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510(k) K243387

GYDER® Hip System by Gyder Surgical Pty, Ltd. — Product Code OLO

K243387 is an FDA 510(k) premarket notification submitted by Gyder Surgical Pty, Ltd. for the device "GYDER® Hip System". The FDA issued a decision of Substantially Equivalent on January 29, 2025. The device falls under product code OLO (Orthopedic Stereotaxic Instrument), a Class II device regulated under 21 CFR 882.4560.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 29, 2025
Date Received
October 31, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Orthopedic Stereotaxic Instrument
Device Class
Class II
Regulation Number
882.4560
Review Panel
OR
Submission Type

Stereotaxic guidance during orthopedic surgery procedures. Indicated for Orthopedic joint or spine surgery. Neurological stereotaxic instruments are classified under product code HAW.

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  • K261060 — Navigated LLIF Impactable Tracker (May 29, 2026)
  • K254157 — CROSSNAV Navigation Enabled Instruments for Disc Preparation and Interbody (May 26, 2026)
  • K260329 — Ion-C Navigation Instruments (May 22, 2026)
  • K260582 — ROSA® Shoulder System (May 21, 2026)
  • K252880 — Pytheas Your Guided Trajectory (May 11, 2026)
  • K260011 — Foundation Surgical Navigated Lateral Disc Prep Instruments (April 16, 2026)
  • K254158 — SPINEART Navigation Instrument System (April 9, 2026)

FDA data resources