FDA.reportPublic FDA data

Femoral Component

Primary DI
EPIS51117PF0
Brand
Femoral Component
Company
Episurf Operations AB
Model
2xD17
Catalog number
51117PF
Published
2023-07-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
KRRProsthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KRRProsthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/PolymerOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K221048000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K221048000Episealer Patellofemoral SystemEpisurf Medical, Inc.2022-12-23KRR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
EPIS51117PF0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Patellofemoral joint prosthesisA sterile implantable device designed to replace the patellofemoral articulating surface of the knee to treat isolated patellofemoral disease, typically osteoarthritis. The device is made of metal (e.g., oxidized zirconium alloy) and is not coated with a material intended to improve fixation and stability by promoting bone ingrowth; it may include fixation devices (e.g., pegs) for implantation which is intended to be performed with bone cement.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
352393402
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
EPIS960010EpisurfView1.02026-03-17
EPIS18100PF0Episealer Knee Revision GuideFirst version18100PF2023-07-24
EPIS31120PF0Femoral ComponentD2031120PF2023-07-24
EPIS31125PF0Femoral ComponentD2531125PF2023-07-24
EPIS31129PF0Femoral ComponentD2931129PF2023-07-24
EPIS32120PF0Femoral EpidrillD2032120PF2023-07-24
EPIS32125PF0Femoral EpidrillD2532125PF2023-07-24
EPIS32129PF0Femoral EpidrillD2932129PF2023-07-24
EPIS33120PF0Femoral Drilling SocketD2033120PF2023-07-24
EPIS33125PF0Femoral Drilling SocketD2533125PF2023-07-24
EPIS33129PF0Femoral Drilling SocketD2933129PF2023-07-24
EPIS33420PF0Femoral Adjustment SocketD2033420PF2023-07-24
EPIS33425PF0Femoral Adjustment SocketD2533425PF2023-07-24
EPIS33429PF0Femoral Adjustment SocketD2933429PF2023-07-24
EPIS33720PF0Femoral EpiguideD2033720PF2023-07-24
EPIS33725PF0Femoral EpiguideD2533725PF2023-07-24
EPIS33729PF0Femoral EpiguideD2933729PF2023-07-24
EPIS34120PF0Femoral EpidummyD2034120PF2023-07-24
EPIS34125PF0Femoral EpidummyD2534125PF2023-07-24
EPIS34129PF0Femoral EpidummyD2934129PF2023-07-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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07613327127478INSTRUMENTHowmedica Osteonics Corp.KRR2017-11-24
07613327127492INSTRUMENTHowmedica Osteonics Corp.KRR2017-11-24
07613327127508INSTRUMENTHowmedica Osteonics Corp.KRR2017-11-24
07613327127515INSTRUMENTHowmedica Osteonics Corp.KRR2017-11-24
07613327127522INSTRUMENTHowmedica Osteonics Corp.KRR2017-11-24
07613327127539INSTRUMENTHowmedica Osteonics Corp.KRR2017-11-24
07613327127560INSTRUMENTHowmedica Osteonics Corp.KRR2017-11-24
07613327049305AvonHowmedica Osteonics Corp.KRR2017-06-19
07613154557431INSTRUMENTHowmedica Osteonics Corp.KRR2016-09-24
07613327051094INSTRUMENTHowmedica Osteonics Corp.KRR2016-09-24
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07613327051124INSTRUMENTHowmedica Osteonics Corp.KRR2016-09-24
07613327051131INSTRUMENTHowmedica Osteonics Corp.KRR2016-09-24
07613327051148INSTRUMENTHowmedica Osteonics Corp.KRR2016-09-24
07613327051155INSTRUMENTHowmedica Osteonics Corp.KRR2016-09-24
07613327051162INSTRUMENTHowmedica Osteonics Corp.KRR2016-09-24
07613327051179INSTRUMENTHowmedica Osteonics Corp.KRR2016-09-24
07613327051186INSTRUMENTHowmedica Osteonics Corp.KRR2016-09-24
07613327051193INSTRUMENTHowmedica Osteonics Corp.KRR2016-09-24
07613327051209INSTRUMENTHowmedica Osteonics Corp.KRR2016-09-24
07613327051216INSTRUMENTHowmedica Osteonics Corp.KRR2016-09-24
07613327051223INSTRUMENTHowmedica Osteonics Corp.KRR2016-09-24
07613327051230INSTRUMENTHowmedica Osteonics Corp.KRR2016-09-24
07613327051247INSTRUMENTHowmedica Osteonics Corp.KRR2016-09-24
07613327127546INSTRUMENTHowmedica Osteonics Corp.KRR2016-09-24
07613327127553INSTRUMENTHowmedica Osteonics Corp.KRR2016-09-24