FDA.reportPublic FDA data

Evolution

Primary DI
M684E3500CN61
Brand
Evolution
Company
Microport Orthopedics Inc.
Model
E3500CN6
Catalog number
E3500CN6
Device description
EVOLUTION REV CONE TRIAL SIZE 6
Published
2024-08-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/PolymerOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K233507000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K233507000EVOLUTION® Tibial ConesMicroport Orthopedics, Inc.2024-01-18MBH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00192629408517PrimaryGS10
M684E3500CN61SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00192629408517001926294085171926294085170192629408517

GMDN Terms#

Term, Definition table
TermDefinition
Joint prosthesis implantation kit, reusableA collection of surgical instruments used for cutting and forming bone to allow the implantation of a joint prosthesis. The instruments include various metallic and/or plastic reusable devices (e.g., retractors, rods, clamps, drills, pins, saws, guides, cutting blocks) that are specific to the joint of application (e.g., hip, knee, shoulder, ankle, or elbow); the implant(s) is not included. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

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
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00192629087255ProfemurPHAC1202PHAC12022026-05-14
00192629087262ProfemurPHAC1204PHAC12042026-05-14
00192629087279ProfemurPHAC1212PHAC12122026-05-14
00192629087286ProfemurPHAC1214PHAC12142026-05-14
00192629087293ProfemurPHAC1222PHAC12222026-05-14
00192629087309ProfemurPHAC1224PHAC12242026-05-14
00192629087316ProfemurPHAC1232PHAC12322026-05-14
00192629087323ProfemurPHAC1234PHAC12342026-05-14
00192629087330ProfemurPHAC1242PHAC12422026-05-14
00192629087347ProfemurPHAC1244PHAC12442026-05-14
00192629087354ProfemurPHAC1252PHAC12522026-05-14
00192629324077ProphecyPNV08601PNV086012021-05-20
00192629324084ProphecyPNV08602PNV086022021-05-20
00192629324091ProphecyPNV08603PNV086032021-05-20
00192629324107ProphecyPNV08604PNV086042021-05-20
00192629324114ProphecyPNV08605PNV086052021-05-20
00192629324121ProphecyPNV08606PNV086062021-05-20
00192629324138ProphecyPNV08607PNV086072021-05-20
00192629324145ProphecyPNV08608PNV086082021-05-20
00192629324152ProphecyPNV08609PNV086092021-05-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800017269726EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-05-21
08800017269733EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-05-21
08800017269740EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-05-21
08800017269757EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-05-21
08800017269764EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-05-21
08800017269771EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-05-21
08800017269788EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-05-21
08800017269795EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-05-21
08800017260853EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017260860EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017260877EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017260884EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017260891EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017260907EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017260914EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017260921EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017260938EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017260945EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017260952EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017260969EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017260976EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017260983EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017260990EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017261003EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017261010EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017261027EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017261034EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017261041EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262178EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262185EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10