# K243387: GYDER® Hip System

- Pathway: 510(k) (Traditional)
- Applicant: Gyder Surgical Pty, Ltd.
- Decided: Jan 29, 2025 after 90 days
- Product code: OLO (Orthopedic Stereotaxic Instrument)
- Device class: 2
- Regulation: 21 CFR 882.4560
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K983831 (1999). 24 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K130387: Orthoalign Plus System, Orthalign, Inc. (2013) Summary page 5.

## Most influential descendants
- K253507: Packaged Assembly, Reusable Navigation Unit; Lantern ASC, Smart Pack kit, Knee (2026), 0 descendants of its own

## 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 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.

Source page: https://510kreport.com/device/K243387
Methodology: https://510kreport.com/methodology