FDA.reportPublic FDA data

Continuum® Trilogy® Allofit® Longevity®

Primary DI
00889024151130
Brand
Continuum® Trilogy® Allofit® Longevity®
Company
Zimmer, Inc.
Model
00-8755-021-36
Catalog number
00-8755-021-36
Published
2015-09-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
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
K103662000
K123019000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K103662000CONTINUUM AND TRILOGY INTEGRATED TAPER (IT) ACETABULAR SYSTEMS; LONGEVITY IT HIGHLY CROSSLINKED POLYETHYLENE ELEVATED LIZimmer, Inc.2011-04-15LPH
K123019000LONGEVITY IT HIGHLY CROSSLINKED POLYETHYENE LINERSZimmer, Inc.2012-10-22LPH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00889024151130PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00889024151130008890241511308890241511300889024151130

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
Device Size Text, specify0
Lumen/Inner Diameter36Millimeter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)348-2759zimmer.consumerrelations@zimmer.com
+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
00889024699854IDENTITY Humeral1200017901200017902026-10-21
00889024699861IDENTITY Humeral1200017911200017912026-10-21
00889024699878IDENTITY Humeral1200017921200017922026-10-21
00889024699885IDENTITY Humeral1200017931200017932026-10-21
00889024699892IDENTITY Humeral1200017941200017942026-10-21
00889024699908IDENTITY Humeral1200017951200017952026-10-21
00889024699915Comprehensive Humeral1200017981200017982026-10-21
00889024699922Identity Humeral1200017991200017992026-10-21
00889024699939N/A1200020041200020042026-10-20
00889024699946N/A1200020051200020052026-10-20
00889024699953Alliance Glenoid, Identity Humeral1200060141200060142026-10-20
00889024709164CANNULATED 1.5MM HEX DRIVERSSI004137SSI0041372026-10-19
00889024709171CANNULATED 2.0MM HEX DRIVERSSI004138SSI0041382026-10-19
00889024715196T6 Driver 127mm AO QCSSI008712SSI0087122026-10-19
00889024715202T8 Driver 127mm AO QCSSI008713SSI0087132026-10-19
00889024715295Persona Extended V/V Guide Assembly (MFS)SSI008760SSI0087602026-10-19
00889024715271Affixus®2113060432113060432026-10-06
00889024707160G7® Vivacit-E®30104005301040052026-09-30
00889024707184G7® Vivacit-E®30103603301036032026-09-30
00889024707207G7® Vivacit-E®30104407301044072026-09-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04719886896602United Hip SystemUNITED ORTHOPEDIC CORP.LZO2026-10-15
04719886896602United Hip SystemUNITED ORTHOPEDIC CORP.LPH2026-10-15
04719886899030United Hip SystemUNITED ORTHOPEDIC CORP.LZO2026-10-15
04719886899030United Hip SystemUNITED ORTHOPEDIC CORP.LPH2026-10-15
04719886899047United Hip SystemUNITED ORTHOPEDIC CORP.LZO2026-10-15
04719886899047United Hip SystemUNITED ORTHOPEDIC CORP.LPH2026-10-15
04719886899054United Hip SystemUNITED ORTHOPEDIC CORP.LZO2026-10-15
04719886899054United Hip SystemUNITED ORTHOPEDIC CORP.LPH2026-10-15
04719886899061United Hip SystemUNITED ORTHOPEDIC CORP.LPH2026-10-15
04719886899061United Hip SystemUNITED ORTHOPEDIC CORP.LZO2026-10-15
04719886899078United Hip SystemUNITED ORTHOPEDIC CORP.LPH2026-10-15
04719886899078United Hip SystemUNITED ORTHOPEDIC CORP.LZO2026-10-15
04719886899085United Hip SystemUNITED ORTHOPEDIC CORP.LPH2026-10-15
04719886899085United Hip SystemUNITED ORTHOPEDIC CORP.LZO2026-10-15
04719886899092United Hip SystemUNITED ORTHOPEDIC CORP.LPH2026-10-15
04719886899092United Hip SystemUNITED ORTHOPEDIC CORP.LZO2026-10-15
04719886899108United Hip SystemUNITED ORTHOPEDIC CORP.LPH2026-10-15
04719886899108United Hip SystemUNITED ORTHOPEDIC CORP.LZO2026-10-15
04719886899115United Hip SystemUNITED ORTHOPEDIC CORP.LPH2026-10-15
04719886899115United Hip SystemUNITED ORTHOPEDIC CORP.LZO2026-10-15
04719886899122United Hip SystemUNITED ORTHOPEDIC CORP.LZO2026-10-15
04719886899122United Hip SystemUNITED ORTHOPEDIC CORP.LPH2026-10-15
04719886899139United Hip SystemUNITED ORTHOPEDIC CORP.LPH2026-10-15
04719886899139United Hip SystemUNITED ORTHOPEDIC CORP.LZO2026-10-15
04719886899146United Hip SystemUNITED ORTHOPEDIC CORP.LZO2026-10-15
04719886899146United Hip SystemUNITED ORTHOPEDIC CORP.LPH2026-10-15
04719886899153United Hip SystemUNITED ORTHOPEDIC CORP.LPH2026-10-15
04719886899153United Hip SystemUNITED ORTHOPEDIC CORP.LZO2026-10-15
04719886899160United Hip SystemUNITED ORTHOPEDIC CORP.LZO2026-10-15
04719886899160United Hip SystemUNITED ORTHOPEDIC CORP.LPH2026-10-15