FDA.reportPublic FDA data

NexGen® Complete Knee Solution

Primary DI
00889024665200
Brand
NexGen® Complete Knee Solution
Company
Zimmer, Inc.
Model
00-5917-040-12
Catalog number
00-5917-040-12
Published
2024-11-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
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
P060037009
P060037027
P060037040
P060037059
P060037060

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P060037000NEXGEN LPS-FLEX MOBILE AND LPS-MOBILE BEARING KNEE SYSTEMZimmer, Inc.2007-12-10NJL
P060037009NEXGEN LPS-FLEX MOBILE AND LPS-MOBILE BEARING KNEE SYSTEMZimmer, Inc.2007-12-10NJL
P060037027NEXGEN LPS-FLEX MOBILE AND LPS-MOBILE BEARING KNEE SYSTEMZimmer, Inc.2007-12-10NJL
P060037040NEXGEN LPS-FLEX MOBILE AND LPS-MOBILE BEARING KNEE SYSTEMZimmer, Inc.2007-12-10NJL
P060037059NEXGEN LPS-FLEX MOBILE AND LPS-MOBILE BEARING KNEE SYSTEMZimmer, Inc.2007-12-10NJL
P060037060NEXGEN LPS-FLEX MOBILE AND LPS-MOBILE BEARING KNEE SYSTEMZimmer, Inc.2007-12-10NJL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00889024665200PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00889024665200008890246652008890246652000889024665200

GMDN Terms#

Term, Definition table
TermDefinition
Tibial insertAn implantable device designed to articulate the femoral and tibial components of a knee joint prosthesis during primary or revision bicondylar knee joint replacement. It is typically a one-piece contoured polyethylene (PE) insert, or a more complex device (e.g., a guide arm with a stem that is inserted into the tibial tray and a polymer glide) which will better reproduce the flexion of the knee joint due to its capacity for lateral rotation and anterior/posterior movement. This device is typically made of metal and/or a polymer.

Device Sizes#

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

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
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

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