FDA.reportPublic FDA data

TRABECULAR METAL®

Primary DI
00889024308459
Brand
TRABECULAR METAL®
Company
Zimmer, Inc.
Model
00-5450-020-36
Catalog number
00-5450-020-36
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
K103517000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K103517000TRABECULAR METAL FEMORAL CONE AUGMENTSZimmer Trabecular Metal Technology, Inc.2011-02-15MBH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00889024308459PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00889024308459008890243084598890243084590889024308459

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Height35Millimeter

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
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
00889024702356OsseoFit00-5381-017-1100-5381-017-112026-10-28
00889024702363OsseoFit00-5381-017-1200-5381-017-122026-10-28
00889024702370OsseoFit00-5381-017-1300-5381-017-132026-10-28
00889024702387OsseoFit00-5381-017-1400-5381-017-142026-10-28
00889024702394OsseoFit00-5381-017-1500-5381-017-152026-10-28
00889024702400OsseoFit00-5381-017-1600-5381-017-162026-10-28
00889024702417OsseoFit00-5381-017-2100-5381-017-212026-10-28
00889024702424OsseoFit00-5381-017-2200-5381-017-222026-10-28
00889024702431OsseoFit00-5381-017-2300-5381-017-232026-10-28
00889024702448OsseoFit00-5381-017-2400-5381-017-242026-10-28
00889024702455OsseoFit00-5381-017-2500-5381-017-252026-10-28
00889024702462OsseoFit00-5381-017-2600-5381-017-262026-10-28
00889024702233OsseoFit00-5381-008-0500-5381-008-052026-10-27
00889024702240OsseoFit00-5381-008-0600-5381-008-062026-10-27
00889024702257OsseoFit00-5381-013-0000-5381-013-002026-10-27
00889024702264OsseoFit00-5381-013-1000-5381-013-102026-10-27
00889024702271OsseoFit00-5381-013-1100-5381-013-112026-10-27
00889024702295OsseoFit00-5381-013-1300-5381-013-132026-10-27
00889024702301OsseoFit00-5381-014-0000-5381-014-002026-10-27
00889024702318OsseoFit00-5381-014-0100-5381-014-012026-10-27

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