Arvis ® In-29103
by Kico Knee Innovation Company Pty Limited
Ref IN-29103
Arvis ® In-29103 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 21 Oct 2026 (Basic UDI-DI 08889120000Z120114800G0GF), cleared under FDA 510(k) K243980 on 21 Mar 2025 and listed in FDA GUDID since 16 Sep 2026 (UDI-DI 00810180351744), 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 | Number08889120000Z120114800G0GF 00810180351744 | Date21 Oct 2026 | StatusActive |
| United States | GUDID listing GUDID | Number00810180351744 | Date16 Sep 2026 | StatusListed |
| United States | FDA 510(k)SESE GUDID | NumberK243980 | Date21 Mar 2025 | StatusActive |
Official records
- EUDAMED public site 08889120000Z120114800G0GF
- AccessGUDID record 00810180351744
- FDA 510(k) database K243980
Across registries
- EUDAMED Basic UDI-DI 08889120000Z120114800G0GF registered 21 Oct 2026 Active
- FDA 510(k) K243980 decided 21 Mar 2025 Active
- FDA GUDID UDI-DI 00810180351744 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 00810180351744
- Registered EUDAMED 08889120000Z120114800G0GF
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- Withdrawn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 Instrument - SS8 Mount Kit
- Model / reference
- IN-29103
- Primary DI / UDI-DI
- 00810180351744
- Basic UDI-DI
- 08889120000Z120114800G0GF
- Direct marketing DI
- 00810180351744
- 510(k) Number
- FDA product code
- SBF
- EMDN code
- Z12011480 Surgical navigation instruments - hardware accessories
- GMDN term
- Orthopaedic prosthesis implantation positioning instrument, reusable
- Device class
- Class I EUDAMEDClass 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
| Field | EUDAMED | GUDID |
|---|---|---|
| Device class | Class I | Class II |
| Sterilise before use | No | Yes |
Registry differences
EUDAMED and FDA GUDID describe the same product (same UDI-DI) and state different values:
- Sterilise before use UDI-DI 00810180351744: EUDAMED states No, FDA GUDID states Yes.
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.
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