FDA.reportPublic FDA data

Evolution

Primary DI
M684ETPSB6SR1
Brand
Evolution
Company
Microport Orthopedics Inc.
Model
ETPSB6SR
Catalog number
ETPSB6SR
Device description
EVOLUTION®MP TIB SCREW BF SIZE 6 STANDARD RIGHT
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MBHProsthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MBHProsthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/PolymerOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K894334000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K894334000SECOND GENERATION KNEE SYSTEMOrthomet, Inc.1989-10-06JWH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M684ETPSB6SR1PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Coated knee tibia prosthesisA sterile implantable device designed to replace the tibial condyles (tibial component) during primary bicondylar replacement of the knee joint or to replace a dysfunctional knee prosthesis (revision); it is made of metal [e.g., cobalt-chrome (Co-Cr)] and is coated with a material (e.g., beads, hydroxyapatite, mesh) intended to improve fixation and stability by promoting bone ingrowth. The device is designed to articulate with an insert and the femoral prosthetic component of the knee joint and its implantation may be performed with or without bone cement.

Contacts#

Phone, Email table
PhoneEmail
1-866-872-0211customerservice2@ortho.microport.com

Regulatory Flags#

DUNS number
079118736
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00192629005419ADVANCE®KPONTP26KPONTP262026-09-18
00192629005426ADVANCE®KPONTP29KPONTP292026-09-18
00192629005433ADVANCE®KPONTP32KPONTP322026-09-18
00192629005440ADVANCE®KPONTP35KPONTP352026-09-18
00192629005457ADVANCE®KPONTP38KPONTP382026-09-18
00192629005464ADVANCE®KPONTP41KPONTP412026-09-18
00192629005488ADVANCE®KPON32STKPON32ST2026-09-18
00192629005495ADVANCE®KPON35STKPON35ST2026-09-18
00192629005501ADVANCEKPON38SPKPON38SP2026-09-18
00192629005518ADVANCEKPON41SPKPON41SP2026-09-18
00192629005549ADVANCE®KPRC25HIKPRC25HI2026-09-18
00192629005556ADVANCE®KPRC25LOKPRC25LO2026-09-18
00192629005563ADVANCE®KPRC28HIKPRC28HI2026-09-18
00192629005570ADVANCE®KPRC28LOKPRC28LO2026-09-18
00192629082854EVOLUTIONETPKN1SLETPKN1SL2026-09-18
00192629082861EVOLUTIONETPKN2SLETPKN2SL2026-09-18
00192629082878EVOLUTIONETPKN2PLETPKN2PL2026-09-18
00192629082885EVOLUTIONETPKN3SLETPKN3SL2026-09-18
00192629082892EVOLUTIONETPKN4SLETPKN4SL2026-09-18
00192629082908EVOLUTIONETPKN5SLETPKN5SL2026-09-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840097536729Identity CR KA 3DP PorousRestor3d, Inc.MBH2026-09-25
00840097536736Identity CR KA 3DP PorousRestor3d, Inc.MBH2026-09-25
00840097536743Identity CR KA 3DP PorousRestor3d, Inc.MBH2026-09-25
00840097536750Identity CR KA 3DP PorousRestor3d, Inc.MBH2026-09-25
00840097536767Identity CR KA 3DP PorousRestor3d, Inc.MBH2026-09-25
00840097536774Identity CR KA 3DP PorousRestor3d, Inc.MBH2026-09-25
00840097536804Identity CR KA 3DP PorousRestor3d, Inc.MBH2026-09-25
00840097536811Identity CR KA 3DP PorousRestor3d, Inc.MBH2026-09-25
E31442411410SignatureMaterialise NVMBH2026-09-24
E31442422415SignatureMaterialise NVMBH2026-09-24
E31442422450SignatureMaterialise NVMBH2026-09-24
E31442422451SignatureMaterialise NVMBH2026-09-24
E31442422452SignatureMaterialise NVMBH2026-09-24
E31442422453SignatureMaterialise NVMBH2026-09-24
E31442422455SignatureMaterialise NVMBH2026-09-24
E31442422456SignatureMaterialise NVMBH2026-09-24
E31442422457SignatureMaterialise NVMBH2026-09-24
E31442422458SignatureMaterialise NVMBH2026-09-24
E31442422460SignatureMaterialise NVMBH2026-09-24
E31442422461SignatureMaterialise NVMBH2026-09-24
E31442422462SignatureMaterialise NVMBH2026-09-24
E31442422463SignatureMaterialise NVMBH2026-09-24
E31442422465SignatureMaterialise NVMBH2026-09-24
E31442422466SignatureMaterialise NVMBH2026-09-24
E31442422467SignatureMaterialise NVMBH2026-09-24
E31442422468SignatureMaterialise NVMBH2026-09-24
E31442422470SignatureMaterialise NVMBH2026-09-24
E31442422471SignatureMaterialise NVMBH2026-09-24
E31442422472SignatureMaterialise NVMBH2026-09-24
E31442422473SignatureMaterialise NVMBH2026-09-24