FDA.report

NexGen®

Primary DI
00889024633971
Brand
NexGen®
Company
Zimmer, Inc.
Model
00-5850-075-15
Catalog number
00-5850-075-15
Published
2022-02-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
KROPROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

Product Code Classifications

CodeDeviceSpecialtyClass
KROProsthesis, Knee, Femorotibial, Constrained, Cemented, Metal/PolymerOrthopedic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00889024633971PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00889024633971008890246339718890246339710889024633971

GMDN Terms

TermDefinition
Uncoated knee femur prosthesis, metallicAn implantable device designed to replace the femoral condyles (femoral component) during primary bicondylar replacement of the knee joint, femoral bone resection, or to replace a dysfunctional knee prosthesis (revision); it is made of metal [e.g., cobalt-chrome (Co-Cr), cobalt-chrome-molybdenum (Co-Cr-Mo), titanium (Ti)] and is not coated with a material intended to improve fixation and stability by promoting bone ingrowth. The device is designed to articulate with tibial and, if required, patellar prosthetic components of the knee joint and its implantation is intended to be performed with bone cement.

Device Sizes

TypeValueUnit
Device Size Text, specify0

Sterilization Methods

Method

Contacts

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

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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 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