FDA.reportPublic FDA data

N/A

Primary DI
00889024196001
Brand
N/A
Company
Zimmer, Inc.
Model
00-5850-046-04
Catalog number
00-5850-046-04
Published
2015-09-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KROPROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KROProsthesis, Knee, Femorotibial, Constrained, Cemented, Metal/PolymerOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00889024196001PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00889024196001008890241960018890241960010889024196001

GMDN Terms#

Term, Definition table
TermDefinition
Knee stemA sterile device designed to provide additional stability for an implanted knee femur prosthesis by extending the attachment of the prosthesis from the distal femur into the midshaft of the bone. It is typically a shaft-like device made of metal [e.g., cobalt-chrome (Co-Cr)] and is often used in prosthesis revision to compensate for bone loss.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length40Millimeter

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
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00887868150876Affixus®8151113008151113002026-03-20
00887868150333Affixus®8151103008151103002026-03-19
00887868150340Affixus®8151103208151103202026-03-19
00887868150357Affixus®8151103408151103402026-03-19
00887868150364Affixus®8151103608151103602026-03-19
00887868150371Affixus®8151103808151103802026-03-19
00887868150388Affixus®8151104008151104002026-03-19
00887868150395Affixus®8151104208151104202026-03-19
00887868150401Affixus®8151114208151114202026-03-19
00887868150555Affixus®8151123008151123002026-03-19
00887868150562Affixus®8151123208151123202026-03-19
00887868150579Affixus®8151123408151123402026-03-19
00887868150586Affixus®8151123608151123602026-03-19
00887868150593Affixus®8151123808151123802026-03-19
00887868150609Affixus®8151124008151124002026-03-19
00887868150616Affixus®8151124208151124202026-03-19
00887868150883Affixus®8151113208151113202026-03-19
00887868150890Affixus®8151113408151113402026-03-19
00887868150906Affixus®8151113608151113602026-03-19
00887868150913Affixus®8151113808151113802026-03-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00889024703278OSS™ Orthopedic Salvage SystemBiomet Orthopedics, LLCKRO2025-12-09
00889024703308OSS™ Orthopedic Salvage SystemBiomet Orthopedics, LLCKRO2025-12-09
00889024702011OSS™ Orthopedic Salvage SystemBiomet Orthopedics, LLCKRO2025-12-05
00889024702028OSS™ Orthopedic Salvage SystemBiomet Orthopedics, LLCKRO2025-12-05
00889024703285OSS™ Orthopedic Salvage SystemBiomet Orthopedics, LLCKRO2025-12-02
00889024703322OSS™ Orthopedic Salvage SystemBiomet Orthopedics, LLCKRO2025-12-02
04719872142812USTAR II Knee SystemUNITED ORTHOPEDIC CORP.KRO2025-09-11
04719872142829USTAR II Knee SystemUNITED ORTHOPEDIC CORP.KRO2025-09-11
04719886893175USTAR II Knee SystemUNITED ORTHOPEDIC CORP.KRO2025-09-11
04719886893182USTAR II Knee SystemUNITED ORTHOPEDIC CORP.KRO2025-09-11
04719886903560USTAR II Knee SystemUNITED ORTHOPEDIC CORP.KRO2025-09-11
04719886903577USTAR II Knee SystemUNITED ORTHOPEDIC CORP.KRO2025-09-11
04719886903584USTAR II Knee SystemUNITED ORTHOPEDIC CORP.KRO2025-09-11
04719886903591USTAR II Knee SystemUNITED ORTHOPEDIC CORP.KRO2025-09-11
04719886903607USTAR II Knee SystemUNITED ORTHOPEDIC CORP.KRO2025-09-11
04719886903614USTAR II Knee SystemUNITED ORTHOPEDIC CORP.KRO2025-09-11
04719886903621USTAR II Knee SystemUNITED ORTHOPEDIC CORP.KRO2025-09-11
04719886903638USTAR II Knee SystemUNITED ORTHOPEDIC CORP.KRO2025-09-11
04719886908411USTAR II Knee SystemUNITED ORTHOPEDIC CORP.KRO2025-09-08
04719886908428USTAR II Knee SystemUNITED ORTHOPEDIC CORP.KRO2025-09-08
04719886908435USTAR II Knee SystemUNITED ORTHOPEDIC CORP.KRO2025-09-08
04719886908442USTAR II Knee SystemUNITED ORTHOPEDIC CORP.KRO2025-09-08
04719886908459USTAR II Knee SystemUNITED ORTHOPEDIC CORP.KRO2025-09-08
04719886908466USTAR II Knee SystemUNITED ORTHOPEDIC CORP.KRO2025-09-08
04719886908473USTAR II Knee SystemUNITED ORTHOPEDIC CORP.KRO2025-09-08
04719886908480USTAR II Knee SystemUNITED ORTHOPEDIC CORP.KRO2025-09-08
04719886908497USTAR II Knee SystemUNITED ORTHOPEDIC CORP.KRO2025-09-08
04719886908503USTAR II Knee SystemUNITED ORTHOPEDIC CORP.KRO2025-09-08
04719886908510USTAR II Knee SystemUNITED ORTHOPEDIC CORP.KRO2025-09-08
04719886908527USTAR II Knee SystemUNITED ORTHOPEDIC CORP.KRO2025-09-08