FDA.reportPublic FDA data

NexGen® Complete Knee Solution

Primary DI
08890240000104
Brand
NexGen® Complete Knee Solution
Company
Zimmer, Inc.
Model
00-5916-030-00
Published
2018-01-05
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
NJLProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NJLProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile BearingUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P060037000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P060037000NEXGEN LPS-FLEX MOBILE AND LPS-MOBILE BEARING KNEE SYSTEMZimmer, Inc.2007-12-10NJL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08890240000104PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08890240000104088902400001048890240000104

GMDN Terms#

Term, Definition table
TermDefinition
Uncoated knee tibia prosthesis, metallicAn implantable device designed to replace the tibial condyles (tibial 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 an insert and/or the femoral prosthetic component of the knee joint and its implantation is intended to be performed with bone cement.

Device Sizes#

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

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
800-348-2759zimmer.consumerrelations@zimmer.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
00889024701281Identity® Shoulder System11007733110077332026-06-10
00889024701298Identity® Shoulder System11007734110077342026-06-10
00889024701304Identity® Shoulder System11007735110077352026-06-10
00889024701311Identity® Shoulder System11007736110077362026-06-10
00889024701328Identity® Shoulder System11007737110077372026-06-10
00889024701335Identity® Shoulder System11007738110077382026-06-10
00889024701342Identity® Shoulder System11007739110077392026-06-10
00889024701359Identity® Shoulder System11007740110077402026-06-10
00889024701366Identity® Shoulder System11007741110077412026-06-10
00889024701373Identity® Shoulder System11007742110077422026-06-10
00889024701380Identity® Shoulder System11007743110077432026-06-10
00889024701397Identity® Shoulder System11007744110077442026-06-10
00889024701403Identity® Shoulder System11007745110077452026-06-10
00889024701410Identity® Shoulder System11007746110077462026-06-10
00889024701427Identity® Shoulder System11007747110077472026-06-10
00889024701434Identity® Shoulder System11007748110077482026-06-10
00889024701441Identity® Shoulder System11007749110077492026-06-10
00889024701458Identity® Shoulder System11007750110077502026-06-10
00889024701465Identity® Shoulder System11007751110077512026-06-10
00889024701472Identity® Shoulder System11007752110077522026-06-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10603295520634ATTUNEDEPUY (IRELAND)NJL2023-06-30
10603295384816TRUMATCHDEPUY (IRELAND)NJL2018-09-24
10603295041863ATTUNEDEPUY (IRELAND)NJL2018-07-03
10603295041870ATTUNEDEPUY (IRELAND)NJL2018-07-03
10603295041887ATTUNEDEPUY (IRELAND)NJL2018-07-03
10603295041894ATTUNEDEPUY (IRELAND)NJL2018-07-03
10603295041917ATTUNEDEPUY (IRELAND)NJL2018-07-03
10603295041931ATTUNEDEPUY (IRELAND)NJL2018-07-03
10603295041948ATTUNEDEPUY (IRELAND)NJL2018-07-03
10603295041962ATTUNEDEPUY (IRELAND)NJL2018-07-03
10603295041979ATTUNEDEPUY (IRELAND)NJL2018-07-03
10603295041986ATTUNEDEPUY (IRELAND)NJL2018-07-03
10603295041993ATTUNEDEPUY (IRELAND)NJL2018-07-03
10603295042006ATTUNEDEPUY (IRELAND)NJL2018-07-03
10603295042013ATTUNEDEPUY (IRELAND)NJL2018-07-03
10603295042044ATTUNEDEPUY (IRELAND)NJL2018-07-03
10603295042051ATTUNEDEPUY (IRELAND)NJL2018-07-03
10603295042082ATTUNEDEPUY (IRELAND)NJL2018-07-03
10603295042105ATTUNEDEPUY (IRELAND)NJL2018-07-03
10603295042112ATTUNEDEPUY (IRELAND)NJL2018-07-03
10603295042129ATTUNEDEPUY (IRELAND)NJL2018-07-03
10603295419563ATTUNEDEPUY (IRELAND)NJL2016-12-05
10603295419570ATTUNEDEPUY (IRELAND)NJL2016-12-05
10603295419587ATTUNEDEPUY (IRELAND)NJL2016-12-05
10603295419594ATTUNEDEPUY (IRELAND)NJL2016-12-05
10603295419600ATTUNEDEPUY (IRELAND)NJL2016-12-05
10603295419617ATTUNEDEPUY (IRELAND)NJL2016-12-05
10603295436461ATTUNEDEPUY (IRELAND)NJL2016-12-05
10603295436492ATTUNEDEPUY (IRELAND)NJL2016-12-05
10603295436508ATTUNEDEPUY (IRELAND)NJL2016-12-05