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Arvis

by Kico Knee Innovation Company Pty Ltd

Ref IN-50000

Arvis (IN-50000) is a device classified as Class IIa in the EU and Class II in the US made by Kico Knee Innovation Company Pty Limited, registered in EUDAMED on 2 Sep 2025 (Basic UDI-DI 08889120000Z12011401S00H6) and listed in FDA GUDID since 19 May 2025 (UDI-DI 00850012315940), active as of 25 Oct 2026.

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number08889120000Z12011401S00H6 Basic UDI-DI 00850012315940UDI-DIDate2 Sep 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number00850012315940 UDI-DI Date19 May 2025ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 08889120000Z12011401S00H6 registered 2 Sep 2025 Active
  • FDA GUDID UDI-DI 00850012315940 listed 19 May 2025 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00850012315940
  2. Registered EUDAMED 08889120000Z12011401S00H6

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Generic name
Orthopaedic stereotactic surgery system
Device name
ARVIS Global Hip & Knee Navigation System
Model / reference
IN-50000
Primary DI / UDI-DI
00850012315940
Basic UDI-DI
08889120000Z12011401S00H6
FDA product code
OLO
EMDN code
Z12011401 Surgical navigation system
GMDN term
Orthopaedic stereotactic surgery system
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
882.4560
System or procedure pack
System
EU registration type
System or procedure pack
Medical purpose
The ARVIS system is indicated for assisting the surgeon in the positioning and alignment of implants relative to reference alignment axes and landmarks in stereotactic orthopedic surgery. The system aids the surgeon in making intraoperative measurements such as changes in leg length in Hip Arthroplasty. The system is compatible with straight acetabular impactors and with specific offset impactors, identified in the instructions for use, for which an adapter has been validated.
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class II

Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Manufacturer details

EUDAMED SRN
AU-PR-000041381

Similar devices in this category

Other devices filed under SURGICAL NAVIGATION SYSTEM.

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Properties

  • Prescription use
  • Convenience kit
  • Serial number
Other properties (12, all answered No)