FDA.reportPublic FDA data

Persona® Knee System

Primary DI
00889024630383
Brand
Persona® Knee System
Company
Zimmer, Inc.
Model
42-5047-074-02
Catalog number
42-5047-074-02
Published
2024-11-05
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
K123459000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K123459000ZIMMER PERSONA TM PERSONALIZED KNEE SYSTEMZimmer, Inc.2013-02-22MBH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00889024630383PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00889024630383008890246303838890246303830889024630383

GMDN Terms#

Term, Definition table
TermDefinition
Knee femur prosthesis trial, reusableA copy of a final femur prosthesis designed to be used during unicompartmental knee replacement surgery or total knee arthroplasty (TKA) to determine the correct alignment, size, and fit of the final prosthesis. It is one of a set, or a set, of graduated sizes, and may be used in conjunction with a knee tibia trial prosthesis and a patella trial prosthesis. It is typically made of metal or polymer material and includes femoral articulation trials, femoral spacer trials, femoral wedge/augment trials, anterior stop trials, stem adaptor trials, and stem trials. 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
056038268
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
00889024711464Comp Mini Humeral Tray Trial Stem AdapterSSI008664SSI0086642026-08-25
008890247114712.9 JuggerKnot Self-Punching ObturatorSSI008672SSI0086722026-08-25
008890247114882.9 JuggerKnot Self-Punching CannulaSSI008671SSI0086712026-08-25
00889024712294Pin Target AssemblySSI001470SSI0014702026-08-25
00889024712300Z1 POSTERIOR HAMMR ADPTRSSI008666SSI0086662026-08-25
00889024712317Z1 ANTERIOR HAMMR ADPTRSSI008665SSI0086652026-08-25
00889024712843PTH SHELL PSTNR ASSYSSI008611SSI0086112026-08-25
00889024712850PTH SHELL ADPTR SMLLSSI008612SSI0086122026-08-25
00889024712867PTH SHELL ADPTR LRGSSI008658SSI0086582026-08-25
00889024712874PTH BOOMSSI008680SSI0086802026-08-25
00889024712881PTH TROCARSSI008681SSI0086812026-08-25
008890247128986.5/8.0mm Countersink, Cannulated ZH QCSSI008697SSI0086972026-08-25
00889024712904RMR LONG KEYSSI008690SSI0086902026-08-25
00889024712911X BAR RMR ADPT TALLSSI008688SSI0086882026-08-25
00889024712928RMR SHORT KEYSSI008689SSI0086892026-08-25
00889024712935RMR SHORT KEY BENTSSI008691SSI0086912026-08-25
00889024712942RMR LONG KEY BENTSSI008692SSI0086922026-08-25
00889024713277Universal Uni Knee TensorSSI008695SSI0086952026-08-25
00889024713284Right Uni Knee TensorSSI008696SSI0086962026-08-25
00889024713291Left Uni Knee TensorSSI008694SSI0086942026-08-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840097536705Identity CR KARestor3d, Inc.JWH2026-09-25
00840097536705Identity CR KARestor3d, Inc.OIY2026-09-25
00840097536712Identity CR KARestor3d, Inc.OIY2026-09-25
00840097536712Identity CR KARestor3d, Inc.JWH2026-09-25
00840097536729Identity CR KA 3DP PorousRestor3d, Inc.OIY2026-09-25
00840097536729Identity CR KA 3DP PorousRestor3d, Inc.JWH2026-09-25
00840097536729Identity CR KA 3DP PorousRestor3d, Inc.MBH2026-09-25
00840097536736Identity CR KA 3DP PorousRestor3d, Inc.OIY2026-09-25
00840097536736Identity CR KA 3DP PorousRestor3d, Inc.JWH2026-09-25
00840097536736Identity CR KA 3DP PorousRestor3d, Inc.MBH2026-09-25
00840097536743Identity CR KA 3DP PorousRestor3d, Inc.OIY2026-09-25
00840097536743Identity CR KA 3DP PorousRestor3d, Inc.JWH2026-09-25
00840097536743Identity CR KA 3DP PorousRestor3d, Inc.MBH2026-09-25
00840097536750Identity CR KA 3DP PorousRestor3d, Inc.MBH2026-09-25
00840097536750Identity CR KA 3DP PorousRestor3d, Inc.OIY2026-09-25
00840097536750Identity CR KA 3DP PorousRestor3d, Inc.JWH2026-09-25
00840097536767Identity CR KA 3DP PorousRestor3d, Inc.OIY2026-09-25
00840097536767Identity CR KA 3DP PorousRestor3d, Inc.JWH2026-09-25
00840097536767Identity CR KA 3DP PorousRestor3d, Inc.MBH2026-09-25
00840097536774Identity CR KA 3DP PorousRestor3d, Inc.OIY2026-09-25
00840097536774Identity CR KA 3DP PorousRestor3d, Inc.JWH2026-09-25
00840097536774Identity CR KA 3DP PorousRestor3d, Inc.MBH2026-09-25
00840097536781Identity CR KARestor3d, Inc.OIY2026-09-25
00840097536781Identity CR KARestor3d, Inc.JWH2026-09-25
00840097536798Identity CR KARestor3d, Inc.OIY2026-09-25
00840097536798Identity CR KARestor3d, Inc.JWH2026-09-25
00840097536804Identity CR KA 3DP PorousRestor3d, Inc.OIY2026-09-25
00840097536804Identity CR KA 3DP PorousRestor3d, Inc.JWH2026-09-25
00840097536804Identity CR KA 3DP PorousRestor3d, Inc.MBH2026-09-25
00840097536811Identity CR KA 3DP PorousRestor3d, Inc.OIY2026-09-25