# Arvis ® In-28000

> Active: European Union and United States. Medical device record on deviCERTS, compiled from public registries.

- Canonical page: <https://devicerts.com/devices/arvis-r-in-28000>
- Manufacturer: [Kico Knee Innovation Company Pty Limited](https://devicerts.com/manufacturers/kico-knee-innovation-company-pty-limited) (Australia)
- Name in the registry: ARVIS ® IN-28000
- Device class: Class I (EU MDR); Class II (US FDA)
- FDA product code: SBF
- EMDN: S010401 TRAYS, BASKETS, TUBS FOR STERILISATION AND THEIR COMPONENTS
- GMDN: Orthopaedic prosthesis implantation positioning instrument, reusable (13180)

## Registrations and authorizations

- **EUDAMED** · CE/MDR · European Union · Basic UDI-DI 0888912000000S0104010A1RE · UDI-DI 00810180351805 · registered 2026-10-22 · status: Active
- **GUDID** · GUDID listing · United States · UDI-DI 00810180351805 · listed 2026-09-16 · status: Listed (GUDID: in commercial distribution)
- **GUDID** · FDA 510(k) · United States · K243980 · decision 2025-03-21 · decision SESE · status: Active · from GUDID

## Recalls

- Z-2957-2026 · Class II · ongoing · initiated 2026-07-13: Due to an internal sensor issue, image displayed with eyepiece may appear tilted relative to the eyepiece housing

## Identity

- Trade name: ARVIS ® [FDA GUDID (AccessGUDID)]
- Generic name: Orthopaedic prosthesis implantation positioning instrument, reusable [FDA GUDID (AccessGUDID)]
- Device name: ARVIS Hip and Knee Gap Assessment Instrument Set [EUDAMED]
- Model / reference: IN-28000 [EUDAMED, FDA GUDID (AccessGUDID)]

## Identifiers

- Primary DI / UDI-DI: 00810180351805 [EUDAMED, FDA GUDID (AccessGUDID)]
- Basic UDI-DI: 0888912000000S0104010A1RE [EUDAMED]
- 510(k) Number: K243980 [FDA GUDID (AccessGUDID)]
- FDA product code: SBF [FDA GUDID (AccessGUDID)]
- EMDN code: S010401 [EUDAMED]
- GMDN term: Orthopaedic prosthesis implantation positioning instrument, reusable (13180) [FDA GUDID (AccessGUDID)]

## Classification

- Device class: Class I [EUDAMED]; Class II [FDA GUDID (AccessGUDID)]
- Regulation number: 882.4560 [FDA GUDID (AccessGUDID)]
- System or procedure pack: Procedure pack [EUDAMED]
- EU registration type: System or procedure pack [EUDAMED]
- 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. [EUDAMED]
- GUDID distribution status: In Commercial Distribution [FDA GUDID (AccessGUDID)]

## Clinical & Handling

- Sterilisation method: Moist Heat or Steam Sterilization [FDA GUDID (AccessGUDID)]

## Properties

- Sterilise before use: Yes [EUDAMED, FDA GUDID (AccessGUDID)]
- Prescription use: Yes [FDA GUDID (AccessGUDID)]
- Convenience kit: Yes [FDA GUDID (AccessGUDID)]
- Serial number: Yes [FDA GUDID (AccessGUDID)]
- Supplied sterile: No [EUDAMED, FDA GUDID (AccessGUDID)]
- Single use: No [FDA GUDID (AccessGUDID)]
- Implantable: No [FDA GUDID (AccessGUDID)]
- Contains latex: No [FDA GUDID (AccessGUDID)]
- Over-the-counter: No [FDA GUDID (AccessGUDID)]
- Combination product: No [FDA GUDID (AccessGUDID)]
- HCT/P: No [FDA GUDID (AccessGUDID)]
- Premarket exempt: No [FDA GUDID (AccessGUDID)]
- Lot / batch number: No [FDA GUDID (AccessGUDID)]
- Expiration date: No [FDA GUDID (AccessGUDID)]
- Manufacturing date: No [FDA GUDID (AccessGUDID)]

## Source and citation

- Cite as: Arvis ® In-28000, Kico Knee Innovation Company Pty Limited. deviCERTS medical device catalogue. https://devicerts.com/devices/arvis-r-in-28000 (data as of 2026-11-15).
- Data sources: [FDA GUDID (AccessGUDID)](https://accessgudid.nlm.nih.gov/), [EUDAMED](https://ec.europa.eu/tools/eudamed), [FDA recalls](https://open.fda.gov/apis/device/recall/)
- Registry records last synced: 2026-11-07
- Statuses computed as of: 2026-11-15
- JSON: <https://devicerts.com/devices/arvis-r-in-28000.json>
- Licence: [CC BY 4.0](https://creativecommons.org/licenses/by/4.0/). The deviCERTS layout and text are licensed under CC BY 4.0. Registry data remain under their source terms: U.S. FDA data (openFDA, AccessGUDID) are U.S. public domain; EUDAMED data are subject to the European Commission reuse terms.
- Attribution: DevicErts, https://devicerts.com/devices/arvis-r-in-28000
- Compiled by deviCERTS (devicerts.com) from public medical device registries (EUDAMED, European Commission; U.S. FDA via openFDA; AccessGUDID, U.S. National Library of Medicine). deviCERTS is not an official register and gives no regulatory advice: the record in the registry itself prevails.