FDA.reportPublic FDA data

Vivacit-E®

Primary DI
00889024517639
Brand
Vivacit-E®
Company
Zimmer, Inc.
Model
00-5842-092-14
Catalog number
00-5842-092-14
Published
2018-09-14
Public version status
New
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
HSXPROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER
OIYProsthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer + additive/metal/polymer + additive

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HSXProsthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/PolymerOrthopedic2
OIYProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + AdditiveOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K122529000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K122529000ZIMMER UNICOMPARTMENTAL KNEE SYSTEM VIVACIT-E ARTICULAR SURFACEZimmer, Inc.2012-11-16HSX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00889024517639PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00889024517639008890245176398890245176390889024517639

GMDN Terms#

Term, Definition table
TermDefinition
Unicondylar knee insertA sterile implantable device designed to articulate the femoral and tibial components of a knee joint prosthesis during primary or revision unicompartmental knee joint replacement. It is a one-piece contoured device typically made of polyethylene (PE).

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Height14Millimeter

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
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
00193982533663ACTIFY 3DGLOBUS MEDICAL, INC.OIY2026-08-14
00193982533670ACTIFY 3DGLOBUS MEDICAL, INC.OIY2026-08-14
00193982533687ACTIFY 3DGLOBUS MEDICAL, INC.OIY2026-08-14
00193982533694ACTIFY 3DGLOBUS MEDICAL, INC.OIY2026-08-14
00193982533700ACTIFY 3DGLOBUS MEDICAL, INC.OIY2026-08-14
00193982533717ACTIFY 3DGLOBUS MEDICAL, INC.OIY2026-08-14
00193982533724ACTIFY 3DGLOBUS MEDICAL, INC.OIY2026-08-14
00193982533731ACTIFY 3DGLOBUS MEDICAL, INC.OIY2026-08-14
00193982533748ACTIFY 3DGLOBUS MEDICAL, INC.OIY2026-08-14
00193982533861ACTIFY 3DGLOBUS MEDICAL, INC.OIY2026-08-14
00193982533878ACTIFY 3DGLOBUS MEDICAL, INC.OIY2026-08-14
00193982533885ACTIFY 3DGLOBUS MEDICAL, INC.OIY2026-08-14
00193982533892ACTIFY 3DGLOBUS MEDICAL, INC.OIY2026-08-14
00193982533908ACTIFY 3DGLOBUS MEDICAL, INC.OIY2026-08-14
00193982533915ACTIFY 3DGLOBUS MEDICAL, INC.OIY2026-08-14
00193982533922ACTIFY 3DGLOBUS MEDICAL, INC.OIY2026-08-14
00193982533939ACTIFY 3DGLOBUS MEDICAL, INC.OIY2026-08-14
00193982533946ACTIFY 3DGLOBUS MEDICAL, INC.OIY2026-08-14
00193982677428ACTIFY 3DGLOBUS MEDICAL, INC.OIY2026-08-14
00193982677435ACTIFY 3DGLOBUS MEDICAL, INC.OIY2026-08-14
00193982677442ACTIFY 3DGLOBUS MEDICAL, INC.OIY2026-08-14
00193982677459ACTIFY 3DGLOBUS MEDICAL, INC.OIY2026-08-14
00840097536552iTotal Identity CR 3DP PorousRestor3d, Inc.OIY2026-07-31
00840097536569iTotal Identity CR 3DP PorousRestor3d, Inc.OIY2026-07-31
00840097536576iTotal Identity CR 3DP PorousRestor3d, Inc.OIY2026-07-31
00840097536583iTotal Identity CR 3DP PorousRestor3d, Inc.OIY2026-07-31
00840097536590iTotal Identity CR 3DP PorousRestor3d, Inc.OIY2026-07-31
00843575106445MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.OIY2026-05-29
00843575106452MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.OIY2026-05-29
00843575106469MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.OIY2026-05-29