FDA.reportPublic FDA data

Blueprint

Primary DI
03700434015065
Brand
Blueprint
Company
TORNIER
Model
BPUE001
Catalog number
4.0.Mac
Device description
Mac
Published
2023-02-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
QHEShoulder arthroplasty implantation system

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QHEShoulder Arthroplasty Implantation SystemOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03700434015065PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03700434015065037004340150653700434015065

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
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03700434023831BlueprintBPUE0014.2.Mac2025-06-17
03700434023848BlueprintBPUE0014.2.Win2025-06-17
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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00840097513126Veritas Reverse Total ShoulderRestor3d, Inc.QHE2026-07-24
00840097513133Veritas Reverse Total ShoulderRestor3d, Inc.QHE2026-07-24
00840097516004Veritas Reverse Total ShoulderRestor3d, Inc.QHE2026-07-24
00840097516011Veritas Reverse Total ShoulderRestor3d, Inc.QHE2026-07-24
05404028001288SurgiCase PlannerMaterialise NVQHE2026-07-16
00889024707047Signature ONE Software PackageOrthosoft IncQHE2026-07-10
05404028001110SurgiCase Planner Materialise NVQHE2025-12-17
05404028001028SurgiCase PlannerMaterialise NVQHE2025-08-28
03700434023831BlueprintTORNIERQHE2025-06-17
03700434023848BlueprintTORNIERQHE2025-06-17
00810022403051CORE Shoulder SystemLink Bio CorpQHE2025-06-04
00810022403068CORE Shoulder SystemLink Bio CorpQHE2025-06-04
00810022403099CORE Shoulder SystemLink Bio CorpQHE2025-06-04
00810022403105CORE Shoulder SystemLink Bio CorpQHE2025-06-04
00810022403129CORE Shoulder SystemLink Bio CorpQHE2025-06-04
00810022403136CORE Shoulder SystemLink Bio CorpQHE2025-06-04
00810022403143CORE Shoulder SystemLink Bio CorpQHE2025-06-04
00810022403150CORE Shoulder SystemLink Bio CorpQHE2025-06-04
00810022403167CORE Shoulder SystemLink Bio CorpQHE2025-06-04
00810022403174CORE Shoulder SystemLink Bio CorpQHE2025-06-04
00810022403181CORE Shoulder SystemLink Bio CorpQHE2025-06-04
00810022403198CORE Shoulder SystemLink Bio CorpQHE2025-06-04
00810022403204CORE Shoulder SystemLink Bio CorpQHE2025-06-04
00888867498952Arthrex®ARTHREX, INC.QHE2025-05-01
00888867498969Arthrex®ARTHREX, INC.QHE2025-05-01
00888867498976Arthrex®ARTHREX, INC.QHE2025-05-01
07630542730153MyShoulder PlannerMedacta International SAQHE2025-02-06
05420060366116Match Point SystemMaterialise NVQHE2024-12-09
05420060366123Match Point SystemMaterialise NVQHE2024-12-09