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brAIn Shoulder Positioning

FDA UDI

Class II (US FDA UDI)

by Avatar Medical

Identity

Trade Name
brAIn Shoulder Positioning FDA UDI
Generic Name
Orthopaedic/craniofacial implantation planning software FDA UDI
Device Name
The brAIn Shoulder Positioning (BSP) software is a cloud-based application intended for shoulder surgeons. It is used to plan anatomic and reverse total shoulder replacement surgeries using FX Shoulder Solutions implants. The software is accessible via a web-based interface, where the user is prompted to upload their patient's information accompanied with their shoulder CT-scan (DICOM series) in a dedicated interface. The software automatically segments (using machine learning) and performs measurements on the scapula and humerus anatomy contained in the DICOM series. These segmentations are used for planning, which includes a live 3D viewer that allows for soft tissue visualization. Implants for the glenoid and humerus are positioned using this same 3D interface through a dedicated 3D manipulation gizmo. The changes in shoulder anatomy resultant from the implants are relayed in a post-position interface that displays information related to distalization and lateralization. The software outputs a planning mul FDA UDI
Model / Reference
BSP001 FDA UDI
Description
The brAIn Shoulder Positioning (BSP) software is a cloud-based application intended for shoulder surgeons. It is used to plan anatomic and reverse total shoulder replacement surgeries using FX Shoulder Solutions implants. The software is accessible via a web-based interface, where the user is prompted to upload their patient's information accompanied with their shoulder CT-scan (DICOM series) in a dedicated interface. The software automatically segments (using machine learning) and performs measurements on the scapula and humerus anatomy contained in the DICOM series. These segmentations are used for planning, which includes a live 3D viewer that allows for soft tissue visualization. Implants for the glenoid and humerus are positioned using this same 3D interface through a dedicated 3D manipulation gizmo. The changes in shoulder anatomy resultant from the implants are relayed in a post-position interface that displays information related to distalization and lateralization. The software outputs a planning mul FDA UDI

Identifiers

Primary DI / UDI-DI
03770026095034 FDA UDI
FDA Product Code
QIH FDA UDI
LLZ FDA UDI
GMDN Term
Orthopaedic/craniofacial implantation planning software FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
892.2050 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Orthopaedic/craniofacial implantation planning software

brAIn Shoulder Positioning by Avatar Medical — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Orthopaedic/craniofacial implantation planning software.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Avatar Medical

Sources (1)

  • FDA UDI 3b4e9f75-f717-4c62-b739-d71e10270538 33 fields · synced May 30, 2026