Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in AustraliaLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 4 spellings of its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Kico Knee Innovation Company with 6 510(k) clearances, 4 device recalls and 1 AI-enabled device. The most recent is a device recall dated Jul 13, 2026: Brand Name: Kico Knee Innovation Product Name: ARVIS SURGICAL NAVIGATION SYSTEM GEN 2 ….
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Jul 13, 2026 | Brand Name: Kico Knee Innovation Product Name: ARVIS SURGICAL NAVIGATION SYSTEM GEN 2 Model/Catalog Number: IN-29200 Software Version: ARClass II · Due to an internal sensor issue, image displayed with eyepiece may appear tilted relative to the eyepiece housing | Device recalls |
| Apr 23, 2026 | Arvis Hip & Knee 3.0 Instrument Set, REF: IN-28000 containing one of the following components: IN-10500, Impactor V-Block Assembly; IN-10600Class II · The V-Block Assembly and Trackers A, B, C and E may exhibit signs of early wear and/or corrosion on the exposed magnet f | Device recalls |
| Apr 23, 2026 | Arvis Hip & Knee 2.0 Instrument Set, REF: IN-21200 containing one of the following components: IN-10500, Impactor V-Block Assembly; IN-10600Class II · The Impactor V-Block Assembly and Trackers A, B, C and E may exhibit signs of early wear and/or corrosion on the exposed | Device recalls |
| Sep 19, 2025 | Brand Name: ARVIS Product Name: ARVIS" Shoulder Model/Catalog Number: IN-27300, Arvis Surgical Planning Software Software Version: V2025.Class II · Complaint identified issue with AI surgical planning software that may result in implant malalignment and/or decrease r | Device recalls |
| Mar 21, 2025 | ARVIS Surgical Navigation SystemK243980 · SBF | 510(k) clearances |
| Jan 13, 2025 | ARVIS® ShoulderK243950 · SBF | 510(k) clearances |
| Jan 13, 2025 | ARVIS® ShoulderK243950 · Neurology | AI-enabled devices |
| Aug 8, 2024 | 360CAS KneeK242009 · OLO | 510(k) clearances |
| Jan 27, 2023 | 360CASK223927 · OLO | 510(k) clearances |
| Jan 11, 2022 | 360CASK213380 · OLO | 510(k) clearances |
| Mar 21, 2017 | 360KS Implant Positioning SystemK163405 · LLZ | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
