AETOS Shoulder System

FDA UDI

Class II (US FDA UDI)

by Smith & Nephew, Inc.

Identity

Trade Name: AETOS Shoulder System FDA UDI
Generic Name: Reverse shoulder prosthesis head FDA UDI
Device Name: 38MM GLENOSPHERE ECCENTRIC +3MM FDA UDI
Model / Reference: GLS0990-506-3803E FDA UDI
Description: 38MM GLENOSPHERE ECCENTRIC +3MM FDA UDI

Identifiers

Catalog Number: GLS0990-506-3803E FDA UDI
Primary DI / UDI-DI: 00885556871669 FDA UDI
510(k) Number: K230572 FDA UDI
FDA Product Code: KWT FDA UDI
PHX FDA UDI
HSD FDA UDI
KWS FDA UDI
GMDN Term: Reverse shoulder prosthesis head FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3650 FDA UDI
888.3660 FDA UDI
888.3690 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Reverse shoulder prosthesis head

AETOS Shoulder System by Smith & Nephew, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Reverse shoulder prosthesis head.

Equinoxe — Exactech, Inc. · Class II
Equinoxe — Exactech, Inc. · Class II
SMR System — Limacorporate · Class II
SMR Shoulder — Limacorporate · Class II
JARVIS Glenoid Rerverse Shoulder Prosthesis — FOURNITURES HOSPITALIERES INDUSTRIE · Class II
Trabecular Metal Reverse Plus™ — Zimmer, Inc. · Class II
AGILON® XO glenosphere neutral incl. screw — implantcast GmbH · Class II
TORNIER PERFORM™ REVERSED — TORNIER, INC. · Class II

Cleared under the same submission

K230572 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Smith & Nephew, Inc.

Sources (1)

FDA UDI 664641f8-8ae5-4071-bcc3-c69d3e703816 36 fields · synced Jun 8, 2026