FDA.reportPublic FDA data

Signature

Primary DI
E314421004000
Brand
Signature
Company
Materialise NV
Model
42-100400
Catalog number
42-100400
Device description
Guide/Bone Model Set
Published
2017-07-21
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
JDIProsthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
KWYProsthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
KWZProsthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer
LPHProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
LZPAid, Surgical, Viscoelastic
MAYProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish
MEHProsthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JDIProsthesis, Hip, Semi-Constrained, Metal/Polymer, CementedOrthopedic2
KWYProsthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or UncementedOrthopedic2
KWZProsthesis, Hip, Constrained, Cemented Or Uncemented, Metal/PolymerOrthopedic2
LPHProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous UncementedOrthopedic2
LZPAid, Surgical, ViscoelasticOphthalmic3
MAYProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic FinishOrthopedic2
MEHProsthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium PhosphateOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K111863000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K111863000SIGNATURE PLANNER,SIGNATURE GUIDESMaterialise NV2012-06-15JDI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
E31442100400PreviousHIBCC0
E314421004000PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Custom-made organ/bone anatomy model/surgical guide kitA collection of custom-made devices intended to be used to assist anatomical visualization, surgical treatment planning, and intraoperative surgical procedures (e.g., orientation of implant components, guiding of surgical instruments). It consists of an anatomy model(s) of an organ/bone and an orthopaedic/craniomaxillofacial surgical guide(s) [e.g., for osteotomy, arthroplasty]; it is made of synthetic polymer materials and is manufactured by 3-D printing and CAD/CAM techniques to match the patient-specific contours of the target anatomical site. This is a single-use device intended to be sterilized prior to use.

Sterilization Methods#

Method table
Method
"[""Hydrogen Peroxide"", ""Moist Heat or Steam Sterilization""]"
Hydrogen Peroxide;Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
373139427
Device count
1
Lot or batch
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05420060351228TruMatch CMF Titanium 3D Printed SplintsSD980.030SD980.0302026-10-20
E314SHCLM010101Lima PSISHC-LM01-01-01SHC-LM01-01-012016-12-01
E314SHCLM020101Lima PSISHC-LM02-01-01SHC-LM02-01-012016-12-01
E31480403057Match Point System804-03-057804-03-0572016-09-24
E31480425148Match Point System804-25-148804-25-1482016-09-24
E314SHCLM010001Lima PSISHC-LM01-00-01SHC-LM01-00-012016-12-01
E314SHCLM010201Lima PSISHC-LM01-02-01SHC-LM01-02-012016-12-01
E314SHCLM020001Lima PSISHC-LM02-00-01SHC-LM02-00-012016-12-01
E314SHCLM020201Lima PSISHC-LM02-02-01SHC-LM02-02-012016-12-01
E31442100200Signature42-10020042-1002002026-09-24
E31442100300Signature42-10030042-1003002026-09-24
E31442411410Signature42-41141042-4114102026-09-24
E31442422415Signature42-42241542-4224152026-09-24
E31442422450Signature42-42245042-4224502026-09-24
E31442422451Signature42-42245142-4224512026-09-24
E31442422452Signature42-42245242-4224522026-09-24
E31442422453Signature42-42245342-4224532026-09-24
E31442422455Signature42-42245542-4224552026-09-24
E31442422456Signature42-42245642-4224562026-09-24
E31442422457Signature42-42245742-4224572026-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04719886896602United Hip SystemUNITED ORTHOPEDIC CORP.MEH2026-10-15
04719886896602United Hip SystemUNITED ORTHOPEDIC CORP.LPH2026-10-15
04719886899030United Hip SystemUNITED ORTHOPEDIC CORP.MEH2026-10-15
04719886899030United Hip SystemUNITED ORTHOPEDIC CORP.LPH2026-10-15
04719886899047United Hip SystemUNITED ORTHOPEDIC CORP.MEH2026-10-15
04719886899047United Hip SystemUNITED ORTHOPEDIC CORP.LPH2026-10-15
04719886899054United Hip SystemUNITED ORTHOPEDIC CORP.MEH2026-10-15
04719886899054United Hip SystemUNITED ORTHOPEDIC CORP.LPH2026-10-15
04719886899061United Hip SystemUNITED ORTHOPEDIC CORP.MEH2026-10-15
04719886899061United Hip SystemUNITED ORTHOPEDIC CORP.LPH2026-10-15
04719886899078United Hip SystemUNITED ORTHOPEDIC CORP.MEH2026-10-15
04719886899078United Hip SystemUNITED ORTHOPEDIC CORP.LPH2026-10-15
04719886899085United Hip SystemUNITED ORTHOPEDIC CORP.MEH2026-10-15
04719886899085United Hip SystemUNITED ORTHOPEDIC CORP.LPH2026-10-15
04719886899092United Hip SystemUNITED ORTHOPEDIC CORP.MEH2026-10-15
04719886899092United Hip SystemUNITED ORTHOPEDIC CORP.LPH2026-10-15
04719886899108United Hip SystemUNITED ORTHOPEDIC CORP.MEH2026-10-15
04719886899108United Hip SystemUNITED ORTHOPEDIC CORP.LPH2026-10-15
04719886899115United Hip SystemUNITED ORTHOPEDIC CORP.MEH2026-10-15
04719886899115United Hip SystemUNITED ORTHOPEDIC CORP.LPH2026-10-15
04719886899122United Hip SystemUNITED ORTHOPEDIC CORP.MEH2026-10-15
04719886899122United Hip SystemUNITED ORTHOPEDIC CORP.LPH2026-10-15
04719886899139United Hip SystemUNITED ORTHOPEDIC CORP.MEH2026-10-15
04719886899139United Hip SystemUNITED ORTHOPEDIC CORP.LPH2026-10-15
04719886899146United Hip SystemUNITED ORTHOPEDIC CORP.MEH2026-10-15
04719886899146United Hip SystemUNITED ORTHOPEDIC CORP.LPH2026-10-15
04719886899153United Hip SystemUNITED ORTHOPEDIC CORP.MEH2026-10-15
04719886899153United Hip SystemUNITED ORTHOPEDIC CORP.LPH2026-10-15
04719886899160United Hip SystemUNITED ORTHOPEDIC CORP.MEH2026-10-15
04719886899160United Hip SystemUNITED ORTHOPEDIC CORP.LPH2026-10-15