FDA.reportPublic FDA data

NexGen® Complete Knee Solution

Primary DI
00889024665231
Brand
NexGen® Complete Knee Solution
Company
Zimmer, Inc.
Model
00-5917-040-20
Catalog number
00-5917-040-20
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
P060037055
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
P060037055NEXGEN 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
00889024665231PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00889024665231008890246652318890246652310889024665231

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
00889024081024XtraFix® Large External Fixation System00-5207-024-3000-5207-024-302016-08-09
00889024081055XtraFix® Large External Fixation System00-5207-032-3000-5207-032-302016-07-27
00889024081062XtraFix® Large External Fixation System00-5207-040-1000-5207-040-102016-07-28
00889024081079XtraFix® Large External Fixation System00-5207-040-7000-5207-040-702016-07-28
00889024081086XtraFix® Large External Fixation System00-5207-045-1000-5207-045-102016-07-28
00889024081093XtraFix® Large External Fixation System00-5210-009-0100-5210-009-012016-09-28
00889024081109XtraFix® Large External Fixation System00-5210-009-0200-5210-009-022016-09-28
00889024081147XtraFix® Large External Fixation System00-5210-019-0100-5210-019-012016-09-28
00889024081154XtraFix® Large External Fixation System00-5210-029-0100-5210-029-012016-09-28
00889024081178XtraFix® Large External Fixation System00-5210-040-0000-5210-040-002016-09-28
00889024081185XtraFix® Large External Fixation System00-5210-040-0100-5210-040-012016-09-28
00889024081192XtraFix® Large External Fixation System00-5210-040-0200-5210-040-022016-09-28
00889024081208XtraFix® Large External Fixation System00-5210-040-0300-5210-040-032016-09-28
00889024081215XtraFix® Large External Fixation System00-5210-040-0400-5210-040-042016-09-28
00889024081239XtraFix® Large External Fixation System00-5210-040-0600-5210-040-062016-09-28
00889024081253XtraFix® Large External Fixation System00-5210-050-0100-5210-050-012016-09-28
00889024081260XtraFix® Large External Fixation System00-5210-050-0200-5210-050-022016-09-28
00889024081277XtraFix® Large External Fixation System00-5210-050-0300-5210-050-032016-09-28
00889024081284XtraFix® Large External Fixation System00-5210-050-0400-5210-050-042016-09-28
00889024081307XtraFix® Large External Fixation System00-5210-050-0600-5210-050-062016-09-28

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