FDA.reportPublic FDA data

Bespoke

Primary DI
E314KNMCO030001
Brand
Bespoke
Company
MATERIALISE USA, L.L.C.
Model
KNM-CO03-00-01
Catalog number
KNM-CO03-00-01
Device description
Consensus MRI TKA femur guide and bone model
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
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
K150928000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K150928000Materialise TKA Guide System, Materialise TKA Planner, Materialise TKA GuidesMaterialise NV2015-08-10JWH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
E314KNMCO030001PrimaryHIBCC0

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

Regulatory Flags#

DUNS number
946657160
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
E314KNMCO010301BespokeKNM-CO01-03-01KNM-CO01-03-012016-09-24
E314KNMCO0103010BespokeKNM-CO01-03-01KNM-CO01-03-012017-07-21
E314KNMCO010401BespokeKNM-CO01-04-01KNM-CO01-04-012016-09-24
E314KNMCO0104010BespokeKNM-CO01-04-01KNM-CO01-04-012017-07-21
E314KNMCO010101BespokeKNM-CO01-01-01KNM-CO01-01-012016-09-24
E314KNMCO0101010BespokeKNM-CO01-01-01KNM-CO01-01-012017-07-21
E314KNMCO010201BespokeKNM-CO01-02-01KNM-CO01-02-012016-09-24
E314KNMCO0102010BespokeKNM-CO01-02-01KNM-CO01-02-012017-07-21
E314KNMCO020001BespokeKNM-CO02-00-01KNM-CO02-00-012016-09-24
E314KNMCO0200010BespokeKNM-CO02-00-01KNM-CO02-00-012017-07-21
E314KNMCO040001BespokeKNM-CO04-00-01KNM-CO04-00-012016-09-24
E314KNMCO0400010BespokeKNM-CO04-00-01KNM-CO04-00-012017-07-21
E314HPCCO0100010BespokeHPC-CO01-00-01HPC-CO01-00-012017-07-21
E314HPCCO0101010BespokeHPC-CO01-01-01HPC-CO01-01-012017-07-21
E314HPCCO010001BespokeHPC-CO01-00-01HPC-CO01-00-012016-09-24
E314HPCCO010101BespokeHPC-CO01-01-01HPC-CO01-01-012016-09-24
E314HPCCO010201BespokeHPC-CO01-02-01HPC-CO01-02-012016-09-24
E314HPCCO0102010BespokeHPC-CO01-02-01HPC-CO01-02-012017-07-21
E314KNMCO010001BespokeKNM-CO01-00-01KNM-CO01-00-012016-09-24
E314KNMCO0100010BespokeKNM-CO01-00-01KNM-CO01-00-012017-07-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840097536552iTotal Identity CR 3DP PorousRestor3d, Inc.OIY2026-07-31
00840097536552iTotal Identity CR 3DP PorousRestor3d, Inc.OOG2026-07-31
00840097536552iTotal Identity CR 3DP PorousRestor3d, Inc.MBH2026-07-31
00840097536552iTotal Identity CR 3DP PorousRestor3d, Inc.JWH2026-07-31
00840097536569iTotal Identity CR 3DP PorousRestor3d, Inc.OOG2026-07-31
00840097536569iTotal Identity CR 3DP PorousRestor3d, Inc.OIY2026-07-31
00840097536569iTotal Identity CR 3DP PorousRestor3d, Inc.JWH2026-07-31
00840097536569iTotal Identity CR 3DP PorousRestor3d, Inc.MBH2026-07-31
00840097536576iTotal Identity CR 3DP PorousRestor3d, Inc.OOG2026-07-31
00840097536576iTotal Identity CR 3DP PorousRestor3d, Inc.OIY2026-07-31
00840097536576iTotal Identity CR 3DP PorousRestor3d, Inc.JWH2026-07-31
00840097536576iTotal Identity CR 3DP PorousRestor3d, Inc.MBH2026-07-31
00840097536583iTotal Identity CR 3DP PorousRestor3d, Inc.MBH2026-07-31
00840097536583iTotal Identity CR 3DP PorousRestor3d, Inc.JWH2026-07-31
00840097536583iTotal Identity CR 3DP PorousRestor3d, Inc.OOG2026-07-31
00840097536583iTotal Identity CR 3DP PorousRestor3d, Inc.OIY2026-07-31
00840097536590iTotal Identity CR 3DP PorousRestor3d, Inc.OOG2026-07-31
00840097536590iTotal Identity CR 3DP PorousRestor3d, Inc.OIY2026-07-31
00840097536590iTotal Identity CR 3DP PorousRestor3d, Inc.JWH2026-07-31
00840097536590iTotal Identity CR 3DP PorousRestor3d, Inc.MBH2026-07-31
03701089509695AMPLITUDEAMPLITUDE SASJWH2026-07-31
03701089517492TRAXAMPLITUDE SASJWH2026-07-29
03701089517508TRAXAMPLITUDE SASJWH2026-07-29
03701089517515TRAXAMPLITUDE SASJWH2026-07-29
03701089517522TRAXAMPLITUDE SASJWH2026-07-29
03701089517539TRAXAMPLITUDE SASJWH2026-07-29
03701089517546TRAXAMPLITUDE SASJWH2026-07-29
03701089517553TRAXAMPLITUDE SASJWH2026-07-29
03701089517560TRAXAMPLITUDE SASJWH2026-07-29
03701089517577TRAXAMPLITUDE SASJWH2026-07-29