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K Number
K243387Device Name
GYDER® Hip System
Manufacturer
Date Cleared
2025-01-29
(90 days)
Product Code
Regulation Number
882.4560Why did this record match?
Applicant Name (Manufacturer) :
Gyder Surgical Pty Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The GYDER® Hip Navigation System is a computer-controlled system intended to assist the surgeon in determining reference alignment axes in relation to anatomical structures during stereotactic orthopaedic surgical procedures. The GYDER® Hip Navigation System facilitates the accurate positioning of the acetabular cup only during Anterior Hip Arthroplasty approaches with the patients in supine position.
The GYDER® Hip Navigation System is intended to be used only during Anterior Hip Arthroplasty approaches with the patients in supine position, with acetabular cups that are uncemented and allow for post-impaction measurement and confirmatory measurement.
Device Description
The GYDER® Hip System is a computer controlled non-invasive surgical tool to aid navigation during Total Hip Arthroplasty via the Anterior Approach. The system includes both reusable and consumable components, designed to work together to assist the surgeon in positioning the acetabular cup in the intended orientation during primary or revision Total Hip Arthroplasty.
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