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[ARVIS - Instruments] Registration Stylus, Hip and Knee

EUDAMEDFDA UDI

Class I (EU MDR)

Ref IN-18600Ref IN-50010Ref IN-12706Ref IN-22200Ref IN-27200Ref IN-18300

by Kico Knee Innovation Company Pty Ltd

Identity

Trade Name
Arvis EUDAMED
ARVIS ® FDA UDI
Generic Name
Orthopaedic prosthesis implantation positioning instrument, reusable FDA UDI
Surgical optical-tracking spatial marker, reusable FDA UDI
Orthopaedic stereotactic surgery system FDA UDI
Device Name
[ARVIS - Instruments] Registration Stylus, Hip and Knee EUDAMED
Glenoid Drill Guide EUDAMEDFDA UDI
Reverse Registration Tool EUDAMEDFDA UDI
ARVIS Global Shoulder Navigation System EUDAMEDFDA UDI
ARVIS Shoulder Application EUDAMED
ARVIS Shoulder Instrument Set EUDAMED
Registration Stylus FDA UDI
ARVIS Shoulder Instrument Set, Packaged FDA UDI
Model / Reference
IN-18600 EUDAMEDFDA UDI
IN-18300 EUDAMEDFDA UDI
IN-22200 EUDAMEDFDA UDI
IN-27200 EUDAMEDFDA UDI
IN-50010 EUDAMEDFDA UDI
IN-12706 EUDAMED
Description
Glenoid Drill Guide FDA UDI
Registration Stylus FDA UDI
Reverse Registration Tool FDA UDI
ARVIS Shoulder Instrument Set, Packaged FDA UDI
ARVIS Global Shoulder Navigation System FDA UDI

Identifiers

Primary DI / UDI-DI
00810180350433 EUDAMEDFDA UDI
00810180350440 EUDAMEDFDA UDI
00810180350297 EUDAMEDFDA UDI
00810180350273 EUDAMEDFDA UDI
00850012315957 EUDAMEDFDA UDI
00810180350235 EUDAMED
Basic UDI-DI
08889120000Z120114800A5G7 EUDAMED
08889120000Z12011401S01H8 EUDAMED
08889120000Z120114820B0GE EUDAMED
08889120000Z120114800B3G6 EUDAMED
08889120000Z12011480S01KR EUDAMED
088891200000000L09220B0CZ EUDAMED
Direct Marketing DI
00810180350433 EUDAMED
00810180350297 EUDAMED
00810180350440 EUDAMED
510(k) Number
K240062 FDA UDI
FDA Product Code
OLO FDA UDI
EMDN Code
Z12011480 SURGICAL NAVIGATION INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
Z12011482 SURGICAL NAVIGATION INSTRUMENTS - SOFTWARE ACCESSORIES EUDAMED
L0922 ORTHOPAEDIC SURGERY GUIDES, REUSABLE EUDAMED
GMDN Term
Orthopaedic prosthesis implantation positioning instrument, reusable FDA UDI
Surgical optical-tracking spatial marker, reusable FDA UDI
Orthopaedic stereotactic surgery system FDA UDI

Classification

Device Class
Class I EUDAMED
Class IIa EUDAMED
Class II FDA UDI
Regulation Number
882.4560 FDA UDI
Special Device Type
Software EUDAMED
Market of Registration
Italy EUDAMED
Medical Purpose
ARVIS Shoulder 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 and locating anatomical structures of the shoulder joint based on the patient's preoperative imaging. The system is intended to be used with the head mounted ARVIS® Eyepiece display for augmented reality visualization and information, such as visualization of the preoperative plan and display of instrument and implant alignment information. The augmented/ virtual displayed information should not be relied upon solely for absolute positional/alignment information and should always be used in conjunction with the displayed stereotaxic information. EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

EUDAMEDFDA UDI

Single Use

No

FDA UDI

Implantable

No

EUDAMEDFDA UDI

Reusable

Yes

EUDAMEDEUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

No

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDIFDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDIFDA UDI

Serial Number

No

FDA UDIFDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Neurological stereotactic surgery system

[ARVIS - Instruments] Registration Stylus, Hip and Knee by Kico Knee Innovation Company Pty Ltd — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID

Similar devices

Also classified as Neurological stereotactic surgery system.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/MDR

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Kico Knee Innovation Company Pty Ltd
EUDAMED SRN
AU-MF-000011477
Authorised Representative
MedEnvoy Global BV NL-AR-000024028

Sources (11)

  • EUDAMED 032b6246-70b7-414f-bfd3-dc7ba8ba28a7 61 fields · synced Aug 4, 2026
  • FDA UDI a475bb86-7d9c-4c15-9d91-7f0a567bc26b 34 fields · synced May 29, 2026
  • FDA UDI 971e7542-2f3f-403a-821b-03da949871d8 33 fields · synced May 30, 2026
  • FDA UDI c02bf310-6c69-45af-9a83-2826dc18450b 34 fields · synced May 30, 2026
  • FDA UDI 45dceea3-a0ae-4150-b59f-72297ac9e86e 33 fields · synced May 30, 2026
  • FDA UDI 792a3548-f82c-4ab5-a085-c716d33ce113 33 fields · synced May 30, 2026
  • EUDAMED 42cfddcc-0cd4-4134-9800-11d45b3f8137 61 fields · synced Jul 11, 2026
  • EUDAMED d5c08b29-1a51-4694-899b-9c56367aea0a 61 fields · synced Jul 15, 2026
  • EUDAMED af3ca837-900f-47a4-b776-5a6bb87fe672 61 fields · synced Jul 17, 2026
  • EUDAMED 12fec66e-619c-48fb-958f-0772347f2e42 61 fields · synced Jul 29, 2026
  • EUDAMED c19a9bd1-9bae-46c3-b5e0-f02bed7bddf8 61 fields · synced Aug 2, 2026