FDA.reportPublic FDA data

Gender Solutions®

Primary DI
00889024205840
Brand
Gender Solutions®
Company
Zimmer, Inc.
Model
00-5926-012-02
Catalog number
00-5926-012-02
Published
2017-10-09
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
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
K070695000
K173057000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K070695000ZIMMER PATELLOFEMORAL JOINT PROSTHESISZimmer, Inc.2007-06-07KRR
K173057000Zimmer Knee Joint Replacement Prostheses MR LabelingZimmer, Inc.2018-03-29JWH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00889024205840PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00889024205840008890242058408890242058400889024205840

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)348-2759zimmer.consumerrelations@zimmerbiomet.com

Regulatory Flags#

DUNS number
056038268
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00889024701670Identity® Shoulder System1200046571200046572026-06-09
00889024707382Persona Tensor Sizer Arm – LongSSI008513SSI0085132026-05-29
00889024707399Persona Tensor Sizer Arm – StdSSI008567SSI0085672026-05-29
00889024707405Persona Tensor Sizer BodySSI008566SSI0085662026-05-29
00889024081024XtraFix® Large External Fixation System00-5207-024-3000-5207-024-302016-08-09
00889024081055XtraFix® Large External Fixation System00-5207-032-3000-5207-032-302016-07-27
00889024081062XtraFix® Large External Fixation System00-5207-040-1000-5207-040-102016-07-28
00889024081079XtraFix® Large External Fixation System00-5207-040-7000-5207-040-702016-07-28
00889024081086XtraFix® Large External Fixation System00-5207-045-1000-5207-045-102016-07-28
00889024081093XtraFix® Large External Fixation System00-5210-009-0100-5210-009-012016-09-28
00889024081109XtraFix® Large External Fixation System00-5210-009-0200-5210-009-022016-09-28
00889024081147XtraFix® Large External Fixation System00-5210-019-0100-5210-019-012016-09-28
00889024081154XtraFix® Large External Fixation System00-5210-029-0100-5210-029-012016-09-28
00889024081178XtraFix® Large External Fixation System00-5210-040-0000-5210-040-002016-09-28
00889024081185XtraFix® Large External Fixation System00-5210-040-0100-5210-040-012016-09-28
00889024081192XtraFix® Large External Fixation System00-5210-040-0200-5210-040-022016-09-28
00889024081208XtraFix® Large External Fixation System00-5210-040-0300-5210-040-032016-09-28
00889024081215XtraFix® Large External Fixation System00-5210-040-0400-5210-040-042016-09-28
00889024081239XtraFix® Large External Fixation System00-5210-040-0600-5210-040-062016-09-28
00889024081253XtraFix® Large External Fixation System00-5210-050-0100-5210-050-012016-09-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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07613327127423INSTRUMENTHowmedica Osteonics Corp.KRR2017-11-24
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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
07613327051100INSTRUMENTHowmedica Osteonics Corp.KRR2016-09-24
07613327051117INSTRUMENTHowmedica Osteonics Corp.KRR2016-09-24
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