FDA.reportPublic FDA data

NexGen

Primary DI
00889024518315
Brand
NexGen
Company
Zimmer, Inc.
Model
SSI004648
Catalog number
SSI004648
Published
2018-08-23
Public version status
Update
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
KROProsthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/PolymerOrthopedic2
KROProsthesis, Knee, Femorotibial, Constrained, Cemented, Metal/PolymerOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K152494000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K152494000Zimmer NexGen Complete Knee Solution Tibial and Femoral AugmentsZimmer, Inc.2015-11-25JWH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00889024518315PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00889024518315008890245183158890245183150889024518315

GMDN Terms#

Term, Definition table
TermDefinition
Knee tibia prosthesis trialA copy of a final tibia 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 femur trial prosthesis and a patella trial prosthesis. It is typically made of metal or polymer material and includes tibial base plate trials, tibial spacer trials, tibial insert trials, tibial stem trials, tibial wedge/augment trials, and guide pin trials. This is a reusable device intended to be sterilized prior to use.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Height10Millimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
1 (800) 343-9500customerservice@zimmerbiomet.com

Regulatory Flags#

DUNS number
056038268
Device count
1
Serial number
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00889024699854IDENTITY Humeral1200017901200017902026-10-21
00889024699861IDENTITY Humeral1200017911200017912026-10-21
00889024699878IDENTITY Humeral1200017921200017922026-10-21
00889024699885IDENTITY Humeral1200017931200017932026-10-21
00889024699892IDENTITY Humeral1200017941200017942026-10-21
00889024699908IDENTITY Humeral1200017951200017952026-10-21
00889024699915Comprehensive Humeral1200017981200017982026-10-21
00889024699922Identity Humeral1200017991200017992026-10-21
00889024699939N/A1200020041200020042026-10-20
00889024699946N/A1200020051200020052026-10-20
00889024699953Alliance Glenoid, Identity Humeral1200060141200060142026-10-20
00889024709164CANNULATED 1.5MM HEX DRIVERSSI004137SSI0041372026-10-19
00889024709171CANNULATED 2.0MM HEX DRIVERSSI004138SSI0041382026-10-19
00889024715196T6 Driver 127mm AO QCSSI008712SSI0087122026-10-19
00889024715202T8 Driver 127mm AO QCSSI008713SSI0087132026-10-19
00889024715295Persona Extended V/V Guide Assembly (MFS)SSI008760SSI0087602026-10-19
00889024715271Affixus®2113060432113060432026-10-06
00889024707160G7® Vivacit-E®30104005301040052026-09-30
00889024707184G7® Vivacit-E®30103603301036032026-09-30
00889024707207G7® Vivacit-E®30104407301044072026-09-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05056139247750Unity Total Knee SystemCORIN LTDJWH2026-10-23
05056139247804Unity Total Knee SystemCORIN LTDJWH2026-10-23
05056139247811Unity Total Knee SystemCORIN LTDJWH2026-10-23
05056139247828Unity Total Knee SystemCORIN LTDJWH2026-10-23
05056139247835Unity Total Knee SystemCORIN LTDJWH2026-10-23
05056139247941Unity Total Knee SystemCORIN LTDJWH2026-10-23
05056139247958Unity Total Knee SystemCORIN LTDJWH2026-10-23
05056139247965Unity Total Knee SystemCORIN LTDJWH2026-10-23
05056139247972Unity Total Knee SystemCORIN LTDJWH2026-10-23
05056139247989Unity Total Knee SystemCORIN LTDJWH2026-10-23
05056139248047Unity Total Knee SystemCORIN LTDJWH2026-10-23
05056139248054Unity Total Knee SystemCORIN LTDJWH2026-10-23
05056139248061Unity Total Knee SystemCORIN LTDJWH2026-10-23
05056139248078Unity Total Knee SystemCORIN LTDJWH2026-10-23
05056139248085Unity Total Knee SystemCORIN LTDJWH2026-10-23
05056139248146Unity Total Knee SystemCORIN LTDJWH2026-10-23
05056139248153Unity Total Knee SystemCORIN LTDJWH2026-10-23
05056139248160Unity Total Knee SystemCORIN LTDJWH2026-10-23
05056139248177Unity Total Knee SystemCORIN LTDJWH2026-10-23
05056139248184Unity Total Knee SystemCORIN LTDJWH2026-10-23
05056139248597Unity Total Knee SystemCORIN LTDJWH2026-10-23
05056139249013Unity Total Knee SystemCORIN LTDJWH2026-10-23
05056139249020Unity Total Knee SystemCORIN LTDJWH2026-10-23
05056139249037Unity Total Knee SystemCORIN LTDJWH2026-10-23
05056139249044Unity Total Knee SystemCORIN LTDJWH2026-10-23
05056139249303Unity Total Knee SystemCORIN LTDJWH2026-10-23
05056139249310Unity Total Knee SystemCORIN LTDJWH2026-10-23
05056139249327Unity Total Knee SystemCORIN LTDJWH2026-10-23
05056139249334Unity Total Knee SystemCORIN LTDJWH2026-10-23
05056139249341Unity Total Knee SystemCORIN LTDJWH2026-10-23