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510(k) K242009

360CAS Knee by Kico Knee Innovation Company Pty, Ltd. — Product Code OLO

K242009 is an FDA 510(k) premarket notification submitted by Kico Knee Innovation Company Pty, Ltd. for the device "360CAS Knee". The FDA issued a decision of Substantially Equivalent on August 8, 2024. The device falls under product code OLO (Orthopedic Stereotaxic Instrument), a Class II device regulated under 21 CFR 882.4560. Kico Knee Innovation Company Pty, Ltd. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 8, 2024
Date Received
July 10, 2024
Clearance Type
Special
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 Kico Knee Innovation Company Pty, Ltd.

  • K243950 — ARVIS® Shoulder (January 13, 2025)

Other clearances for product code OLO

  • K262506 — Remex Spine Surgery Navigation - Universal Instruments (August 20, 2026)
  • K261410 — Navbit MARQ (PRD-001-SUP (Supine Registration Kit), PRD-001-LAT (Lateral Registr (July 30, 2026)
  • K261205 — SPINEART Navigation Instrument System (July 29, 2026)
  • K261024 — TMINI Miniature Robotic System (July 24, 2026)
  • K262121 — Ion-L Navigated Instruments (July 24, 2026)
  • K261113 — Op.n™ Spine Navigation and Robotic Guidance (July 22, 2026)
  • 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)

FDA data resources