FDA.reportPublic FDA data

TRIATHLON

Primary DI
07613327601992
Brand
TRIATHLON
Company
Howmedica Osteonics Corp.
Model
5612-P-422
Catalog number
5612-P-422
Device description
Hinge Insert
Published
2023-07-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07613327601992PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07613327601992076133276019927613327601992

GMDN Terms#

Term, Definition table
TermDefinition
Rotating hinged total knee prosthesisA sterile implantable artificial substitute for a knee joint typically designed to replace all the articulating surfaces of the joint [total knee arthroplasty (TKA)] because of major loss of stabilizing structures or bone around the knee, often from tumour resection, or to replace a dysfunctional knee prosthesis (revision); it is designed with a mechanism for joint rotation and its major components are connected for stability typically about a transverse axis posterior of the rotational axis. It typically includes femoral, tibial, and patellar components that articulate and with parts made of metal, ceramic, and/or polyethylene (PE); it may be implated with or without bone cement.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
058311945
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
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
07613327660180Instrument5533-T-409-R5533-T-409-R2026-02-27
07613327648386Instrument5533-T-812-R5533-T-812-R2026-02-26
07613327648393Instrument5533-T-811-L5533-T-811-L2026-02-26
07613327648409Instrument5533-T-812-L5533-T-812-L2026-02-26
07613327648416Instrument5533-T-810-R5533-T-810-R2026-02-26
07613327648423Instrument5533-T-816-L5533-T-816-L2026-02-26
07613327648430Instrument5533-T-809-L5533-T-809-L2026-02-26
07613327648447Instrument5533-T-814-R5533-T-814-R2026-02-26
07613327648454Instrument5533-T-809-R5533-T-809-R2026-02-26
07613327648461Instrument5533-T-810-L5533-T-810-L2026-02-26
07613327648478Instrument5533-T-811-R5533-T-811-R2026-02-26
07613327648485Instrument5533-T-816-R5533-T-816-R2026-02-26
07613327648492Instrument5533-T-814-L5533-T-814-L2026-02-26
07613327651485Instrument5533-T-010-R5533-T-010-R2026-02-26
07613327651492Instrument5533-T-012-R5533-T-012-R2026-02-26
07613327651508Instrument5533-T-016-R5533-T-016-R2026-02-26
07613327651515Instrument5533-T-011-L5533-T-011-L2026-02-26
07613327651522Instrument5533-T-014-L5533-T-014-L2026-02-26
07613327651539Instrument5533-T-009-L5533-T-009-L2026-02-26
07613327651546Instrument5533-T-016-L5533-T-016-L2026-02-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00889024703278OSS™ Orthopedic Salvage SystemBiomet Orthopedics, LLCKRO2025-12-09
00889024703308OSS™ Orthopedic Salvage SystemBiomet Orthopedics, LLCKRO2025-12-09
00889024702011OSS™ Orthopedic Salvage SystemBiomet Orthopedics, LLCKRO2025-12-05
00889024702028OSS™ Orthopedic Salvage SystemBiomet Orthopedics, LLCKRO2025-12-05
00889024703285OSS™ Orthopedic Salvage SystemBiomet Orthopedics, LLCKRO2025-12-02
00889024703322OSS™ Orthopedic Salvage SystemBiomet Orthopedics, LLCKRO2025-12-02
04719872142812USTAR II Knee SystemUNITED ORTHOPEDIC CORP.KRO2025-09-11
04719872142829USTAR II Knee SystemUNITED ORTHOPEDIC CORP.KRO2025-09-11
04719886893175USTAR II Knee SystemUNITED ORTHOPEDIC CORP.KRO2025-09-11
04719886893182USTAR II Knee SystemUNITED ORTHOPEDIC CORP.KRO2025-09-11
04719886903560USTAR II Knee SystemUNITED ORTHOPEDIC CORP.KRO2025-09-11
04719886903577USTAR II Knee SystemUNITED ORTHOPEDIC CORP.KRO2025-09-11
04719886903584USTAR II Knee SystemUNITED ORTHOPEDIC CORP.KRO2025-09-11
04719886903591USTAR II Knee SystemUNITED ORTHOPEDIC CORP.KRO2025-09-11
04719886903607USTAR II Knee SystemUNITED ORTHOPEDIC CORP.KRO2025-09-11
04719886903614USTAR II Knee SystemUNITED ORTHOPEDIC CORP.KRO2025-09-11
04719886903621USTAR II Knee SystemUNITED ORTHOPEDIC CORP.KRO2025-09-11
04719886903638USTAR II Knee SystemUNITED ORTHOPEDIC CORP.KRO2025-09-11
04719886908411USTAR II Knee SystemUNITED ORTHOPEDIC CORP.KRO2025-09-08
04719886908428USTAR II Knee SystemUNITED ORTHOPEDIC CORP.KRO2025-09-08
04719886908435USTAR II Knee SystemUNITED ORTHOPEDIC CORP.KRO2025-09-08
04719886908442USTAR II Knee SystemUNITED ORTHOPEDIC CORP.KRO2025-09-08
04719886908459USTAR II Knee SystemUNITED ORTHOPEDIC CORP.KRO2025-09-08
04719886908466USTAR II Knee SystemUNITED ORTHOPEDIC CORP.KRO2025-09-08
04719886908473USTAR II Knee SystemUNITED ORTHOPEDIC CORP.KRO2025-09-08
04719886908480USTAR II Knee SystemUNITED ORTHOPEDIC CORP.KRO2025-09-08
04719886908497USTAR II Knee SystemUNITED ORTHOPEDIC CORP.KRO2025-09-08
04719886908503USTAR II Knee SystemUNITED ORTHOPEDIC CORP.KRO2025-09-08
04719886908510USTAR II Knee SystemUNITED ORTHOPEDIC CORP.KRO2025-09-08
04719886908527USTAR II Knee SystemUNITED ORTHOPEDIC CORP.KRO2025-09-08