Tornier HRS Max

Primary DI
00840338603531
Brand
Tornier HRS Max
Company
TORNIER, INC.
Model
ARS1040618
Catalog number
ARS1040618
Device description
Stem
Published
2025-11-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
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

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K251686000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K251686000Tornier Humeral Reconstruction System Max (Tornier HRS Max)Tornier, Inc.2025-10-30KWT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840338603531PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840338603531008403386035318403386035310840338603531

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
Outer Diameter18Millimeter

Contacts#

Phone, Email table
PhoneEmail
+1(888)494-7950customerservice@tornier.com

Regulatory Flags#

DUNS number
968990812
Device count
1
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00846832085675TORNIER PERFORM™ REVERSEDDWJ1017304DWJ10173042022-01-05
00846832085682TORNIER PERFORM™ REVERSEDDWJ1017305DWJ10173052022-01-05
00846832085699TORNIER PERFORM™ REVERSEDDWJ1017306DWJ10173062022-01-05
00846832085705TORNIER PERFORM™ REVERSEDDWJ1017307DWJ10173072022-01-05
00846832085743TORNIER PERFORM™ REVERSEDDWJ1017204DWJ10172042022-01-05
00846832085750TORNIER PERFORM™ REVERSEDDWJ1017205DWJ10172052022-01-05
00846832085767TORNIER PERFORM™ REVERSEDDWJ1017206DWJ10172062022-01-05
00846832085774TORNIER PERFORM™ REVERSEDDWJ1017207DWJ10172072022-01-05
00846832085781TORNIER PERFORM™ REVERSEDDWJ1017701DWJ10177012022-01-05
00846832085798TORNIER PERFORM™ REVERSEDDWJ1017702DWJ10177022022-01-05
00846832085804TORNIER PERFORM™ REVERSEDDWJ1017703DWJ10177032022-01-05
00846832085811TORNIER PERFORM™ REVERSEDDWJ1017601DWJ10176012022-01-05
00846832085828TORNIER PERFORM™ REVERSEDDWJ1017602DWJ10176022022-01-05
00846832085835TORNIER PERFORM™ REVERSEDDWJ1017603DWJ10176032022-01-05
00846832092086Tornier Perform® Reversed Augmented GlenoidDWJ513DWJ5132022-05-10
00846832092093Tornier Perform® Reversed Augmented GlenoidDWJ503DWJ5032022-05-10
00846832092109Tornier Perform® Reversed Augmented GlenoidDWJ505DWJ5052022-05-10
00846832092123Tornier Perform® Reversed Augmented GlenoidDWJ502DWJ5022022-05-10
00846832092130Tornier Perform® Reversed Augmented GlenoidDWJ514DWJ5142022-05-10
00846832092147Tornier Perform® Reversed Augmented GlenoidDWJ515DWJ5152022-05-10

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