FDA.reportPublic FDA data

Persona®

Primary DI
00889024577695
Brand
Persona®
Company
Zimmer GmbH
Model
110040850
Catalog number
110040850
Published
2021-11-12
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
K212129000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K212129000Persona® Personalized Knee SystemZimmer Switzerland Manufacturing GmbH2021-09-28JWH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00889024577695PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00889024577695008890245776958890245776950889024577695

GMDN Terms#

Term, Definition table
TermDefinition
Joint prosthesis implantation kit, reusableA collection of surgical instruments used for cutting and forming bone to allow the implantation of a joint prosthesis. The instruments include various metallic and/or plastic reusable devices (e.g., retractors, rods, clamps, drills, pins, saws, guides, cutting blocks) that are specific to the joint of application (e.g., hip, knee, shoulder, ankle, or elbow); the implant(s) is not included. This is a reusable device.

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
488133448
Device count
1
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00887868453120Avenir®01.08000.01201.08000.0122021-02-25
00889024298521Natural Nail®47-2487-002-0047-2487-002-002015-10-21
00889024298538Natural Nail®47-2487-002-0547-2487-002-052015-10-21
00889024298545Natural Nail®47-2487-002-1047-2487-002-102015-10-21
00889024298552Natural Nail®47-2487-002-1547-2487-002-152015-10-21
00889024292512NCB®02.02261.0132024-05-03
00889024292550NCB®02.02261.1132024-05-03
00889024296558NCB®02.03156.0902024-05-03
00889024296565NCB®02.03156.0952024-05-03
00889024296572NCB®02.03156.1002024-05-03
00889024506503Affixus® Natural Nail®1100356641100356642019-03-21
00889024506510Affixus® Natural Nail®1100372371100372372019-03-21
00889024506527Affixus® Natural Nail®1100356651100356652019-03-21
00889024506534Affixus® Natural Nail®1100356661100356662019-03-21
00889024506558Affixus® Natural Nail®1100356681100356682019-03-21
00889024277038Dynesys® Top-Loading System01.03956.4502015-10-16
00889024283688Dynesys®01.03710.0062015-10-16
00889024283695Dynesys®01.03710.6452016-03-14
00889024283701Dynesys®01.03711.1002016-03-14
00889024283718Dynesys®01.03711.2002016-03-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00885556923023NASmith & Nephew, Inc.JWH2026-07-16
08800017262178EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262185EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262192EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262208EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262215EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262222EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262239EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262246EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262253EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262260EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262277EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262284EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262291EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262307EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262314EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262321EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262338EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262345EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262352EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262369EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262376EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262383EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262390EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262406EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262413EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262420EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262437EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262444EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262451EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10