FDA.reportPublic FDA data

Omnifit

Primary DI
07613327021578
Brand
Omnifit
Company
Howmedica Osteonics Corp.
Model
2006-3261
Catalog number
2006-3261
Device description
20 Degree Series I Insert
Published
2015-09-24
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

Product Codes#

Code, Name table
CodeName
JDLProsthesis, hip, semi-constrained (metal cemented acetabular component)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JDLProsthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component)Orthopedic3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K243784000
K261624000
K850352000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K243784000Stryker Orthopaedics Hip Devices Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics2025-02-06LPH
K261624000Omnifit® 20° Series I Insert;Omnifit® Crossfire® 10° Series II Insert; Constrained Acetabular Insert; Trident® Crossfire® 0° Polyethylene Insert; Trident ® Crossfire ® 10° Polyethylene Insert;System 12 Crossfire® 10° Insert; Trident® 0° Constrained Acetabular Insert; Trident® Constrained Acetabular Liner;Trident® All Poly Constrained Acetabular Insert; Crossfire® Eccentric Insert 10°; Artisan® Bone Plug;UHR® Universal Head Bipolar ComponentHowmedica Osteonics Corp., Dba Stryker Orthopaedics2026-07-10LPH
K850352000MICRO-STRUC. ACETABULAR COMPON- MC2POsteonics Corp.1985-04-25JDL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07613327021578PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07613327021578076133270215787613327021578

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 Diameter0

Regulatory Flags#

DUNS number
058311945
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
false
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
04546540035523Omnifit2041C-22402041C-22402015-09-24
04546540035714Omnifit2041C-28462041C-28462015-09-24
04546540035790Omnifit2041C-32502041C-32502015-09-24
04546540035806Omnifit2041C-32542041C-32542015-09-24
04546540035813Omnifit2041C-32582041C-32582015-09-24
04546540035820Omnifit2041C-32622041C-32622015-09-24
04546540035837Omnifit2041C-32662041C-32662015-09-24
07613327016772UHRUH1-36-22UH1-36-222015-09-24
07613327016789UHRUH1-38-22UH1-38-222015-09-24
07613327016796UHRUH1-40-22UH1-40-222015-09-24
07613327016802UHRUH1-41-26UH1-41-262015-09-24
07613327016819UHRUH1-41-22UH1-41-222015-09-24
07613327016826UHRUH1-42-26UH1-42-262015-09-24
07613327016833UHRUH1-42-22UH1-42-222015-09-24
07613327016840UHRUH1-43-22UH1-43-222015-09-24
07613327016857UHRUH1-42-28UH1-42-282015-09-24
07613327016864UHRUH1-43-26UH1-43-262015-09-24
07613327016871UHRUH1-44-22UH1-44-222015-09-24
07613327016888UHRUH1-44-26UH1-44-262015-09-24
07613327016895UHRUH1-44-28UH1-44-282015-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840286800570Consensus Hip SystemShalby Advanced Technologies, Inc.JDL2022-01-06
00840286800587Consensus Hip SystemShalby Advanced Technologies, Inc.JDL2022-01-06
00840286800594Consensus Hip SystemShalby Advanced Technologies, Inc.JDL2022-01-06
00840286800600Consensus Hip SystemShalby Advanced Technologies, Inc.JDL2022-01-06
00840286800617Consensus Hip SystemShalby Advanced Technologies, Inc.JDL2022-01-06
00840286800624Consensus Hip SystemShalby Advanced Technologies, Inc.JDL2022-01-06
00840286800631Consensus Hip SystemShalby Advanced Technologies, Inc.JDL2022-01-06
00840286800648Consensus Hip SystemShalby Advanced Technologies, Inc.JDL2022-01-06
00880304498167Taperloc Complete Primary FemoralBiomet Orthopedics, LLCJDL2018-12-19
00880304498174Taperloc Complete Primary FemoralBiomet Orthopedics, LLCJDL2018-12-19
00880304499065Taperloc Complete Primary FemoralBiomet Orthopedics, LLCJDL2018-12-19
00880304499072Taperloc Complete Primary FemoralBiomet Orthopedics, LLCJDL2018-12-19
00880304452732TAPERLOCBiomet Orthopedics, LLCJDL2017-07-28
00880304452749TAPERLOCBiomet Orthopedics, LLCJDL2017-07-28
00880304452756TAPERLOCBiomet Orthopedics, LLCJDL2017-07-28
B27826000025E0ELEOS™ONKOS SURGICAL, INC.JDL2017-04-03
B27826000026E0ELEOS™ONKOS SURGICAL, INC.JDL2017-04-03
00880304461604Compress DeviceBiomet Orthopedics, LLCJDL2015-10-24
00880304461611Compress® DeviceBiomet Orthopedics, LLCJDL2015-10-24
00880304461628Compress® DeviceBiomet Orthopedics, LLCJDL2015-10-24
00880304461635Compress® DeviceBiomet Orthopedics, LLCJDL2015-10-24
00880304461642Compress® DeviceBiomet Orthopedics, LLCJDL2015-10-24
00880304461659Compress® DeviceBiomet Orthopedics, LLCJDL2015-10-24
00880304461666Compress® DeviceBiomet Orthopedics, LLCJDL2015-10-24
00880304461673Compress® DeviceBiomet Orthopedics, LLCJDL2015-10-24
00880304461680Compress® DeviceBiomet Orthopedics, LLCJDL2015-10-24
00880304461697Compress® DeviceBiomet Orthopedics, LLCJDL2015-10-24
00880304461703Compress® DeviceBiomet Orthopedics, LLCJDL2015-10-24
00880304461765Compress DeviceBiomet Orthopedics, LLCJDL2015-10-24
00880304461772Compress DeviceBiomet Orthopedics, LLCJDL2015-10-24