FDA.reportPublic FDA data

TRIATHLON

Primary DI
07613327558104
Brand
TRIATHLON
Company
Howmedica Osteonics Corp.
Model
5612-B-700
Catalog number
5612-B-700
Device description
Revision Tibial Baseplate
Published
2023-06-29
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07613327558104PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07613327558104076133275581047613327558104

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

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
07613327259797INSTRUMENT1100-2800R1100-2800R2016-09-24
07613327138078SOLAR5351-41085351-41082015-09-24
04546540167415EXETER0942-2-1100942-2-1102015-09-24
04546540167422EXETER0942-2-1120942-2-1122015-09-24
04546540167439EXETER0942-2-1140942-2-1142015-09-24
04546540167446EXETER0942-2-1160942-2-1162015-09-24
04546540167453EXETER0942-2-1180942-2-1182015-09-24
04546540167460EXETER0942-2-1200942-2-1202015-09-24
07613327245158INSTRUMENT6543-4-8186543-4-8182017-11-13
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

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