FDA.reportPublic FDA data

NexGen® Complete Knee Solution

Primary DI
08890240000180
Brand
NexGen® Complete Knee Solution
Company
Zimmer, Inc.
Model
00-5916-040-00
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
08890240000180PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08890240000180088902400001808890240000180

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
00889024711464Comp Mini Humeral Tray Trial Stem AdapterSSI008664SSI0086642026-08-25
008890247114712.9 JuggerKnot Self-Punching ObturatorSSI008672SSI0086722026-08-25
008890247114882.9 JuggerKnot Self-Punching CannulaSSI008671SSI0086712026-08-25
00889024712294Pin Target AssemblySSI001470SSI0014702026-08-25
00889024712300Z1 POSTERIOR HAMMR ADPTRSSI008666SSI0086662026-08-25
00889024712317Z1 ANTERIOR HAMMR ADPTRSSI008665SSI0086652026-08-25
00889024712843PTH SHELL PSTNR ASSYSSI008611SSI0086112026-08-25
00889024712850PTH SHELL ADPTR SMLLSSI008612SSI0086122026-08-25
00889024712867PTH SHELL ADPTR LRGSSI008658SSI0086582026-08-25
00889024712874PTH BOOMSSI008680SSI0086802026-08-25
00889024712881PTH TROCARSSI008681SSI0086812026-08-25
008890247128986.5/8.0mm Countersink, Cannulated ZH QCSSI008697SSI0086972026-08-25
00889024712904RMR LONG KEYSSI008690SSI0086902026-08-25
00889024712911X BAR RMR ADPT TALLSSI008688SSI0086882026-08-25
00889024712928RMR SHORT KEYSSI008689SSI0086892026-08-25
00889024712935RMR SHORT KEY BENTSSI008691SSI0086912026-08-25
00889024712942RMR LONG KEY BENTSSI008692SSI0086922026-08-25
00889024713277Universal Uni Knee TensorSSI008695SSI0086952026-08-25
00889024713284Right Uni Knee TensorSSI008696SSI0086962026-08-25
00889024713291Left Uni Knee TensorSSI008694SSI0086942026-08-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
10603295436515ATTUNEDEPUY (IRELAND)NJL2016-12-05