FDA.reportPublic FDA data

Persona® Revision Knee System

Primary DI
00889024660328
Brand
Persona® Revision Knee System
Company
Zimmer, Inc.
Model
42-5746-058-01
Catalog number
42-5746-058-01
Published
2025-05-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MBHPROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER
OIYProsthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer + additive/metal/polymer + additive

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MBHProsthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/PolymerOrthopedic2
OIYProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + AdditiveOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K243724000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K243724000Persona® Revision Knee System (Persona Revision SoluTion™ Femoral Components)Zimmer, Inc.2025-03-06JWH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00889024660328PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00889024660328008890246603288890246603280889024660328

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.

Device Sizes#

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

Contacts#

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

Regulatory Flags#

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00889024702356OsseoFit00-5381-017-1100-5381-017-112026-10-28
00889024702363OsseoFit00-5381-017-1200-5381-017-122026-10-28
00889024702370OsseoFit00-5381-017-1300-5381-017-132026-10-28
00889024702387OsseoFit00-5381-017-1400-5381-017-142026-10-28
00889024702394OsseoFit00-5381-017-1500-5381-017-152026-10-28
00889024702400OsseoFit00-5381-017-1600-5381-017-162026-10-28
00889024702417OsseoFit00-5381-017-2100-5381-017-212026-10-28
00889024702424OsseoFit00-5381-017-2200-5381-017-222026-10-28
00889024702431OsseoFit00-5381-017-2300-5381-017-232026-10-28
00889024702448OsseoFit00-5381-017-2400-5381-017-242026-10-28
00889024702455OsseoFit00-5381-017-2500-5381-017-252026-10-28
00889024702462OsseoFit00-5381-017-2600-5381-017-262026-10-28
00889024702233OsseoFit00-5381-008-0500-5381-008-052026-10-27
00889024702240OsseoFit00-5381-008-0600-5381-008-062026-10-27
00889024702257OsseoFit00-5381-013-0000-5381-013-002026-10-27
00889024702264OsseoFit00-5381-013-1000-5381-013-102026-10-27
00889024702271OsseoFit00-5381-013-1100-5381-013-112026-10-27
00889024702295OsseoFit00-5381-013-1300-5381-013-132026-10-27
00889024702301OsseoFit00-5381-014-0000-5381-014-002026-10-27
00889024702318OsseoFit00-5381-014-0100-5381-014-012026-10-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05056139247750Unity Total Knee SystemCORIN LTDOIY2026-10-23
05056139247804Unity Total Knee SystemCORIN LTDOIY2026-10-23
05056139247811Unity Total Knee SystemCORIN LTDOIY2026-10-23
05056139247828Unity Total Knee SystemCORIN LTDOIY2026-10-23
05056139247835Unity Total Knee SystemCORIN LTDOIY2026-10-23
05056139247941Unity Total Knee SystemCORIN LTDOIY2026-10-23
05056139247958Unity Total Knee SystemCORIN LTDOIY2026-10-23
05056139247965Unity Total Knee SystemCORIN LTDOIY2026-10-23
05056139247972Unity Total Knee SystemCORIN LTDOIY2026-10-23
05056139247989Unity Total Knee SystemCORIN LTDOIY2026-10-23
05056139248047Unity Total Knee SystemCORIN LTDOIY2026-10-23
05056139248054Unity Total Knee SystemCORIN LTDOIY2026-10-23
05056139248061Unity Total Knee SystemCORIN LTDOIY2026-10-23
05056139248078Unity Total Knee SystemCORIN LTDOIY2026-10-23
05056139248085Unity Total Knee SystemCORIN LTDOIY2026-10-23
05056139248146Unity Total Knee SystemCORIN LTDOIY2026-10-23
05056139248153Unity Total Knee SystemCORIN LTDOIY2026-10-23
05056139248160Unity Total Knee SystemCORIN LTDOIY2026-10-23
05056139248177Unity Total Knee SystemCORIN LTDOIY2026-10-23
05056139248184Unity Total Knee SystemCORIN LTDOIY2026-10-23
05056139248597Unity Total Knee SystemCORIN LTDOIY2026-10-23
05056139249013Unity Total Knee SystemCORIN LTDOIY2026-10-23
05056139249020Unity Total Knee SystemCORIN LTDOIY2026-10-23
05056139249037Unity Total Knee SystemCORIN LTDOIY2026-10-23
05056139249044Unity Total Knee SystemCORIN LTDOIY2026-10-23
05056139249303Unity Total Knee SystemCORIN LTDOIY2026-10-23
05056139249310Unity Total Knee SystemCORIN LTDOIY2026-10-23
05056139249327Unity Total Knee SystemCORIN LTDOIY2026-10-23
05056139249334Unity Total Knee SystemCORIN LTDOIY2026-10-23
05056139249341Unity Total Knee SystemCORIN LTDOIY2026-10-23