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Arvis ® In-28000

by Kico Knee Innovation Company Pty Limited

Arvis ® In-28000 is a Class II device made by Kico Knee Innovation Company Pty Limited, cleared under FDA 510(k) K243980 on 21 Mar 2025 and listed in FDA GUDID since 17 Nov 2025 (UDI-DI 00810180350020), active as of 22 Oct 2026. One FDA recall is linked to it.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

1 ongoing

This device is named in the recall

Documents

510(k) K243980

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00810180350020 UDI-DI Date17 Nov 2025ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Special NumberK243980 Date21 Mar 2025DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K243980 decided 21 Mar 2025 Active
  • FDA GUDID UDI-DI 00810180350020 listed 17 Nov 2025 Listed

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-2957-2026 FDA Class II initiated 13 Jul 2026

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

Timeline

3 dated events

  1. Cleared FDA 510(k) K243980
  2. Listed FDA GUDID 00810180350020
  3. Recall initiated FDA recalls Z-2957-2026

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Arvis ®
Generic name
Orthopaedic prosthesis implantation positioning instrument, reusable
Model / reference
IN-28000
Primary DI / UDI-DI
00810180350020
510(k) Number
FDA product code
SBF
GMDN term
Orthopaedic prosthesis implantation positioning instrument, reusable
Device class
Class II
Regulation number
882.4560
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Cleared under the same submission (K243980)

and 8 more cleared under K243980

Other devices from Kico Knee Innovation Company Pty Limited

See all devices from Kico Knee Innovation Company Pty Limited →

Properties

  • Sterilise before use
  • Prescription use
  • Convenience kit
  • Serial number
Other properties (11, all answered No)