FDA.reportPublic FDA data

NEXGEN® TRABECULAR METAL™

Primary DI
00889024309432
Brand
NEXGEN® TRABECULAR METAL™
Company
ZIMMER TRABECULAR METAL TECHNOLOGY INC.
Model
00-5490-033-20
Catalog number
00-5490-033-20
Published
2015-09-24
Public version status
Update
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
JWHPROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
MBHPROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K024161000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K024161000NEXGEN COMPLETE KNEE SOLUTION - TRABECULAR METAL AUGMENTSImplex Corp.2003-01-15JWH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00889024309432PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00889024309432008890243094328890243094320889024309432

Device Sizes#

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

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
793120965
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00889024310810NEXGEN®00-5887-056-0000-5887-056-002016-06-20
00889024223752TM Ardis®96-701-0107196-701-010712016-05-26
00889024223769TM Ardis®96-701-0207196-701-020712016-05-26
00889024223776TM Ardis®96-701-0307196-701-030712016-05-26
00889024223783TM Ardis®96-701-0407196-701-040712016-05-26
00889024223790TM Ardis®96-701-0507196-701-050712016-05-26
00889024223806TM Ardis®96-701-0607196-701-060712016-05-26
00889024223813TM Ardis®96-701-3100196-701-310012016-05-26
00889024316164Mergence™-S96-101-0105196-101-010512017-09-20
00889024316171Mergence™-S96-101-0106196-101-010612017-09-20
00889024316188Mergence™-S96-101-0107196-101-010712017-09-20
00889024316195Mergence™-S96-101-0108196-101-010812017-09-20
00889024316201Mergence™-S96-101-0109196-101-010912017-09-20
00889024316218Mergence™-S96-101-0110196-101-011012017-09-20
00889024316256Mergence™-S96-101-0205196-101-020512017-09-20
00889024316263Mergence™-S96-101-0206196-101-020612017-09-20
00889024316270Mergence™-S96-101-0207196-101-020712017-09-20
00889024316287Mergence™-S96-101-0208196-101-020812017-09-20
00889024316294Mergence™-S96-101-0209196-101-020912017-09-20
00889024316300Mergence™-S96-101-0210196-101-021012017-09-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00811382039348NovoKnee Total Knee SystemNovosource, LLCJWH2026-10-30
00811382039355NovoKnee Total Knee SystemNovosource, LLCJWH2026-10-30
00811382039362NovoKnee Total Knee SystemNovosource, LLCJWH2026-10-30
00811382039379NovoKnee Total Knee SystemNovosource, LLCJWH2026-10-30
00811382039386NovoKnee Total Knee SystemNovosource, LLCJWH2026-10-30
00811382039393NovoKnee Total Knee SystemNovosource, LLCJWH2026-10-30
00811382039409NovoKnee Total Knee SystemNovosource, LLCJWH2026-10-30
00811382039416NovoKnee Total Knee SystemNovosource, LLCJWH2026-10-30
04260056886089InterSpace® Knee Mold Femoral Component XSOSARTIS GmbHJWH2026-10-29
04260056886102InterSpace® Knee Mold Femoral Component SOSARTIS GmbHJWH2026-10-29
04260056886126InterSpace® Knee Mold Femoral Component MOSARTIS GmbHJWH2026-10-29
04260056886140InterSpace® Knee Mold Femoral Component LOSARTIS GmbHJWH2026-10-29
04260056886164InterSpace® Knee Mold Femoral Component XLOSARTIS GmbHJWH2026-10-29
04260056886188InterSpace® Knee Mold Tibial Component XSOSARTIS GmbHJWH2026-10-29
04260056886201InterSpace® Knee Mold Tibial Component SOSARTIS GmbHJWH2026-10-29
04260056886263InterSpace® Knee Mold Tibial Component XLOSARTIS GmbHJWH2026-10-29
04260056886225InterSpace® Knee Mold Tibial Component MOSARTIS GmbHJWH2026-10-28
04260056886249InterSpace® Knee Mold Tibial Component LOSARTIS GmbHJWH2026-10-28
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