FDA.reportPublic FDA data

TRABECULAR METAL™

Primary DI
00889024308992
Brand
TRABECULAR METAL™
Company
ZIMMER TRABECULAR METAL TECHNOLOGY INC.
Model
00-5452-013-20
Published
2016-05-24
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
FZXGuide, surgical, instrument
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
FZXGuide, Surgical, InstrumentGeneral, Plastic Surgery1
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
K102896000
K103517000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K102896000TRABECULAR METAL TIBIAL CONE AUGMENTSZimmer Trabecular Metal Technology2010-12-13MBH
K103517000TRABECULAR METAL FEMORAL CONE AUGMENTSZimmer Trabecular Metal Technology, Inc.2011-02-15MBH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00889024308992PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00889024308992008890243089928890243089920889024308992

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic prosthesis implantation instrument, reusableA hand-held surgical instrument intended to be used during implantation of an orthopaedic prosthesis, either manually or as a computer-assisted surgery (CAS) device, to aid in the navigation/placement of the prosthesis or other instruments. It may be used for the following applications: 1) to hold/align/fix bone preparation instruments, prosthesis, or prosthesis component; 2) to provide relative position landmarks; 3) to ascertain correct spatial orientation or limb alignment; and/or 4) as an interface between prosthesis components. This is a reusable device intended to be sterilized prior to use.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

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

Regulatory Flags#

DUNS number
793120965
Device count
1
Lot or batch
true
Sterilization required before use
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
00190776411091MillenniumAvalign Technologies, Inc.FZX2026-08-07
06438408012815Inion CompressOn™ / Inion FreedomScrew™ InstrumentInion OyFZX2026-08-07
06438408012822Inion CompressOn™ / Inion FreedomScrew™ InstrumentInion OyFZX2026-08-07
06438408012839Inion CompressOn™ InstrumentInion OyFZX2026-08-07
00840097536552iTotal Identity CR 3DP PorousRestor3d, Inc.MBH2026-07-31
00840097536552iTotal Identity CR 3DP PorousRestor3d, Inc.JWH2026-07-31
00840097536569iTotal Identity CR 3DP PorousRestor3d, Inc.MBH2026-07-31
00840097536569iTotal Identity CR 3DP PorousRestor3d, Inc.JWH2026-07-31
00840097536576iTotal Identity CR 3DP PorousRestor3d, Inc.MBH2026-07-31
00840097536576iTotal Identity CR 3DP PorousRestor3d, Inc.JWH2026-07-31
00840097536583iTotal Identity CR 3DP PorousRestor3d, Inc.JWH2026-07-31
00840097536583iTotal Identity CR 3DP PorousRestor3d, Inc.MBH2026-07-31
00840097536590iTotal Identity CR 3DP PorousRestor3d, Inc.JWH2026-07-31
00840097536590iTotal Identity CR 3DP PorousRestor3d, Inc.MBH2026-07-31
00840606191838Overwatch PCFSPINAL ELEMENTS, INC.FZX2026-07-31
00840606191845Overwatch PCFSPINAL ELEMENTS, INC.FZX2026-07-31
03701089509695AMPLITUDEAMPLITUDE SASJWH2026-07-31
00190376544496InvictusALPHATEC SPINE, INC.FZX2026-07-30
03701089517492TRAXAMPLITUDE SASJWH2026-07-29
03701089517508TRAXAMPLITUDE SASJWH2026-07-29
03701089517515TRAXAMPLITUDE SASJWH2026-07-29
03701089517522TRAXAMPLITUDE SASJWH2026-07-29
03701089517539TRAXAMPLITUDE SASJWH2026-07-29
03701089517546TRAXAMPLITUDE SASJWH2026-07-29
03701089517553TRAXAMPLITUDE SASJWH2026-07-29
03701089517560TRAXAMPLITUDE SASJWH2026-07-29
03701089517577TRAXAMPLITUDE SASJWH2026-07-29
03701089517584TRAXAMPLITUDE SASJWH2026-07-29
03701089517591TRAXAMPLITUDE SASJWH2026-07-29
03701089517607TRAXAMPLITUDE SASJWH2026-07-29