FDA.reportPublic FDA data

NexGen® Prolong®

Primary DI
00889024429154
Brand
NexGen® Prolong®
Company
Zimmer, Inc.
Model
5952-20-12
Catalog number
00-5952-020-12
Published
2019-10-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JWHPROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/PolymerOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K003910000
K013991000
K173057000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K003910000NEXGEN COMPLETE KNEE SOLUTION CROSS-LINKED POLYETHYLENE CRUCIATE RETAINING (CR) ARTICULAR SURFACE COMPONENTSZimmer, Inc.2001-03-19JWH
K013991000PROLONG HIGHLY CROSSLINKED POLYETHTYLENE CRUCIATE RETAINING (CR) ARTICULAR SURFACE COMPONENTSZimmer, Inc.2001-12-27JWH
K173057000Zimmer Knee Joint Replacement Prostheses MR LabelingZimmer, Inc.2018-03-29JWH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00889024429154PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00889024429154008890244291548890244291540889024429154

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
Height12Millimeter

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
Expiration date on label
true

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
00192629005419ADVANCE®Microport Orthopedics Inc.JWH2026-09-18
00192629005426ADVANCE®Microport Orthopedics Inc.JWH2026-09-18
00192629005433ADVANCE®Microport Orthopedics Inc.JWH2026-09-18
00192629005440ADVANCE®Microport Orthopedics Inc.JWH2026-09-18
00192629005457ADVANCE®Microport Orthopedics Inc.JWH2026-09-18
00192629005464ADVANCE®Microport Orthopedics Inc.JWH2026-09-18
00192629005488ADVANCE®Microport Orthopedics Inc.JWH2026-09-18
00192629005495ADVANCE®Microport Orthopedics Inc.JWH2026-09-18
00192629005501ADVANCEMicroport Orthopedics Inc.JWH2026-09-18
00192629005518ADVANCEMicroport Orthopedics Inc.JWH2026-09-18
00192629005549ADVANCE®Microport Orthopedics Inc.JWH2026-09-18
00192629005556ADVANCE®Microport Orthopedics Inc.JWH2026-09-18
00192629005563ADVANCE®Microport Orthopedics Inc.JWH2026-09-18
00192629005570ADVANCE®Microport Orthopedics Inc.JWH2026-09-18
00192629082854EVOLUTIONMicroport Orthopedics Inc.JWH2026-09-18
00192629082861EVOLUTIONMicroport Orthopedics Inc.JWH2026-09-18
00192629082878EVOLUTIONMicroport Orthopedics Inc.JWH2026-09-18
00192629082885EVOLUTIONMicroport Orthopedics Inc.JWH2026-09-18
00192629082892EVOLUTIONMicroport Orthopedics Inc.JWH2026-09-18
00192629082908EVOLUTIONMicroport Orthopedics Inc.JWH2026-09-18
00192629082915EVOLUTIONMicroport Orthopedics Inc.JWH2026-09-18
00192629082922EVOLUTIONMicroport Orthopedics Inc.JWH2026-09-18
00192629082939EVOLUTIONMicroport Orthopedics Inc.JWH2026-09-18
00192629082946EVOLUTIONMicroport Orthopedics Inc.JWH2026-09-18
00192629082953EVOLUTIONMicroport Orthopedics Inc.JWH2026-09-18
00192629082960EVOLUTIONMicroport Orthopedics Inc.JWH2026-09-18
00192629082977EVOLUTIONMicroport Orthopedics Inc.JWH2026-09-18
00192629082984EVOLUTIONMicroport Orthopedics Inc.JWH2026-09-18
00192629082991EVOLUTIONMicroport Orthopedics Inc.JWH2026-09-18
00192629083004EVOLUTIONMicroport Orthopedics Inc.JWH2026-09-18