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Arvis ® In-28050

by Kico Knee Innovation Company Pty Limited

Ref IN-28050

Arvis ® In-28050 is a device classified as Class I 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 08889120000Z120114800A4G5), cleared under FDA 510(k) K243980 on 21 Mar 2025 and listed in FDA GUDID since 17 Nov 2025 (UDI-DI 00810180351782), active as of 7 Nov 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

1 ongoing

Recall on shared 510(k) K243980; other models may be affected

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K243980

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number00810180351782 UDI-DI Date17 Nov 2025ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number08889120000Z120114800A4G5 Basic UDI-DI 00810180351782UDI-DIDate2 Sep 2025RegisteredStatusActive
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Special NumberK243980 Date21 Mar 2025DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 08889120000Z120114800A4G5 registered 2 Sep 2025 Active
  • FDA 510(k) K243980 decided 21 Mar 2025 Active
  • FDA GUDID UDI-DI 00810180351782 listed 17 Nov 2025 Listed

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-2957-2026 FDA Class II initiated 13 Jul 2026 on shared 510(k) K243980

    Due to an internal sensor issue, image displayed with eyepiece may appear tilted relative to the eyepiece housing

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Timeline

4 dated events

  1. Cleared FDA 510(k) K243980
  2. Registered EUDAMED 08889120000Z120114800A4G5
  3. Listed FDA GUDID 00810180351782
  4. Recall initiated FDA recalls Z-2957-2026

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
Arvis ®
Generic name
Optical surgical tracking system spatial marker, reusable
Device name
[ARVIS - Instruments] Tracker A, B, C
Model / reference
IN-28050
Primary DI / UDI-DI
00810180351782 EUDAMED
00810180350051 GUDID
Basic UDI-DI
08889120000Z120114800A4G5
Direct marketing DI
00810180351782
510(k) Number
FDA product code
OLO
EMDN code
Z12011480 Surgical navigation instruments - hardware accessories
GMDN term
Optical surgical tracking system spatial marker, reusable
Device class
Class I EUDAMED
Class II GUDID
Regulation number
882.4560
EU registration type
Standard device
EU market of registration
Italy
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
00810180351782
GUDID
00810180350051
Device classEUDAMED
Class I
GUDID
Class II

The registries describe this device under different primary UDI-DIs (EUDAMED lists 00810180351782; FDA GUDID lists 00810180350051), so their flags are not compared. Device class is stated on each registry's own scale: Class I in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Cleared under the same submission (K243980)

and 8 more cleared under K243980

Similar devices in this category

Other devices filed under SURGICAL NAVIGATION INSTRUMENTS - HARDWARE ACCESSORIES.

Other devices from Kico Knee Innovation Company Pty Limited

See all devices from Kico Knee Innovation Company Pty Limited →

Properties

  • Sterilise before use
  • Reusable
  • Prescription use
  • Lot / batch number
Other properties (21, all answered No)