FDA.reportPublic FDA data

Bespoke

Primary DI
E314KNMCO010101
Brand
Bespoke
Company
MATERIALISE USA, L.L.C.
Model
KNM-CO01-01-01
Catalog number
KNM-CO01-01-01
Device description
Consensus MRI TKA femur guide
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
E314KNMCO010101PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Custom-made orthopaedic surgical guide, non-sterileA non-sterile, custom-made surgical instrument intended to be used in an orthopaedic and/or craniomaxillofacial procedure (e.g., osteotomy, arthroplasty, tumour resection, distraction osteogenesis, cranial vault reconstruction) to assist in the intraoperative orientation of implant components, outlining the desired cut-line, and/or guiding of surgical instruments (e.g., surgical drill, oscillating cutting saw). It is made of synthetic polymer materials and is typically 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
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
E314KNMCO030001BespokeKNM-CO03-00-01KNM-CO03-00-012016-09-24

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