FDA.reportPublic FDA data

Signature

Primary DI
E31442100400
Brand
Signature
Company
Materialise NV
Model
42-100400
Catalog number
42-100400
Device description
Guide/Bone Model Set
Published
2016-09-24
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
E31442100400PrimaryHIBCC0

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

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
05420060350856TruMatch CMF Titanium 3D Printed GuidesSD980.060SD980.0602026-04-29
05420060351631TruMatch CMF Titanium 3D Printed GuidesSD980.064SD980.0642026-04-29
05420060351648TruMatch CMF Titanium 3D Printed GuidesSD980.065SD980.0652026-04-29
05420060380747TRUMATCHSD980.028SD980.0282025-02-28
05420060363191TruMatch Personalised Solutions Shoulder System2255010032255010032022-03-11
E314KNMLM010101Lima PSIKNM-LM01-01-01KNM-LM01-01-012016-12-01
E314KNMLM0101010Lima PSIKNM-LM01-01-01KNM-LM01-01-012017-07-21
E314KNMLM010201Lima PSIKNM-LM01-02-01KNM-LM01-02-012016-12-01
E314KNMLM0102010Lima PSIKNM-LM01-02-01KNM-LM01-02-012017-07-21
E314KNMLM020001Lima PSIKNM-LM02-00-01KNM-LM02-00-012016-12-01
E314KNMLM0200010Lima PSIKNM-LM02-00-01KNM-LM02-00-012017-07-21
E314SHCLM010101Lima PSISHC-LM01-01-01SHC-LM01-01-012016-12-01
E314SHCLM0101010Lima PSISHC-LM01-01-01SHC-LM01-01-012017-07-21
E314SHCLM020101Lima PSISHC-LM02-01-01SHC-LM02-01-012016-12-01
E314SHCLM0201010Lima PSISHC-LM02-01-01SHC-LM02-01-012017-07-21
05420060381041TruMatchSD980.104SD980.1042020-03-16
05420060351013ProPlan CMFSD900.101SD900.1012016-09-13
05420060351020ProPlan CMFSD900.102SD900.1022016-09-13
05420060351044ProPlan CMFSD900.104SD900.1042016-09-13
05420060351051ProPlan CMFSD900.105SD900.1052016-09-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07630030883576Mpact 3D Metal FoamMedacta International SALPH2026-09-04
07630030883583Mpact 3D Metal FoamMedacta International SALPH2026-09-04
07630030883590Mpact 3D Metal FoamMedacta International SALPH2026-09-04
07630030883606Mpact 3D Metal FoamMedacta International SALPH2026-09-04
07630030883613Mpact 3D Metal FoamMedacta International SALPH2026-09-04
07630030883620Mpact 3D Metal FoamMedacta International SALPH2026-09-04
07630030883637Mpact 3D Metal FoamMedacta International SALPH2026-09-04
07630030883644Mpact 3D Metal FoamMedacta International SALPH2026-09-04
07630030883651Mpact 3D Metal FoamMedacta International SALPH2026-09-04
07630030883668Mpact 3D Metal FoamMedacta International SALPH2026-09-04
07630030883675Mpact 3D Metal FoamMedacta International SALPH2026-09-04
07630030883682Mpact 3D Metal FoamMedacta International SALPH2026-09-04
07630030883699Mpact 3D Metal FoamMedacta International SALPH2026-09-04
07630030883705Mpact 3D Metal FoamMedacta International SALPH2026-09-04
07630030883712Mpact 3D Metal FoamMedacta International SALPH2026-09-04
07630030883729Mpact 3D Metal FoamMedacta International SALPH2026-09-04
07630030883736Mpact 3D Metal FoamMedacta International SALPH2026-09-04
07630030883743Mpact 3D Metal FoamMedacta International SALPH2026-09-04
07630030883750Mpact 3D Metal FoamMedacta International SALPH2026-09-04
07630030883767Mpact 3D Metal FoamMedacta International SALPH2026-09-04
07630030883774Mpact 3D Metal FoamMedacta International SALPH2026-09-04
07630030883781Mpact 3D Metal FoamMedacta International SALPH2026-09-04
07630030883798Mpact 3D Metal FoamMedacta International SALPH2026-09-04
07630030883804Mpact 3D Metal FoamMedacta International SALPH2026-09-04
07630030883811Mpact 3D Metal FoamMedacta International SALPH2026-09-04
07630030883828Mpact 3D Metal FoamMedacta International SALPH2026-09-04
07630030883835Mpact 3D Metal FoamMedacta International SALPH2026-09-04
07630030883842Mpact 3D Metal FoamMedacta International SALPH2026-09-04
07630030883859Mpact 3D Metal FoamMedacta International SALPH2026-09-04
07630030883866Mpact 3D Metal FoamMedacta International SALPH2026-09-04