FDA.reportPublic FDA data

NA

Primary DI
00889024644243
Brand
NA
Company
Zimmer, Inc.
Model
4366-32-071
Catalog number
4366-32-071
Published
2022-02-25
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
JDIProsthesis, hip, semi-constrained, metal/polymer, cemented
LPHPROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
LZOProsthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JDIProsthesis, Hip, Semi-Constrained, Metal/Polymer, CementedOrthopedic2
LPHProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous UncementedOrthopedic2
LZOProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, UncementedOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K955033000
K955739000
K970705000
K970706000
K972393000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K955033000RIM FLARE ACETABULAR COMPONENTIntermedics Orthopedics1996-01-31LPH
K955739000MODULAR ACETABULAR SHELL IIIntermedics Orthopedics1996-03-27LPH
K970705000INTER-OP POROUS REVISION SHELL WITH SEALABLE SCREWHOLESSulzer Orthopedics, Inc.1997-05-22LPH
K970706000INTER-OP POROUS PROTRUSIO SHELL WITH SEALABLE SCREWHOLESSulzer Orthopedics, Inc.1997-05-22LPH
K972393000INTER-OP HA POROUS ACETABULAR SYSTEM (HA/CSTI)Sulzer Orthopedics, Inc.1997-09-19LPH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00889024644243PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00889024644243008890246442438890246442430889024644243

GMDN Terms#

Term, Definition table
TermDefinition
Non-constrained polyethylene acetabular linerA sterile, implantable component of a two-piece acetabulum prosthesis that is inserted into an acetabular shell prosthesis to provide the articulating surface with a femoral head prosthesis as part of a total hip arthroplasty (THA). It is made of polyethylene (includes hylamer, cross-linked polyethylene), and does not include a stabilizing component to limit the range of motion of the hip.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Lumen/Inner Diameter32Millimeter
Outer Diameter71Millimeter

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
05056139247293Icona Hip StemCORIN LTDLZO2025-04-07
10885862015181AuraExactech, Inc.JDI2022-10-04
10885862015198AuraExactech, Inc.JDI2022-10-04
10885862015204AuraExactech, Inc.JDI2022-10-04
10885862015211AuraExactech, Inc.JDI2022-10-04
10885862013743NAExactech, Inc.JDI2022-09-20
10885862013743NAExactech, Inc.LPH2022-09-20
10885862013750NAExactech, Inc.JDI2022-09-20
10885862013750NAExactech, Inc.LPH2022-09-20
10885862010551NAExactech, Inc.JDI2022-08-18
10885862010551NAExactech, Inc.LPH2022-08-18
10885862010575NAExactech, Inc.LPH2022-08-18
10885862010575NAExactech, Inc.JDI2022-08-18
10885862010582NAExactech, Inc.JDI2022-08-18
10885862010582NAExactech, Inc.LPH2022-08-18
10885862010872NAExactech, Inc.JDI2022-08-18
10885862010872NAExactech, Inc.LPH2022-08-18
10885862010872NAExactech, Inc.LZO2022-08-18
10885862010889NAExactech, Inc.LPH2022-08-18
10885862010889NAExactech, Inc.JDI2022-08-18
10885862010889NAExactech, Inc.LZO2022-08-18
10885862010896NAExactech, Inc.LPH2022-08-18
10885862010896NAExactech, Inc.JDI2022-08-18
10885862010896NAExactech, Inc.LZO2022-08-18
10885862015112AuraExactech, Inc.JDI2022-08-18
10885862015129AuraExactech, Inc.JDI2022-08-18
10885862015136AuraExactech, Inc.JDI2022-08-18
10885862015143AuraExactech, Inc.JDI2022-08-18
10885862015150AuraExactech, Inc.JDI2022-08-18
10885862015167AuraExactech, Inc.JDI2022-08-18