FDA.reportPublic FDA data

P.F.C. SIGMA

Primary DI
10603295217152
Brand
P.F.C. SIGMA
Company
DEPUY (IRELAND)
Model
86-6448
Catalog number
866448
Device description
P.F.C. SIGMA MODULAR FLUTED ROD 22mm x 150mm
Published
2015-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Contact Domains#

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
K241000000
K882234000
K952830000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K241000000ATTUNE™ Revision Knee System; DePuy Knee Prosthesis System Universal Stem Extensions and Universal Femoral Metaphyseal Sleeves; DePuy Sigma PS Femoral Components; DePuy Sigma Cruciate Retaining (C/R) Porocoat Femoral Components; S-ROM™ NOILES™ Rotating Hinge Knee System; DePuy P.F.C. ™ SIGMA™ Total Knee System; DePuy SIGMA™ Total Knee System;Depuy Ireland UC2024-07-11JWH
K882234000JOHNSON & JOHNSON MODULAR TOTAL KNEE PROSTHESISJohnson & Johnson Professionals, Inc.1988-10-20JWH
K952830000DARWIN KNEE SYSTEM (TC3)Johnson & Johnson Professionals, Inc.1996-01-18JWH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10603295217152PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1060329521715210603295217152

GMDN Terms#

Term, Definition table
TermDefinition
Knee femur stem prosthesisA sterile device designed to provide additional stability for an implanted knee femur prosthesis by extending the attachment of the prosthesis from the distal femur into the midshaft of the bone. It is typically a shaft-like device made of metal [e.g., cobalt-chrome (Co-Cr)] and is often used in prosthesis revision to compensate for bone loss.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)255-2500xx@xx.xx

Regulatory Flags#

DUNS number
989365556
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10603295168324SMARTSET3092-02030920202015-09-24
10603295168331SMARTSET3092-04030920402015-09-24
10603295168614NA3312-04033120402015-09-24
10603295168621NA3322-02033220202015-09-24
10603295168638NA3332-04033320402015-09-24
10603295005438GLOBAL AP1130-02-0001130020002015-09-24
10603295218289S-ROM87-34358734352015-09-24
10603295218470S-ROM87-35568735562015-09-24
10603295218487S-ROM87-35578735572015-09-24
10603295218951S-ROM87-59878759872015-09-24
10603295519935VELYS4515-70-2264515702262021-05-26
10603295519430VELYS4515-70-1024515701022021-05-13
10603295519492VELYS4515-70-1014515701012021-05-13
10603295519515VELYS4515-70-1004515701002021-05-13
10603295519379VELYS4515-70-1074515701072021-05-07
10603295519461VELYS4515-70-1054515701052021-05-07
10603295519478VELYS4515-70-1064515701062021-05-07
10603295519485VELYS4515-70-1094515701092021-05-07
10603295170655S-ROM52-15035215032015-09-24
10603295170662S-ROM52-15045215042015-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00192629298675ProphecyMicroport Orthopedics Inc.JWH2020-09-25
00192629298682ProphecyMicroport Orthopedics Inc.JWH2020-09-25
00192629298699ProphecyMicroport Orthopedics Inc.JWH2020-09-25
00192629298705ProphecyMicroport Orthopedics Inc.JWH2020-09-25
00192629298712ProphecyMicroport Orthopedics Inc.JWH2020-09-25
00192629298729ProphecyMicroport Orthopedics Inc.JWH2020-09-25
00192629298736ProphecyMicroport Orthopedics Inc.JWH2020-09-25
00192629298743ProphecyMicroport Orthopedics Inc.JWH2020-09-25
00192629298750ProphecyMicroport Orthopedics Inc.JWH2020-09-25
00192629298767ProphecyMicroport Orthopedics Inc.JWH2020-09-25
00192629298774ProphecyMicroport Orthopedics Inc.JWH2020-09-25
00192629298781ProphecyMicroport Orthopedics Inc.JWH2020-09-25
00192629298798ProphecyMicroport Orthopedics Inc.JWH2020-09-25
00192629298804ProphecyMicroport Orthopedics Inc.JWH2020-09-25
00192629298811ProphecyMicroport Orthopedics Inc.JWH2020-09-25
00192629298828ProphecyMicroport Orthopedics Inc.JWH2020-09-25
00192629298835ProphecyMicroport Orthopedics Inc.JWH2020-09-25
00192629298842ProphecyMicroport Orthopedics Inc.JWH2020-09-25
00192629298859ProphecyMicroport Orthopedics Inc.JWH2020-09-25
00192629298866ProphecyMicroport Orthopedics Inc.JWH2020-09-25
00192629298873ProphecyMicroport Orthopedics Inc.JWH2020-09-25
00192629298880ProphecyMicroport Orthopedics Inc.JWH2020-09-25
00192629298897ProphecyMicroport Orthopedics Inc.JWH2020-09-25
00192629298903ProphecyMicroport Orthopedics Inc.JWH2020-09-25
00192629298910ProphecyMicroport Orthopedics Inc.JWH2020-09-25
00192629298927ProphecyMicroport Orthopedics Inc.JWH2020-09-25
00192629298934ProphecyMicroport Orthopedics Inc.JWH2020-09-25
00192629298941ProphecyMicroport Orthopedics Inc.JWH2020-09-25
00192629298958ProphecyMicroport Orthopedics Inc.JWH2020-09-25
00192629298965ProphecyMicroport Orthopedics Inc.JWH2020-09-25