FDA.reportPublic FDA data

Titan Modular Shoulder System 2.5

Primary DI
00885556837719
Brand
Titan Modular Shoulder System 2.5
Company
Smith & Nephew, Inc.
Model
STEM-0950-025-06
Catalog number
STEM-0950-025-06
Device description
TSS CEMENTED STEM SZ. 06
Published
2022-12-22
Public version status
Update
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

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HSDProsthesis, Shoulder, Hemi-, Humeral, Metallic UncementedOrthopedic2
KWSProsthesis, Shoulder, Semi-Constrained, Metal/Polymer CementedOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K100448000
K112438000
K142413000
K213827000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K100448000ASCENSION MODULAR TOTAL SHOULDER SYSTEMAscension Orthopedics, Inc.2010-08-30KWS
K112438000TITAN MODULAR TOTAL SHOULDER SYSTEMAscension Orthopedic2012-04-11KWS
K142413000TITAN Modular Total Shoulder SystemAscension Orthopedics2014-11-14KWS
K213827000TITAN Total Shoulder System (TSS), TITAN Reverse Shoulder System (RSS), TITAN Humeral Resurfacing Arthroplasty System (HRA), Modular Radial Head System (MRH), Katalyst Bipolar Radial Head System (Katalyst)Smith & Nephew, Inc.2022-03-11KWS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00885556837719PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00885556837719008855568377198855568377190885556837719

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.

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
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
07630542795602Anatomic Shoulder ProsthesisMedacta International SAKWS2026-09-28
07630542795817Anatomic Shoulder ProsthesisMedacta International SAKWS2026-09-28
07630542795824Anatomic Shoulder ProsthesisMedacta International SAKWS2026-09-28
07630542795831Anatomic Shoulder ProsthesisMedacta International SAKWS2026-09-28
07630542795848Anatomic Shoulder ProsthesisMedacta International SAKWS2026-09-28
07630542795855Anatomic Shoulder ProsthesisMedacta International SAKWS2026-09-28
07630542795879Anatomic Shoulder ProsthesisMedacta International SAKWS2026-09-28
03701037320440FX V135 Shoulder ProsthesisFX SOLUTIONSHSD2026-09-22
03701037321188ORTHOPEDIC MANUAL SURGICAL INSTRUMENTFX SOLUTIONSHSD2026-09-22
00840097533919Veritas HemiarthroplastyRestor3d, Inc.HSD2026-09-18
00840097533926Veritas HemiarthroplastyRestor3d, Inc.HSD2026-09-18
00840097533933Veritas HemiarthroplastyRestor3d, Inc.HSD2026-09-18
00840097533940Veritas HemiarthroplastyRestor3d, Inc.HSD2026-09-18
00840097533957Veritas HemiarthroplastyRestor3d, Inc.HSD2026-09-18
00889024707047Signature ONE Software PackageOrthosoft IncKWS2026-07-10
00889024707047Signature ONE Software PackageOrthosoft IncHSD2026-07-10
00887868554391Signature™ Comprehensive®Orthosoft IncHSD2024-02-09
00887868554391Signature™ Comprehensive®Orthosoft IncKWS2024-02-09
00887868554407Signature™ Comprehensive®Orthosoft IncHSD2024-02-09
00887868554407Signature™ Comprehensive®Orthosoft IncKWS2024-02-09
00885556810613AETOS Shoulder SystemSmith & Nephew, Inc.HSD2023-02-13
00885556810613AETOS Shoulder SystemSmith & Nephew, Inc.KWS2023-02-13
00885556810057AETOS Shoulder SystemSmith & Nephew, Inc.HSD2023-02-08
00885556810057AETOS Shoulder SystemSmith & Nephew, Inc.KWS2023-02-08
00885556810064AETOS Shoulder SystemSmith & Nephew, Inc.HSD2023-02-08
00885556810064AETOS Shoulder SystemSmith & Nephew, Inc.KWS2023-02-08
00885556810071AETOS Shoulder SystemSmith & Nephew, Inc.KWS2023-02-08
00885556810071AETOS Shoulder SystemSmith & Nephew, Inc.HSD2023-02-08
00885556810125AETOS Shoulder SystemSmith & Nephew, Inc.KWS2023-02-08
00885556810125AETOS Shoulder SystemSmith & Nephew, Inc.HSD2023-02-08