Manufacturer
Gyder Surgical Pty, Ltd.GYDER® Hip System
Country / Region:Australia (AU)Submission type:Traditional
Product code OLO· 21 CFR 882.4560
Product code
OLO
21 CFR 882.4560
Cited as predicate
0
Device details
FDA 510(k) registration fields
- K number
- K243387
- Device name
- GYDER® Hip System
- Company
- Gyder Surgical Pty, Ltd.
- Country / Region
- Australia(AU)
- Product code
- OLO
- Device class
- Class 2
- Regulation number
- 21 CFR 882.4560
- Date received
- 2024-10-31
- Decision date
- 2025-01-29
- Submission type
- Traditional
- Technology type
- Stereotactic Surgery(AI inferred)
- Clinical applications
- Navigation SystemOther
- Primary application
- Navigation System
- Classification source
- AI classified
Indications for 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 orthopedic surgical procedures. The GYDER® Hip Navigation System facilitates the accurate positioning of the acetabular cup relative to the alignment axes. Example orthopedic surgical procedures include: ● Total Hip Arthroplasty: Anterior The GYDER® Hip Navigation System for supine patient registration is indicated for use: ● In Hip Arthroplasty surgical procedures; ● with acetabular cups that are uncemented and allow for post-impaction measurement and confirmatory measurement.
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 orthopedic surgical procedures. The GYDER® Hip Navigation System facilitates the accurate positioning of the acetabular cup relative to the alignment axes. Example orthopedic surgical procedures include: ● Total Hip Arthroplasty: Anterior The GYDER® Hip Navigation System for supine patient registration is indicated for use: ● In Hip Arthroplasty surgical procedures; ● 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.
Summary parsed at:2026-06-19 05:16:09 UTC
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Cited as predicate
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