510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K243980Substantially Equivalent

ARVIS Surgical Navigation System

Kico Knee Innovation Company, Frenchs Forest, AU / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K243980 is the FDA 510(k) clearance record for ARVIS Surgical Navigation System, a class II device, cleared for Kico Knee Innovation Company Pty Limited on under FDA product code SBF (Orthopedic Augmented Reality). FDA's definition for product code SBF reads: "An orthopedic augmented reality device provides visual guidance during orthopedic procedures, where the use of stereotaxic navigation is utilized. Visual guidance is displayed as “augmented reality” stereoscopic images to intraoperatively...". FDA records list 6 510(k) clearances for Kico Knee Innovation Company Pty Limited, from to . As of , FDA records show one recall naming K243980.

Clearance record

Decision date
Received
(88 days to decision)
Product code
SBF Orthopedic Augmented Reality
Regulation
21 CFR 882.4560
Device class
Class II
Review panel
Neurology
Applicant
Kico Knee Innovation Company Pty Limited Unit 1, 25 Frenchs Forest Rd. E, Frenchs Forest, AU
510(k) summary
Summary PDF
Third party review
No

Clearances, product code SBF

Trailing 12 months
3 clearances under product code SBF in the twelve months to October 2026, January 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code SBF, trailing twelve months
MonthClearances
November 20250
December 20250
January 20261
February 20260
March 20260
April 20261
May 20260
June 20260
July 20261
August 20260
September 20260
October 20260