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510(k) K252880

Pytheas Your Guided Trajectory by Pytheas Navigation Sas — Product Code OLO

K252880 is an FDA 510(k) premarket notification submitted by Pytheas Navigation Sas for the device "Pytheas Your Guided Trajectory". The FDA issued a decision of Substantially Equivalent on May 11, 2026. 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
May 11, 2026
Date Received
September 10, 2025
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.

Other clearances for product code OLO

  • K261852 — OTS Hip (July 1, 2026)
  • K253921 — VERTICALE® Navigation Instruments (June 26, 2026)
  • K260480 — VELYS™ Robotic-Assisted Solution (June 25, 2026)
  • K260369 — Dynamis Robotic Surgical System (June 20, 2026)
  • K261665 — CORUS™ Navigation System-GN (June 18, 2026)
  • K260571 — SIMPACT Sacroiliac Joint Fixation System GX Navigation Instruments (June 2, 2026)
  • 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)

FDA data resources