FDA.reportPublic FDA data

Lima PSI

Primary DI
E314KNMLM0104010
Brand
Lima PSI
Company
Materialise NV
Model
KNM-LM01-04-01
Catalog number
KNM-LM01-04-01
Device description
Lima MRI TKA tibia bone model
Published
2017-07-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
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
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
K162273000
K221337000
K251554000
K253793000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K162273000Materialise TKA Guide SystemMaterialise NV2016-11-07JWH
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
E314KNMLM010401PreviousHIBCC0
E314KNMLM0104010PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Custom-made organ/bone anatomy modelA model of an organ (e.g., heart, kidney, lung) or bone of a specific patient intended to be used to assist anatomical visualization and surgical treatment planning. It is created using additive (three-dimensional [3-D] printing) processes based on patient medical images. It is typically made of a synthetic polymer, marked with a unique identifier, and may be sterilized prior to use in sterile fields.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
373139427
Device count
1
Lot or batch
true
Manufacturing date on label
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
TKRL0001F1540PointCloud Knee InstrumentsUnik Orthopedics Inc.MBH2026-10-20
TKRL0001F1540PointCloud Knee InstrumentsUnik Orthopedics Inc.OOG2026-10-20
TKRL0001F1540PointCloud Knee InstrumentsUnik Orthopedics Inc.JWH2026-10-20
TKRL0001F1B80PointCloud Knee InstrumentsUnik Orthopedics Inc.JWH2026-10-20
TKRL0001F1B80PointCloud Knee InstrumentsUnik Orthopedics Inc.OOG2026-10-20
TKRL0001F1B80PointCloud Knee InstrumentsUnik Orthopedics Inc.MBH2026-10-20
TKRL0001F34K0PointCloud Knee InstrumentsUnik Orthopedics Inc.JWH2026-10-20
TKRL0001F34K0PointCloud Knee InstrumentsUnik Orthopedics Inc.OOG2026-10-20
TKRL0001F34K0PointCloud Knee InstrumentsUnik Orthopedics Inc.MBH2026-10-20
TKRL0001F6000PointCloud Knee InstrumentsUnik Orthopedics Inc.JWH2026-10-20
TKRL0001F6000PointCloud Knee InstrumentsUnik Orthopedics Inc.MBH2026-10-20
TKRL0001F6000PointCloud Knee InstrumentsUnik Orthopedics Inc.OOG2026-10-20
TKRL0001F7300PointCloud Knee InstrumentsUnik Orthopedics Inc.JWH2026-10-20
TKRL0001F7300PointCloud Knee InstrumentsUnik Orthopedics Inc.OOG2026-10-20
TKRL0001F7300PointCloud Knee InstrumentsUnik Orthopedics Inc.MBH2026-10-20
TKRL0001F7940PointCloud Knee InstrumentsUnik Orthopedics Inc.OOG2026-10-20
TKRL0001F7940PointCloud Knee InstrumentsUnik Orthopedics Inc.MBH2026-10-20
TKRL0001F7940PointCloud Knee InstrumentsUnik Orthopedics Inc.JWH2026-10-20
TKRL0001F7F80PointCloud Knee InstrumentsUnik Orthopedics Inc.MBH2026-10-20
TKRL0001F7F80PointCloud Knee InstrumentsUnik Orthopedics Inc.JWH2026-10-20
TKRL0001F7F80PointCloud Knee InstrumentsUnik Orthopedics Inc.OOG2026-10-20
TKRL0001F9F00PointCloud Knee InstrumentsUnik Orthopedics Inc.MBH2026-10-20
TKRL0001F9F00PointCloud Knee InstrumentsUnik Orthopedics Inc.JWH2026-10-20
TKRL0001F9F00PointCloud Knee InstrumentsUnik Orthopedics Inc.OOG2026-10-20
TKRL0001FF640PointCloud Knee InstrumentsUnik Orthopedics Inc.JWH2026-10-20
TKRL0001FF640PointCloud Knee InstrumentsUnik Orthopedics Inc.OOG2026-10-20
TKRL0001FF640PointCloud Knee InstrumentsUnik Orthopedics Inc.MBH2026-10-20
TKRL0001FLI00PointCloud Knee InstrumentsUnik Orthopedics Inc.MBH2026-10-20
TKRL0001FLI00PointCloud Knee InstrumentsUnik Orthopedics Inc.OOG2026-10-20
TKRL0001FLI00PointCloud Knee InstrumentsUnik Orthopedics Inc.JWH2026-10-20