FDA.reportPublic FDA data

Signature

Primary DI
E31442100200
Brand
Signature
Company
Materialise NV
Model
42-100200
Catalog number
42-100200
Device description
Bone Model THA
Published
2026-09-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
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
E31442100200PrimaryHIBCC0

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
373139427
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05404028001394SurgiCase Shoulder PlannerSurgiCase Shoulder PlannerSurgiCase Shoulder Planner2026-11-03
05404028001370Mimics Cardiac PlannerMimics Cardiac Planner TAVRMimics Cardiac Planner TAVR2026-10-30
05420060351235TRUMATCHSD980.041SD980.0412026-10-22
05420060351242TRUMATCHSD980.042SD980.0422026-10-22
05420060351259TRUMATCHSD980.043SD980.0432026-10-22
05420060351266TRUMATCHSD980.044SD980.0442026-10-22
05420060351273TRUMATCHSD980.045SD980.0452026-10-22
05420060351280TRUMATCHSD980.046SD980.0462026-10-22
05420060351297TRUMATCHSD980.047SD980.0472026-10-22
05420060351303TRUMATCHSD980.048SD980.0482026-10-22
05420060351310TRUMATCHSD980.049SD980.0492026-10-22
05420060351327TRUMATCHSD980.050SD980.0502026-10-22
05420060351334TRUMATCHSD980.051SD980.0512026-10-22
05420060351341TRUMATCHSD980.052SD980.0522026-10-22
05420060351358TRUMATCHSD980.053SD980.0532026-10-22
05420060351365TRUMATCHSD980.054SD980.0542026-10-22
05420060351372TRUMATCHSD980.055SD980.0552026-10-22
05420060351389TRUMATCHSD980.056SD980.0562026-10-22
05420060351396TRUMATCHSD980.057SD980.0572026-10-22
05420060351402TRUMATCHSD980.058SD980.0582026-10-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00889024713512G7® TM Acetabular SystemZimmer, Inc.KWZ2026-11-03
00889024713512G7® TM Acetabular SystemZimmer, Inc.LPH2026-11-03
00889024713529G7® TM Acetabular SystemZimmer, Inc.KWZ2026-11-03
00889024713529G7® TM Acetabular SystemZimmer, Inc.LPH2026-11-03
00889024713536G7® TM Acetabular SystemZimmer, Inc.LPH2026-11-03
00889024713536G7® TM Acetabular SystemZimmer, Inc.KWZ2026-11-03
00889024713543G7® TM Acetabular SystemZimmer, Inc.KWZ2026-11-03
00889024713543G7® TM Acetabular SystemZimmer, Inc.LPH2026-11-03
00889024713550G7® TM Acetabular SystemZimmer, Inc.KWZ2026-11-03
00889024713550G7® TM Acetabular SystemZimmer, Inc.LPH2026-11-03
00889024713567G7® TM Acetabular SystemZimmer, Inc.KWZ2026-11-03
00889024713567G7® TM Acetabular SystemZimmer, Inc.LPH2026-11-03
00889024713574G7® TM Acetabular SystemZimmer, Inc.LPH2026-11-03
00889024713574G7® TM Acetabular SystemZimmer, Inc.KWZ2026-11-03
00889024713581G7® TM Acetabular SystemZimmer, Inc.KWZ2026-11-03
00889024713581G7® TM Acetabular SystemZimmer, Inc.LPH2026-11-03
00889024713598G7® TM Acetabular SystemZimmer, Inc.LPH2026-11-03
00889024713598G7® TM Acetabular SystemZimmer, Inc.KWZ2026-11-03
00889024713604G7® TM Acetabular SystemZimmer, Inc.LPH2026-11-03
00889024713604G7® TM Acetabular SystemZimmer, Inc.KWZ2026-11-03
00889024713611G7® TM Acetabular SystemZimmer, Inc.LPH2026-11-03
00889024713611G7® TM Acetabular SystemZimmer, Inc.KWZ2026-11-03
00889024713628G7® TM Acetabular SystemZimmer, Inc.KWZ2026-11-03
00889024713628G7® TM Acetabular SystemZimmer, Inc.LPH2026-11-03
00889024713635G7® TM Acetabular SystemZimmer, Inc.LPH2026-11-03
00889024713635G7® TM Acetabular SystemZimmer, Inc.KWZ2026-11-03
00889024713642G7® TM Acetabular SystemZimmer, Inc.LPH2026-11-03
00889024713642G7® TM Acetabular SystemZimmer, Inc.KWZ2026-11-03
00889024713659G7® TM Acetabular SystemZimmer, Inc.LPH2026-11-03
00889024713659G7® TM Acetabular SystemZimmer, Inc.KWZ2026-11-03