FDA.reportPublic FDA data

AETOS Shoulder System

Primary DI
00885556919378
Brand
AETOS Shoulder System
Company
Smith & Nephew, Inc.
Model
BRH-0990-898-0
Catalog number
BRH-0990-898-0
Device description
CRUCIATE BROACH 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
00885556919378PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00885556919378008855569193788855569193780885556919378

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic broachA surgical instrument that is designed as an elongated, tapered and serrated cutting tool intended for shaping and enlarging holes in bone tissue. This is a reusable device.

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
03596010482280CLEAR-TRAC721012172101212015-10-22
03596010532619NA721071972107192015-08-30
03596010505132SCULPTOR721069772106972015-08-30
03596010505149SCULPTOR721069672106962015-08-30
03596010505170SCULPTOR721069572106952015-08-30
03596010505194SCULPTOR721070072107002015-08-30
00885554016703560P72202351722023512015-08-29
00885556919781Real IntelligenceROB30007ROB300072026-10-13
00885556924327Real IntelligenceROB30801ROB308012026-10-08
03596010445803NA720903072090302015-08-30
03596010470294SAPHYRE720968472096842015-08-30
03596010470331ABLATOR720965972096592015-08-30
03596010470348ABLATOR720965872096582015-08-30
03596010470416ABLATOR720965172096512015-08-30
03596010470577ABLATOR720965072096502015-08-30
03596010470614TAC-S720963272096322015-08-30
03596010448446TWINFIX720910972091092015-08-30
03596010470393ABLATOR720965372096532015-08-30
03596010470423ABLATOR720964972096492015-08-30
03596010510976NA721004072100402015-08-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840097503677Veritas InstrumentationRestor3d, Inc.PHX2026-10-16
07630699705950Shoulder SystemMedacta International SAPHX2026-10-01
07630699705967Shoulder SystemMedacta International SAPHX2026-10-01
07630699705974Shoulder SystemMedacta International SAPHX2026-10-01
07630699705998Shoulder SystemMedacta International SAPHX2026-10-01
07630699706001Shoulder SystemMedacta International SAPHX2026-10-01
07630699706018Shoulder SystemMedacta International SAPHX2026-10-01
07630699706032Shoulder SystemMedacta International SAPHX2026-10-01
07630699706049Shoulder SystemMedacta International SAPHX2026-10-01
07630699706056Shoulder SystemMedacta International SAPHX2026-10-01
B1132R2HC300100Shoulder Innovations RSA Glenosphere Trial Instrument CaseShoulder Innovations, Inc.PHX2026-09-30
07630345775320Shoulder SystemMedacta International SAPHX2026-09-28
07630345775375Shoulder SystemMedacta International SAPHX2026-09-28
07630542727528Shoulder SystemMedacta International SAPHX2026-09-28
07630542727535Shoulder SystemMedacta International SAPHX2026-09-28
07630542727542Shoulder SystemMedacta International SAPHX2026-09-28
00889024707047Signature ONE Software PackageOrthosoft IncKWT2026-07-10
00889024707047Signature ONE Software PackageOrthosoft IncPHX2026-07-10
00889024707047Signature ONE Software PackageOrthosoft IncKWS2026-07-10
00889024707047Signature ONE Software PackageOrthosoft IncHSD2026-07-10
00887868554391Signature™ Comprehensive®Orthosoft IncPHX2024-02-09
00887868554391Signature™ Comprehensive®Orthosoft IncKWS2024-02-09
00887868554391Signature™ Comprehensive®Orthosoft IncHSD2024-02-09
00887868554391Signature™ Comprehensive®Orthosoft IncKWT2024-02-09
00887868554407Signature™ Comprehensive®Orthosoft IncKWS2024-02-09
00887868554407Signature™ Comprehensive®Orthosoft IncHSD2024-02-09
00887868554407Signature™ Comprehensive®Orthosoft IncPHX2024-02-09
00887868554407Signature™ Comprehensive®Orthosoft IncKWT2024-02-09
00887868522987Signature ONEOrthosoft IncHSD2022-07-20
00887868522987Signature ONEOrthosoft IncKWS2022-07-20