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GYDER® Hip System

Gyder Surgical Pty, Ltd.

Country / Region:Australia (AU)Submission type:Traditional

Product code OLO· 21 CFR 882.4560

Summary PDF

Company

Australia (AU)

Product code

OLO
21 CFR 882.4560

Predicate devices

1

Cited as predicate

0

Device details

FDA 510(k) registration fields

K number
K243387
Device name
GYDER® Hip System
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

Predicate devices

1

K243387 references 1 predicate/reference device

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No later 510(k)s cite this device yet

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