Arvis ® In-28000
by Kico Knee Innovation Company Pty Limited
Ref IN-28000
Arvis In-28000 is a medical device (EU MDR Class I; FDA Class II; FDA product code SBF, Orthopedic Augmented Reality; EMDN category trays) made by Kico Knee Innovation Company Pty Limited, registered in EUDAMED on 22 Oct 2026 (Basic UDI-DI 0888912000000S0104010A1RE), cleared under FDA 510(k) K243980 on 21 Mar 2025 and listed in FDA GUDID since 16 Sep 2026 (UDI-DI 00810180351805), active as of 7 Nov 2026. One FDA recall is linked to it.
Active
Valid until
No date given
FDA recalls
1 ongoingTrust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR EUDAMED | Number0888912000000S0104010A1RE 00810180351805 | Date22 Oct 2026 | StatusActive |
| United States | GUDID listing GUDID | Number00810180351805 | Date16 Sep 2026 | StatusListed |
| United States | FDA 510(k)SESE GUDID | NumberK243980 | Date21 Mar 2025 | StatusActive |
Official records
- EUDAMED public site 0888912000000S0104010A1RE
- AccessGUDID record 00810180351805
- FDA 510(k) database K243980
Across registries
- EUDAMED Basic UDI-DI 0888912000000S0104010A1RE registered 22 Oct 2026 Active
- FDA 510(k) K243980 decided 21 Mar 2025 Active
- FDA GUDID UDI-DI 00810180351805 listed 16 Sep 2026 Listed
Recalls
-
- Ongoing Z-2957-2026
Due to an internal sensor issue, image displayed with eyepiece may appear tilted relative to the eyepiece housing
Timeline
- Cleared FDA 510(k) K243980
- Recall initiated FDA recalls Z-2957-2026
- Listed FDA GUDID 00810180351805
- Registered EUDAMED 0888912000000S0104010A1RE
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- Trade name
- Arvis ®
- Generic name
- Orthopaedic prosthesis implantation positioning instrument, reusable
- Device name
- ARVIS Hip and Knee Gap Assessment Instrument Set
- Model / reference
- IN-28000
- Primary DI / UDI-DI
- 00810180351805
- Basic UDI-DI
- 0888912000000S0104010A1RE
- 510(k) Number
- FDA product code
- SBF
- EMDN code
- S010401 Trays, baskets, tubs for sterilisation and their components
- GMDN term
- Orthopaedic prosthesis implantation positioning instrument, reusable
- Device class
- Class I EUDAMEDClass II GUDID
- Regulation number
- 882.4560
- System or procedure pack
- Procedure pack
- 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
- Sterilisation method
- Moist Heat or Steam Sterilization
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Device class | Class I | Class II |
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