FDA.reportPublic FDA data

SurgiCase Planner

Primary DI
05404028000922
Brand
SurgiCase Planner
Company
Materialise NV
Model
SurgiCase Knee Planner
Catalog number
SurgiCase Knee Planner
Device description
SurgiCase Knee Planner
Published
2025-05-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
HSXProsthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer
JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
MBHProsthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
OIYProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive
OOGKnee Arthroplasty Implantation System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HSXProsthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/PolymerOrthopedic2
JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/PolymerOrthopedic2
MBHProsthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/PolymerOrthopedic2
OIYProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + AdditiveOrthopedic2
OOGKnee Arthroplasty Implantation SystemOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K150928000
K162273000
K172650000
K173445000
K173970000
K202207000
K221337000
K251554000
K253793000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K150928000Materialise TKA Guide System, Materialise TKA Planner, Materialise TKA GuidesMaterialise NV2015-08-10JWH
K162273000Materialise TKA Guide SystemMaterialise NV2016-11-07JWH
K172650000Materialise PKA Guide SystemMaterialise NV2017-11-20HSX
K173445000Materialise TKA Guide SystemMaterialise NV2018-02-02JWH
K173970000Materialise PKA Guide SystemMaterialise NV2018-07-06HSX
K202207000Materialise PKA Guide SystemMaterialise NV2020-10-02HSX
K221337000Materialise TKA Guide SystemMaterialise NV2022-07-05JWH
K251554000Materialise TKA Guide SystemMaterialise NV2025-07-14JWH
K253793000Materialise TKA Guide SystemMaterialise NV2026-01-06JWH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05404028000922PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05404028000922054040280009225404028000922

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). It may include functionality to upload patient-specific images and to facilitate communication between healthcare professionals.

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
05404028001288SurgiCase PlannerSurgiCase Shoulder PlannerSurgiCase Shoulder Planner2026-07-16
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00885556923023NASmith & Nephew, Inc.JWH2026-07-16
09348215046019World Knee Cemented Titanium Tibial Plate - Modular - Size 1 - 40mmSIGNATURE ORTHOPAEDICS PTY LTDMBH2026-06-26
09348215046026World Knee Cemented Titanium Tibial Plate - Modular - Size 2 - 40mmSIGNATURE ORTHOPAEDICS PTY LTDMBH2026-06-26
09348215046033World Knee Cemented Titanium Tibial Plate - Modular - Size 3 - 40mmSIGNATURE ORTHOPAEDICS PTY LTDMBH2026-06-26
09348215046040World Knee Cemented Titanium Tibial Plate - Modular - Size 4 - 40mmSIGNATURE ORTHOPAEDICS PTY LTDMBH2026-06-26
09348215046057World Knee Cemented Titanium Tibial Plate - Modular - Size 5 - 40mmSIGNATURE ORTHOPAEDICS PTY LTDMBH2026-06-26
09348215046064World Knee Cemented Titanium Tibial Plate - Modular - Size 6 - 40mmSIGNATURE ORTHOPAEDICS PTY LTDMBH2026-06-26
09348215046071World Knee Cemented Titanium Tibial Plate - Modular - Size 7 - 40mmSIGNATURE ORTHOPAEDICS PTY LTDMBH2026-06-26
09348215046088World Knee Cemented Titanium Tibial Plate - Modular - Size 8 - 40mmSIGNATURE ORTHOPAEDICS PTY LTDMBH2026-06-26
09348215046095World Knee Cemented Titanium Tibial Plate - Modular - Size 9 - 40mmSIGNATURE ORTHOPAEDICS PTY LTDMBH2026-06-26
09348215161088World Knee CR TiN Cementless Femur - Size 2 RightSIGNATURE ORTHOPAEDICS PTY LTDMBH2026-06-26
09348215161095World Knee CR TiN Cementless Femur - Size 3 RightSIGNATURE ORTHOPAEDICS PTY LTDMBH2026-06-26
09348215161101World Knee CR TiN Cementless Femur - Size 4 RightSIGNATURE ORTHOPAEDICS PTY LTDMBH2026-06-26
09348215161118World Knee CR TiN Cementless Femur - Size 5 RightSIGNATURE ORTHOPAEDICS PTY LTDMBH2026-06-26
09348215161125World Knee CR TiN Cementless Femur - Size 6 RightSIGNATURE ORTHOPAEDICS PTY LTDMBH2026-06-26
09348215161132World Knee CR TiN Cementless Femur - Size 7 RightSIGNATURE ORTHOPAEDICS PTY LTDMBH2026-06-26
09348215161149World Knee CR TiN Cementless Femur - Size 8 RightSIGNATURE ORTHOPAEDICS PTY LTDMBH2026-06-26
09348215161156World Knee CR TiN Cementless Femur - Size 9 RightSIGNATURE ORTHOPAEDICS PTY LTDMBH2026-06-26
09348215161163World Knee Cementless Titanium Tibial Plate - Modular - Size 1 - 40mmSIGNATURE ORTHOPAEDICS PTY LTDMBH2026-06-26
09348215161170World Knee Cementless Titanium Tibial Plate - Modular - Size 2 - 40mmSIGNATURE ORTHOPAEDICS PTY LTDMBH2026-06-26
09348215161187World Knee Cementless Titanium Tibial Plate - Modular - Size 3 - 40mmSIGNATURE ORTHOPAEDICS PTY LTDMBH2026-06-26
09348215161194World Knee Cementless Titanium Tibial Plate - Modular - Size 4 - 40mmSIGNATURE ORTHOPAEDICS PTY LTDMBH2026-06-26
09348215161200World Knee Cementless Titanium Tibial Plate - Modular - Size 5 - 40mmSIGNATURE ORTHOPAEDICS PTY LTDMBH2026-06-26
09348215161217World Knee Cementless Titanium Tibial Plate - Modular - Size 6 - 40mmSIGNATURE ORTHOPAEDICS PTY LTDMBH2026-06-26
09348215161224World Knee Cementless Titanium Tibial Plate - Modular - Size 7 - 40mmSIGNATURE ORTHOPAEDICS PTY LTDMBH2026-06-26
09348215161231World Knee Cementless Titanium Tibial Plate - Modular - Size 8 - 40mmSIGNATURE ORTHOPAEDICS PTY LTDMBH2026-06-26
09348215161248World Knee Cementless Titanium Tibial Plate - Modular - Size 9 - 40mmSIGNATURE ORTHOPAEDICS PTY LTDMBH2026-06-26
09348215161255World Knee Cementless Titanium Tibial Plate - Modular - Size 1 - 80mmSIGNATURE ORTHOPAEDICS PTY LTDMBH2026-06-26
09348215161262World Knee Cementless Titanium Tibial Plate - Modular - Size 2 - 80mmSIGNATURE ORTHOPAEDICS PTY LTDMBH2026-06-26
09348215161279World Knee Cementless Titanium Tibial Plate - Modular - Size 3 - 80mmSIGNATURE ORTHOPAEDICS PTY LTDMBH2026-06-26