the study team

2025-07-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• EZ Pass Suture Passer:
• Intended as an open or arthroscopic instrument utilized in conjunction with a nitinol wire or nylon monofilament to aid in passing suture through soft tissue.
• Precision Flexible Reamer:
• This device is a hand held, or hand-manipulated device, intended to be used in ACL and PCL reconstruction surgeries and is intended for medical purposes to manipulate tissue, or for use with other devices in these surgeries.

You may not qualify if…

• EZ Pass Suture Passer:
• Any use other than the approved uses indicated in the Instructions for Use (IFU).
• Precision Flexible Reamer:
• Any use other than the approved uses indicated in the Instructions for Use (IFU).

Where it is running

• OrthoCarolina — Charlotte, North Carolina, United States

Full record on ClinicalTrials.gov

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