FDA.reportPublic FDA data

AETOS Shoulder System

Primary DI
00885556919354
Brand
AETOS Shoulder System
Company
Smith & Nephew, Inc.
Model
COM-0990-808-00
Catalog number
COM-0990-808-00
Device description
STEM COMPACTOR SIZE 0
Published
2025-11-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
K252416000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K252416000AETOS Shoulder System Meta Humeral Prosthesis Size 0Smith & Nephew, Inc.2025-10-29KWS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00885556919354PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00885556919354008855569193548855569193540885556919354

GMDN Terms#

Term, Definition table
TermDefinition
Humeral stem prosthesis trial, reusableA copy of a final humeral stem prosthesis designed to be used before primary or revision implant surgery to validate the proper size of the permanent prosthesis required by the patient and to ensure its proper orientation and positioning. It is typically made of metal and/or synthetic polymer. This is a reusable device intended to be sterilized prior to use.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

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

Regulatory Flags#

DUNS number
045483575
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00885556925379CORIOGRAPHROB20032ROB200322026-07-08
00885556925386CORIOGRAPHROB20031ROB200312026-07-08
00885556904879EVOS70887105708871052026-06-25
00885556904923EVOS70897130708971302026-06-25
00885556906163EVOS70879090708790902026-06-25
00885556906170EVOS70879095708790952026-06-25
00885556906187EVOS70879100708791002026-06-25
00885556906194EVOS70879105708791052026-06-25
00885556906200EVOS70879110708791102026-06-25
00885556906217EVOS70879115708791152026-06-25
00885556906224EVOS70879120708791202026-06-25
00885556906231EVOS70879125708791252026-06-25
00885556906248EVOS70879130708791302026-06-25
00885556906255EVOS70879135708791352026-06-25
00885556906262EVOS70879140708791402026-06-25
00885556906279EVOS70879145708791452026-06-25
00885556906286EVOS70879150708791502026-06-25
00885556906293EVOS70879155708791552026-06-25
00885556906309EVOS70879160708791602026-06-25
00885556906316EVOS70879165708791652026-06-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
03701037313855ORTHOPEDIC MANUAL SURGICAL INSTRUMENTFX SOLUTIONSHSD2026-06-26
03701037313855ORTHOPEDIC MANUAL SURGICAL INSTRUMENTFX SOLUTIONSPHX2026-06-26
03701037315897ORTHOPEDIC MANUAL SURGICAL INSTRUMENTFX SOLUTIONSHSD2026-06-26
03701037315897ORTHOPEDIC MANUAL SURGICAL INSTRUMENTFX SOLUTIONSKWT2026-06-26
03701037315897ORTHOPEDIC MANUAL SURGICAL INSTRUMENTFX SOLUTIONSPHX2026-06-26
03701037315903ORTHOPEDIC MANUAL SURGICAL INSTRUMENTFX SOLUTIONSKWT2026-06-26
03701037315903ORTHOPEDIC MANUAL SURGICAL INSTRUMENTFX SOLUTIONSHSD2026-06-26
03701037315903ORTHOPEDIC MANUAL SURGICAL INSTRUMENTFX SOLUTIONSPHX2026-06-26
03701037315910ORTHOPEDIC MANUAL SURGICAL INSTRUMENTFX SOLUTIONSHSD2026-06-26
03701037315910ORTHOPEDIC MANUAL SURGICAL INSTRUMENTFX SOLUTIONSKWT2026-06-26
03701037315910ORTHOPEDIC MANUAL SURGICAL INSTRUMENTFX SOLUTIONSPHX2026-06-26
03701037315927ORTHOPEDIC MANUAL SURGICAL INSTRUMENTFX SOLUTIONSHSD2026-06-26
03701037315927ORTHOPEDIC MANUAL SURGICAL INSTRUMENTFX SOLUTIONSKWT2026-06-26
03701037315927ORTHOPEDIC MANUAL SURGICAL INSTRUMENTFX SOLUTIONSPHX2026-06-26
03701037315934ORTHOPEDIC MANUAL SURGICAL INSTRUMENTFX SOLUTIONSHSD2026-06-26
03701037315934ORTHOPEDIC MANUAL SURGICAL INSTRUMENTFX SOLUTIONSKWT2026-06-26
03701037315934ORTHOPEDIC MANUAL SURGICAL INSTRUMENTFX SOLUTIONSPHX2026-06-26
03701037315941ORTHOPEDIC MANUAL SURGICAL INSTRUMENTFX SOLUTIONSHSD2026-06-26
03701037315941ORTHOPEDIC MANUAL SURGICAL INSTRUMENTFX SOLUTIONSKWT2026-06-26
03701037315941ORTHOPEDIC MANUAL SURGICAL INSTRUMENTFX SOLUTIONSPHX2026-06-26
03701037315958ORTHOPEDIC MANUAL SURGICAL INSTRUMENTFX SOLUTIONSKWT2026-06-26
03701037315958ORTHOPEDIC MANUAL SURGICAL INSTRUMENTFX SOLUTIONSHSD2026-06-26
03701037315958ORTHOPEDIC MANUAL SURGICAL INSTRUMENTFX SOLUTIONSPHX2026-06-26
03701037315965ORTHOPEDIC MANUAL SURGICAL INSTRUMENTFX SOLUTIONSHSD2026-06-26
03701037315965ORTHOPEDIC MANUAL SURGICAL INSTRUMENTFX SOLUTIONSKWT2026-06-26
03701037315965ORTHOPEDIC MANUAL SURGICAL INSTRUMENTFX SOLUTIONSPHX2026-06-26
03701037315972ORTHOPEDIC MANUAL SURGICAL INSTRUMENTFX SOLUTIONSHSD2026-06-26
03701037315972ORTHOPEDIC MANUAL SURGICAL INSTRUMENTFX SOLUTIONSKWT2026-06-26
03701037315972ORTHOPEDIC MANUAL SURGICAL INSTRUMENTFX SOLUTIONSPHX2026-06-26
03701037315989ORTHOPEDIC MANUAL SURGICAL INSTRUMENTFX SOLUTIONSHSD2026-06-26