FDA.reportPublic FDA data

Evolution

Primary DI
EFSRN5PL
Brand
Evolution
Company
Microport Orthopedics Inc.
Model
EFSRN5PL
Catalog number
EFSRN5PL
Device description
EVOLUTION®MP FEM CS/CR NON-POR SIZE 5 PRIMARY LEFT
Published
2015-10-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HRYProsthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HRYProsthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/PolymerOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
EFSRN5PLDirect MarkingHIBCC0
M684EFSRN5PL1PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Uncoated knee femur prosthesis, metallicAn implantable device designed to replace the femoral condyles (femoral component) during primary bicondylar replacement of the knee joint, femoral bone resection, or to replace a dysfunctional knee prosthesis (revision); it is made of metal [e.g., cobalt-chrome (Co-Cr), cobalt-chrome-molybdenum (Co-Cr-Mo), titanium (Ti)] and is not coated with a material intended to improve fixation and stability by promoting bone ingrowth. The device is designed to articulate with tibial and, if required, patellar prosthetic components of the knee joint and its implantation is intended to be performed with bone cement.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
079118736
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M684PNV123741ProphecyPNV12374PNV123742026-02-03
M684PNV123751ProphecyPNV12375PNV123752026-02-03
M684PNV123761ProphecyPNV12376PNV123762026-02-03
M684PNV123771ProphecyPNV12377PNV123772026-02-03
M684PNV123781ProphecyPNV12378PNV123782026-02-03
M684PNV123791ProphecyPNV12379PNV123792026-02-03
M684PNV123801ProphecyPNV12380PNV123802026-02-03
M684PNV123811ProphecyPNV12381PNV123812026-02-03
M684PNV123821ProphecyPNV12382PNV123822026-02-03
M684PNV123831ProphecyPNV12383PNV123832026-02-03
M684PNV123841ProphecyPNV12384PNV123842026-02-03
M684PNV123851ProphecyPNV12385PNV123852026-02-03
M684PNV123861ProphecyPNV12386PNV123862026-02-03
M684PNV123871ProphecyPNV12387PNV123872026-02-03
M684PNV123881ProphecyPNV12388PNV123882026-02-03
M684PNV123891ProphecyPNV12389PNV123892026-02-03
M684PNV123901ProphecyPNV12390PNV123902026-02-03
M684PNV123911ProphecyPNV12391PNV123912026-02-03
M684PNV123921ProphecyPNV12392PNV123922026-02-03
M684PNV123931ProphecyPNV12393PNV123932026-02-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00811767027779FREEDOM PARTIAL KNEEMAXX ORTHOPEDICS, INC.HRY2025-07-31
00811767027786FREEDOM PARTIAL KNEEMAXX ORTHOPEDICS, INC.HRY2025-07-31
00811767027793FREEDOM PARTIAL KNEEMAXX ORTHOPEDICS, INC.HRY2025-07-31
00811767027809FREEDOM PARTIAL KNEEMAXX ORTHOPEDICS, INC.HRY2025-07-31
08033390281751PHYSICA POROUS CR - CoCrMo + PoroTiLIMACORPORATE SPAHRY2025-07-09
08033390281775PHYSICA POROUS CR - CoCrMo + PoroTiLIMACORPORATE SPAHRY2025-07-09
08033390281782PHYSICA POROUS CR - CoCrMo + PoroTiLIMACORPORATE SPAHRY2025-07-09
08033390281799PHYSICA POROUS CR - CoCrMo + PoroTiLIMACORPORATE SPAHRY2025-07-09
08033390281904PHYSICA POROUS CR - CoCrMo + PoroTiLIMACORPORATE SPAHRY2025-07-09
08033390281911PHYSICA POROUS CR - CoCrMo + PoroTiLIMACORPORATE SPAHRY2025-07-09
08033390281928PHYSICA POROUS CR - CoCrMo + PoroTiLIMACORPORATE SPAHRY2025-07-09
08033390281935PHYSICA POROUS CR - CoCrMo + PoroTiLIMACORPORATE SPAHRY2025-07-09
08033390281942PHYSICA POROUS CR - CoCrMo + PoroTiLIMACORPORATE SPAHRY2025-07-09
08033390281959PHYSICA POROUS CR - CoCrMo + PoroTiLIMACORPORATE SPAHRY2025-07-09
08033390281966PHYSICA POROUS CR - CoCrMo + PoroTiLIMACORPORATE SPAHRY2025-07-09
08033390281973PHYSICA POROUS CR - CoCrMo + PoroTiLIMACORPORATE SPAHRY2025-07-09
08033390281980PHYSICA POROUS CR - CoCrMo + PoroTiLIMACORPORATE SPAHRY2025-07-09
08033390281997PHYSICA POROUS CR - CoCrMo + PoroTiLIMACORPORATE SPAHRY2025-07-09
08033390282000PHYSICA POROUS CR - CoCrMo + PoroTiLIMACORPORATE SPAHRY2025-07-09
08033390282024PHYSICA POROUS CR - CoCrMo + PoroTiLIMACORPORATE SPAHRY2025-07-09
08033390282048PHYSICA POROUS CR - CoCrMo + PoroTiLIMACORPORATE SPAHRY2025-07-09
08033390282055PHYSICA POROUS CR - CoCrMo + PoroTiLIMACORPORATE SPAHRY2025-07-09
08033390282062PHYSICA POROUS CR - CoCrMo + PoroTiLIMACORPORATE SPAHRY2025-07-09
08033390282079PHYSICA POROUS CR - CoCrMo + PoroTiLIMACORPORATE SPAHRY2025-07-09
04026575448630LinkSymphoKneeWALDEMAR LINK GmbH & Co. KGHRY2025-04-02
04026575448647LinkSymphoKneeWALDEMAR LINK GmbH & Co. KGHRY2025-04-02
00885556921388LegionSmith & Nephew, Inc.HRY2024-11-26
00885556921395LegionSmith & Nephew, Inc.HRY2024-11-26
00885556921401LegionSmith & Nephew, Inc.HRY2024-11-26
00885556921418LegionSmith & Nephew, Inc.HRY2024-11-26