510(k) Report

FDA applicant

Kico Knee Innovation Company Pty Limited

Frenchs Forest, AU6 decisions2017–20252 recalls

FDA records 6 decisions for Kico Knee Innovation Company Pty Limited (Frenchs Forest, AU) from 2017 to 2025: 6 510(k) clearances. Most are in product codes OLO (Orthopedic Stereotaxic Instrument) and SBF (Orthopedic Augmented Reality). Since 2016 its 510(k)s took a median of 59 days from receipt to decision, against 90 for FDA’s reviews in the same codes and years. Its devices cite 7 predicates, 2 of them its own earlier devices. 2 recalls are linked to its devices.

FDA’s records also spell it “Kico Knee Innovation Company Pty, Ltd.”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, neurology panel, where it files most

How often FDA has decided Kico Knee Innovation Company Pty Limited’s devices, and how often a recall has named them.

FDA decisions per year

2in 2025

2017: 12022: 12023: 12024: 12025: 2
2017high 2 (2025) · low 0 (2018)2026

2026 so far, outlined.

Recalls per year

1in 2026

2025: 12026 (partial year): 1
2017high 1 (2025) · low 0 (2017)2026

Class I Class II/III not classified

FIG. 1 — Kico Knee Innovation Company Pty Limited by year, 2017–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Kico Knee Innovation Company Pty Limited’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • OLOOrthopedic Stereotaxic Instrument3decisions
  • SBFOrthopedic Augmented Reality2decisions
  • LLZSystem, Image Processing, Radiological1decision

How long do its 510(k) reviews take?

Since 2016, its 6 510(k)s took a median of 59 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 90 days; 5 of its 6 were faster than that.

Whose devices does it build on?

Its devices cite 7 predicates; 2 are its own earlier devices. The firms it cites most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K223927360CASKico Knee Innovation Company Pty Limited · 20231cites it
  • K213380360CASKico Knee Innovation Company Pty Limited · 20221cites it

What has FDA decided for it lately?

  • K243980ARVIS Surgical Navigation SystemKico Knee Innovation Company Pty Limited · 20251 recall
  • K243950ARVIS® ShoulderKico Knee Innovation Company Pty, Ltd. · 20252 recalls
  • K242009360CAS KneeKico Knee Innovation Company Pty, Ltd. · 2024
  • K223927360CASKico Knee Innovation Company Pty Limited · 2023
  • K213380360CASKico Knee Innovation Company Pty Limited · 2022
  • K163405360KS Implant Positioning SystemKico Knee Innovation Company Pty Limited · 2017

All 4 as Kico Knee Innovation Company Pty Limited →All 2 as Kico Knee Innovation Company Pty, Ltd. →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K243950Brand Name: Kico Knee Innovation Product Name: ARVIS SURGICAL NAVIGATION SYSTEM GEN 2…Jul 13, 2026Class II
  • K243950Brand Name: ARVIS Product Name: ARVIS" Shoulder Model/Catalog Number: IN-27300, Arvis…Sep 19, 2025Class II