FDA.reportPublic FDA data

TRIATHLON

Primary DI
07613327639544
Brand
TRIATHLON
Company
Howmedica Osteonics Corp.
Model
5560-S-016-1
Catalog number
5560-S-016-1
Device description
End Cap
Published
2025-08-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
KROPROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KROProsthesis, Knee, Femorotibial, Constrained, Cemented, Metal/PolymerOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K251665000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K251665000Triathlon® Hinge Knee SystemHowmedica Osteonics Corp., Dba Stryker Orthopaedics2025-07-25KRO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07613327639544PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07613327639544076133276395447613327639544

GMDN Terms#

Term, Definition table
TermDefinition
Knee tibia prosthesis plugA small, implantable threaded or non-threaded plug intended to fill the hole in the tibial baseplate of a modular knee tibia prosthesis when the knee tibial stem prosthesis is not used. It is made of metallic and/or synthetic polymer materials, and is screwed or pushed into place.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length20Millimeter

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
058311945
Device count
1
Lot or batch
true

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
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10603295529903ATTUNEDEPUY (IRELAND)KRO2025-10-31
10603295529910ATTUNEDEPUY (IRELAND)KRO2025-10-31
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10603295529965ATTUNEDEPUY (IRELAND)KRO2025-10-31
10603295529972ATTUNEDEPUY (IRELAND)KRO2025-10-31
10603295529989ATTUNEDEPUY (IRELAND)KRO2025-10-31
10603295529996ATTUNEDEPUY (IRELAND)KRO2025-10-31