FDA.reportPublic FDA data

AETOS Shoulder System

Primary DI
00885556910139
Brand
AETOS Shoulder System
Company
Smith & Nephew, Inc.
Model
STEM-0990-101-003
Catalog number
STEM-0990-101-003
Device description
STEMLESS HUMERAL STEM SIZE 3 L
Published
2025-11-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HSDPROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED
KWSPROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
KWTPROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED
PHXshoulder prosthesis, reverse configuration
PKCProsthesis, total anatomic shoulder, uncemented metaphyseal humeral stem with no diaphyseal incursion, semi-constrained

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HSDProsthesis, Shoulder, Hemi-, Humeral, Metallic UncementedOrthopedic2
KWSProsthesis, Shoulder, Semi-Constrained, Metal/Polymer CementedOrthopedic2
KWTProsthesis, Shoulder, Non-Constrained, Metal/Polymer CementedOrthopedic2
PHXShoulder Prosthesis, Reverse ConfigurationOrthopedic2
PKCProsthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-ConstrainedOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K240716000
K252129000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K240716000AETOS Shoulder System Stemless Humeral ProsthesisSmith & Nephew, Inc.2024-11-20PKC
K252129000AETOS Shoulder System Stemless Humeral ProsthesisSmith & Nephew, Inc.2025-10-03PKC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00885556910139PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00885556910139008855569101398855569101390885556910139

GMDN Terms#

Term, Definition table
TermDefinition
Coated shoulder humeral stem prosthesisA sterile implantable device designed to provide fixation within the proximal humerus and a site of attachment for a humeral head or humeral body prosthesis as part of a shoulder joint replacement. The device is made of metal [e.g., titanium (Ti), cobalt-chrome (Co-Cr), stainless steel] and is coated with a material (e.g., porous materials, hydroxyapatite) intended to improve fixation and stability by promoting bone ingrowth. Fixation devices for implantation (e.g., screws) may be included and implantation may be performed with or without bone cement.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)238-7538GUDID@SMITH-NEPHEW.COM

Regulatory Flags#

DUNS number
045483575
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00885556819845Uni-CP Compression Plate286322ND286322ND2023-11-07
00885556819852Uni-CP Compression Plate286324ND286324ND2023-11-07
00885556819869Uni-CP Compression Plate286326ND286326ND2023-11-07
00885556819876Uni-CP Compression Plate286328ND286328ND2023-11-07
00885556819883Uni-CP Compression Plate286330ND286330ND2023-11-07
00885556819890Uni-CP Compression Plate286332ND286332ND2023-11-07
00885556819906Uni-CP Compression Plate286334ND286334ND2023-11-07
00885556819357General Instruments219865ND219865ND2023-10-27
00885556846599Total Wrist Fusion186200ND186200ND2023-10-27
00885556910245UNI-CP Compression Plate186300ND186300ND2023-10-27
00885556819722Total Wrist Fusion286220ND286220ND2023-10-26
00885556819746Total Wrist Fusion286222ND286222ND2023-10-26
00885556819760Total Wrist Fusion286224ND286224ND2023-10-26
00885556819807UNI-CP Compression Plate286314ND286314ND2023-10-26
00885556819814UNI-CP Compression Plate286316ND286316ND2023-10-26
00885556819821UNI-CP Compression Plate286318ND286318ND2023-10-26
00885556819838UNI-CP Compression Plate286320ND286320ND2023-10-26
00885556847329UNI-CP Compression Plate219535ND219535ND2023-10-26
00885556819623Total Wrist Fusion286210ND286210ND2023-10-25
00885556819647SURFIXTotal Wrist Fusion286212ND286212ND2023-10-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840097533919Veritas HemiarthroplastyRestor3d, Inc.HSD2026-09-18
00840097533919Veritas HemiarthroplastyRestor3d, Inc.PHX2026-09-18
00840097533926Veritas HemiarthroplastyRestor3d, Inc.PHX2026-09-18
00840097533926Veritas HemiarthroplastyRestor3d, Inc.HSD2026-09-18
00840097533933Veritas HemiarthroplastyRestor3d, Inc.PHX2026-09-18
00840097533933Veritas HemiarthroplastyRestor3d, Inc.HSD2026-09-18
00840097533940Veritas HemiarthroplastyRestor3d, Inc.PHX2026-09-18
00840097533940Veritas HemiarthroplastyRestor3d, Inc.HSD2026-09-18
00840097533957Veritas HemiarthroplastyRestor3d, Inc.PHX2026-09-18
00840097533957Veritas HemiarthroplastyRestor3d, Inc.HSD2026-09-18
00840097533964Veritas HemiarthroplastyRestor3d, Inc.PHX2026-09-18
00840097533964Veritas HemiarthroplastyRestor3d, Inc.HSD2026-09-18
00840097533971Veritas HemiarthroplastyRestor3d, Inc.PHX2026-09-18
00840097533971Veritas HemiarthroplastyRestor3d, Inc.HSD2026-09-18
00840097533988Veritas HemiarthroplastyRestor3d, Inc.HSD2026-09-18
00840097533988Veritas HemiarthroplastyRestor3d, Inc.PHX2026-09-18
00840097533995Veritas HemiarthroplastyRestor3d, Inc.PHX2026-09-18
00840097533995Veritas HemiarthroplastyRestor3d, Inc.HSD2026-09-18
00840097534008Veritas HemiarthroplastyRestor3d, Inc.PHX2026-09-18
00840097534008Veritas HemiarthroplastyRestor3d, Inc.HSD2026-09-18
00840097534015Veritas HemiarthroplastyRestor3d, Inc.PHX2026-09-18
00840097534015Veritas HemiarthroplastyRestor3d, Inc.HSD2026-09-18
00840097534022Veritas HemiarthroplastyRestor3d, Inc.PHX2026-09-18
00840097534022Veritas HemiarthroplastyRestor3d, Inc.HSD2026-09-18
B1132N2GI200050Shoulder Innovations InSet GOShoulder Innovations, Inc.KWS2026-09-18
B1132N2GI200050Shoulder Innovations InSet GOShoulder Innovations, Inc.KWT2026-09-18
B1132N2GI200100Shoulder Innovations InSet GOShoulder Innovations, Inc.KWS2026-09-18
B1132N2GI200100Shoulder Innovations InSet GOShoulder Innovations, Inc.KWT2026-09-18
B1132N2GI206000Shoulder Innovations InSet GOShoulder Innovations, Inc.KWT2026-09-18
B1132N2GI206000Shoulder Innovations InSet GOShoulder Innovations, Inc.KWS2026-09-18