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510(k) K252989

“POINT” Kinguide Agile Hybrid Navigation System; DRF Accessories Set by Point Robotics MedTech, Inc. — Product Code OLO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 20, 2026
Date Received
September 18, 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 by Point Robotics MedTech, Inc.

  • K252755 — POINT Kinguide Agile Robotic Arm Surgical Stereotactic System (January 23, 2026)
  • K241130 — “POINT” Kinguide Agile Hybrid Navigation System (PSHF01-000) (July 24, 2024)
  • K230087 — “POINT” Kinguide Agile Hybrid Navigation System (July 17, 2023)
  • K220241 — “POINT” Kinguide Robotic-Assisted Surgical System (August 9, 2022)

Other clearances for product code OLO

  • K260010 — TMINI® Miniature Robotic System (March 3, 2026)
  • K260222 — Mako Total Knee Application (February 25, 2026)
  • K253623 — Spine Guidance 5.4 Software; Spine Guidance 5.4 Upgrade; Spine Guidance 5.4 Upda (February 19, 2026)
  • K252597 — Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For U (February 19, 2026)
  • K254148 — VERTICALE GPS Instruments (February 19, 2026)
  • K253381 — Stealth AXiS™ Surgical System with Stealth AXiS™ Spine clinical application (February 12, 2026)
  • K252873 — Q Interbody Instruments (February 6, 2026)
  • K252058 — ROSA Knee System with UltraSound Imaging Platform (USIP) (February 6, 2026)
  • K252871 — Spine Guidance 5.3 Software; Q Interbody Instruments; Elite Q Attachments; Elite (February 6, 2026)
  • K252087 — Navigation Module of the Cortium® System (February 3, 2026)