FDA.reportPublic FDA data

ACO Planner

Primary DI
E314ACOPLANNER0
Brand
ACO Planner
Company
Materialise NV
Model
ACO Planner
Catalog number
ACO Planner
Device description
ACO Planner
Published
2017-02-10
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
PLWAcetabular Cup Orientation System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PLWAcetabular Cup Orientation SystemOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K150780000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K150780000Acetabular Cup Orientation SystemMaterialise NV2015-10-27PLW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
E314ACOPLANNER0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
CAD/CAM softwareA software program intended to provide computer-aided design (CAD) or computer-aided manufacturing (CAM) functionality for the production of patient-specific custom-made devices (e.g., orthopaedic implants, dental devices, anatomical models), treatment planning, simulation, and/or robotic capabilities for device production (e.g., 3-D printing).

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
373139427
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05404028001257SurgiCase PlannerSurgiCase Knee PlannerSurgiCase Knee Planner2026-05-28
05404028007006OrthoViewOrthoViewOrthoView2026-05-22
05404028001196Mimics Cardiac PlannerMimics Cardiac Planner TAVRMimics Cardiac Planner TAVR2026-05-15
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
05404028001202Mimics Automatic AlgorithmsMimics Automatic Algorithms CMF Orthognathic CT CBMimics Automatic Algorithms CMF Orthognathic CT CB2026-04-20
05404028001219Mimics Automatic Algorithms Mimics Automatic Algorithms CMF Reconstruction CT Mimics Automatic Algorithms CMF Reconstruction CT 2026-04-20
05404028001226Mimics Automatic Algorithms Mimics Automatic Algorithms Knee MRIMimics Automatic Algorithms Knee MRI2026-04-20
05404028001080Materialise Mimics Enlight CMFOrthognathic and Trauma PlannerOrthognathic and Trauma Planner2026-04-10
05404028001097Materialise Mimics Enlight CMFReconstruction PlannerReconstruction Planner2026-04-10
05404028001103Materialise Mimics Enlight CMFSplint DesignerSplint Designer2026-04-10
05404028001158Mimics FlowMimics FlowMimics Flow2026-03-23
05404028001172SurgiCase OnlineSurgiCase OnlineSurgiCase Online2026-03-23
05404028001189ProPlan CMF ProPlan CMF Online ProPlan CMF Online 2026-03-23
05404028000861Mimics Thoracic PlannerMimics Thoracic PlannerMimics Thoracic Planner2026-03-20
05420060360015BKS Total PSIKNM-OD01-00-01KNM-OD01-00-01 2022-09-21
05420060310027Zimmer Biomet Patient Specific InstrumentsKNM-ZB02-00-01KNM-ZB02-00-012018-08-11
05420060310034Zimmer Biomet Patient Specific InstrumentsKNM-ZB03-00-01KNM-ZB03-00-012018-08-11
05420060310041Zimmer Biomet Patient Specific InstrumentsKNM-ZB04-00-01KNM-ZB04-00-012018-08-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
09351327000374OPS™ FHAOPTIMIZED ORTHO PTY LTDPLW2019-11-11
E314HPCCO0100010BespokeMATERIALISE USA, L.L.C.PLW2017-07-21
E314HPCCO0101010BespokeMATERIALISE USA, L.L.C.PLW2017-07-21
E314HPCCO0102010BespokeMATERIALISE USA, L.L.C.PLW2017-07-21
E314O02055700000113000SurgiCaseMaterialise NVPLW2017-07-21
E314HPCCO010001BespokeMATERIALISE USA, L.L.C.PLW2016-09-24
E314HPCCO010101BespokeMATERIALISE USA, L.L.C.PLW2016-09-24
E314HPCCO010201BespokeMATERIALISE USA, L.L.C.PLW2016-09-24
E314O0205570000011300SurgiCaseMaterialise NVPLW2016-09-24