FDA.reportPublic FDA data

NexGen® Complete Knee Solution

Primary DI
08890240000111
Brand
NexGen® Complete Knee Solution
Company
Zimmer, Inc.
Model
00-5916-030-01
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
08890240000111PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08890240000111088902400001118890240000111

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
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