FDA.reportPublic FDA data

Blueprint

Primary DI
03700434023114
Brand
Blueprint
Company
TORNIER
Model
BPUE001
Catalog number
4.1.Win
Device description
WIN
Published
2024-03-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
KWSPROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
PHXshoulder prosthesis, reverse configuration
QHEShoulder arthroplasty implantation system

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWSProsthesis, Shoulder, Semi-Constrained, Metal/Polymer CementedOrthopedic2
PHXShoulder Prosthesis, Reverse ConfigurationOrthopedic2
QHEShoulder Arthroplasty Implantation SystemOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K232265000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K232265000BLUEPRINT™ Patient Specific InstrumentationTornier S.A.S.2024-02-21PHX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03700434023114PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03700434023114037004340231143700434023114

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic CAD/CAM systemAn assembly of software-based devices designed for automated computer-aided design (CAD) and computer-aided manufacturing (CAM) of custom-made (specifically prescribed to each patient's needs) orthopaedic implants typically involving the prescription forming (milling) of the femoral stem of a hip replacement for optimal fitting to that patient's bone anatomy. It typically includes three-dimensional (3-D) image acquisition and viewing capabilities that provide values (measurements) for the production phase, software for record collection, treatment planning, simulation and device production, and robotic capabilities for production of the prosthesis to be fitted to the patient.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+330476613500order@tornier.com

Regulatory Flags#

DUNS number
260324876
Device count
1

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03700386968303Aequalis FractureMWA302MWA3022022-08-08
03700386915260AEQUALISDWB1512015-10-16
03700386916144AEQUALIS REVERSEDDWB9352015-10-16
03700386916151AEQUALIS REVERSEDDWB9362015-10-16
03700386916618AEQUALIS REVERSEDDWD0022015-10-16
03700386916731AEQUALIS REVERSEDDWD0692015-10-16
03700386931529AEQUALIS REVERSED ADAPTERDWD8632015-10-16
03700386931536AEQUALIS REVERSED ADAPTERDWD8642015-10-16
03700386931543AEQUALIS REVERSED ADAPTERDWD8652015-10-16
03700386925726BLUEPRINT™ PATIENT SPECIFIC INSTRUMENTATIONMWJ0212017-04-03
03700386955648BLUEPRINT™ PATIENT SPECIFIC INSTRUMENTATIONMWJ0032016-09-11
03700386955655BLUEPRINT™ PATIENT SPECIFIC INSTRUMENTATIONMWJ0042017-04-03
03700386915062AEQUALIS GLENOIDDWB0012016-01-28
03700386915079AEQUALIS GLENOIDDWB0022015-10-16
03700386915086AEQUALIS GLENOIDDWB0032015-10-16
03700386915093AEQUALIS GLENOIDDWB0052015-10-16
03700386915109AEQUALIS GLENOIDDWB0062015-10-16
03700386915413AEQUALIS GLENOIDDWB2102015-10-16
03700386915420AEQUALIS GLENOIDDWB2112015-10-16
03700386915437AEQUALIS GLENOIDDWB2122015-10-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
03701037313855ORTHOPEDIC MANUAL SURGICAL INSTRUMENTFX SOLUTIONSPHX2026-06-26
03701037315897ORTHOPEDIC MANUAL SURGICAL INSTRUMENTFX SOLUTIONSPHX2026-06-26
03701037315903ORTHOPEDIC MANUAL SURGICAL INSTRUMENTFX SOLUTIONSPHX2026-06-26
03701037315910ORTHOPEDIC MANUAL SURGICAL INSTRUMENTFX SOLUTIONSPHX2026-06-26
03701037315927ORTHOPEDIC MANUAL SURGICAL INSTRUMENTFX SOLUTIONSPHX2026-06-26
03701037315934ORTHOPEDIC MANUAL SURGICAL INSTRUMENTFX SOLUTIONSPHX2026-06-26
03701037315941ORTHOPEDIC MANUAL SURGICAL INSTRUMENTFX SOLUTIONSPHX2026-06-26
03701037315958ORTHOPEDIC MANUAL SURGICAL INSTRUMENTFX SOLUTIONSPHX2026-06-26
03701037315965ORTHOPEDIC MANUAL SURGICAL INSTRUMENTFX SOLUTIONSPHX2026-06-26
03701037315972ORTHOPEDIC MANUAL SURGICAL INSTRUMENTFX SOLUTIONSPHX2026-06-26
03701037315989ORTHOPEDIC MANUAL SURGICAL INSTRUMENTFX SOLUTIONSPHX2026-06-26
03701037315996ORTHOPEDIC MANUAL SURGICAL INSTRUMENTFX SOLUTIONSPHX2026-06-26
03701037316009ORTHOPEDIC MANUAL SURGICAL INSTRUMENTFX SOLUTIONSPHX2026-06-26
03701037316535ORTHOPEDIC MANUAL SURGICAL INSTRUMENTFX SOLUTIONSPHX2026-06-26
03701037316542ORTHOPEDIC MANUAL SURGICAL INSTRUMENTFX SOLUTIONSPHX2026-06-26
03701037316559ORTHOPEDIC MANUAL SURGICAL INSTRUMENTFX SOLUTIONSPHX2026-06-26
03701037316566ORTHOPEDIC MANUAL SURGICAL INSTRUMENTFX SOLUTIONSPHX2026-06-26
00840097536668Veritas rTSA InstrumentationRestor3d, Inc.PHX2026-06-25
03701037300718HUMELOCKFX SOLUTIONSPHX2026-06-25
03701037307984HUMELOCKFX SOLUTIONSPHX2026-06-25
03701037308486ORTHOPEDIC MANUAL SURGICAL INSTRUMENTFX SOLUTIONSPHX2026-06-25
03701037308493ORTHOPEDIC MANUAL SURGICAL INSTRUMENTFX SOLUTIONSPHX2026-06-25
03701037308509ORTHOPEDIC MANUAL SURGICAL INSTRUMENTFX SOLUTIONSPHX2026-06-25
03701037310595Humeral Cup StandardFX SOLUTIONSPHX2026-06-25
03701037310601Humeral Cup StandardFX SOLUTIONSPHX2026-06-25
03701037311325ORTHOPEDIC MANUAL SURGICAL INSTRUMENTFX SOLUTIONSPHX2026-06-25
03701037311332ORTHOPEDIC MANUAL SURGICAL INSTRUMENTFX SOLUTIONSPHX2026-06-25
03701037311349ORTHOPEDIC MANUAL SURGICAL INSTRUMENTFX SOLUTIONSPHX2026-06-25
03701037315835ORTHOPEDIC MANUAL SURGICAL INSTRUMENTFX SOLUTIONSPHX2026-06-25
03701037315842ORTHOPEDIC MANUAL SURGICAL INSTRUMENTFX SOLUTIONSPHX2026-06-25