FX Shoulder Solutions Retrospective / Prospective Clinical Study
Start Date
12/6/2022
Completion Date
12/30/2032
Summary
Subjects implanted with the shoulder replacement medical devices manufactured by FX Shoulder Solutions and distributed by FX Shoulder Solutions.
Detailed Description
To evaluate patient outcomes following shoulder replacement with FX Shoulder Solutions medical devices To demonstrate effectiveness, safety and survivorship of FX Shoulder Solutions medical devices To provide data and analysis to FX Shoulder Solutions to meet regulatory requirements. To provide data and analysis for presentations, abstracts, publications and other public release of results. Clinical data in the Investigator's clinic notes and patient files regarding demographics, baseline medical and shoulder status, surgical procedure and implant components, and any completed postoperative clinical data will be collected retrospectively as data for the Study following signed patient consent and enrollment into the study. Each patient will be evaluated prospectively, and clinical data collected at the first baseline clinical evaluation using the protocol specified evaluations following study enrollment with successive postoperative evaluations in accordance with the postoperative intervals.
Eligibility Criteria
Age Range: No minimum to No maximum
Interventions
FX Artificial Shoulder Prosthesis
Conditions
Locations
OrthoArizona
Gilbert, Arizona 85297
United States
Advanced Orthopedics Institute
The Villages, Florida 32159
United States