FDA.reportPublic FDA data

Persona® The Personalized Knee®

Primary DI
00889024646438
Brand
Persona® The Personalized Knee®
Company
Zimmer, Inc.
Model
42-5903-080-00
Catalog number
42-5903-080-00
Published
2024-05-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JWHPROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
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
JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/PolymerOrthopedic2
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
K240299000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K240299000Persona the Personalized Knee System (Persona OsseoTi 3-Peg Patella)Zimmer, Inc.2024-04-26MBH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00889024646438PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00889024646438008890246464388890246464380889024646438

Device Sizes#

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

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

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

Regulatory Flags#

DUNS number
056038268
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00889024713505G7® TM Acetabular System1200013321200013322026-11-03
00889024713512G7® TM Acetabular System7574000427574000422026-11-03
00889024713529G7® TM Acetabular System7574000447574000442026-11-03
00889024713536G7® TM Acetabular System7574000467574000462026-11-03
00889024713543G7® TM Acetabular System7574000487574000482026-11-03
00889024713550G7® TM Acetabular System7574000507574000502026-11-03
00889024713567G7® TM Acetabular System7574000527574000522026-11-03
00889024713574G7® TM Acetabular System7574000547574000542026-11-03
00889024713581G7® TM Acetabular System7574000567574000562026-11-03
00889024713598G7® TM Acetabular System7574000587574000582026-11-03
00889024713604G7® TM Acetabular System7574000607574000602026-11-03
00889024713611G7® TM Acetabular System7574000627574000622026-11-03
00889024713628G7® TM Acetabular System7574000647574000642026-11-03
00889024713635G7® TM Acetabular System7574000667574000662026-11-03
00889024713642G7® TM Acetabular System7574000687574000682026-11-03
00889024713659G7® TM Acetabular System7574000707574000702026-11-03
00889024713666G7® TM Acetabular System7574000727574000722026-11-03
00889024713673G7® TM Acetabular System7574000747574000742026-11-03
00889024713680G7® TM Acetabular System7574000767574000762026-11-03
00889024713697G7® TM Acetabular System7574000787574000782026-11-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800017265438EXULT Tibial InsertCorentec Co., LtdJWH2026-11-05
08800017265445EXULT Tibial InsertCorentec Co., LtdJWH2026-11-05
00192629475007EVOLUTIONMicroport Orthopedics Inc.JWH2026-11-03
00192629475014EVOLUTIONMicroport Orthopedics Inc.JWH2026-11-03
00192629475021EVOLUTIONMicroport Orthopedics Inc.JWH2026-11-03
00192629475038EVOLUTIONMicroport Orthopedics Inc.JWH2026-11-03
00192629475045EVOLUTIONMicroport Orthopedics Inc.JWH2026-11-03
00192629475052EVOLUTIONMicroport Orthopedics Inc.JWH2026-11-03
00192629475069EVOLUTIONMicroport Orthopedics Inc.JWH2026-11-03
00192629475076EVOLUTIONMicroport Orthopedics Inc.JWH2026-11-03
00192629475083EVOLUTIONMicroport Orthopedics Inc.JWH2026-11-03
00192629475090EVOLUTIONMicroport Orthopedics Inc.JWH2026-11-03
00192629475106EVOLUTIONMicroport Orthopedics Inc.JWH2026-11-03
00192629475113EVOLUTIONMicroport Orthopedics Inc.JWH2026-11-03
00192629475120EVOLUTIONMicroport Orthopedics Inc.JWH2026-11-03
00192629475137EVOLUTIONMicroport Orthopedics Inc.JWH2026-11-03
00192629475144EVOLUTIONMicroport Orthopedics Inc.JWH2026-11-03
00192629475151EVOLUTIONMicroport Orthopedics Inc.JWH2026-11-03
00192629475168EVOLUTIONMicroport Orthopedics Inc.JWH2026-11-03
00192629475175EVOLUTIONMicroport Orthopedics Inc.JWH2026-11-03
00192629475182EVOLUTIONMicroport Orthopedics Inc.JWH2026-11-03
00192629475199EVOLUTIONMicroport Orthopedics Inc.JWH2026-11-03
00192629475205EVOLUTIONMicroport Orthopedics Inc.JWH2026-11-03
00192629475212EVOLUTIONMicroport Orthopedics Inc.JWH2026-11-03
00192629475229EVOLUTIONMicroport Orthopedics Inc.JWH2026-11-03
00192629475236EVOLUTIONMicroport Orthopedics Inc.JWH2026-11-03
00192629475243EVOLUTIONMicroport Orthopedics Inc.JWH2026-11-03
00192629475250EVOLUTIONMicroport Orthopedics Inc.JWH2026-11-03
00192629475267EVOLUTIONMicroport Orthopedics Inc.JWH2026-11-03
00192629475274EVOLUTIONMicroport Orthopedics Inc.JWH2026-11-03