FDA.reportPublic FDA data

Triathlon

Primary DI
07613327015539
Brand
Triathlon
Company
Howmedica Osteonics Corp.
Model
5620-B-302
Catalog number
5620-B-302
Device description
Tibial Baseplate
Published
2015-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
HRYPROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
HSXPROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER
KRRPROSTHESIS, KNEE, PATELLO/FEMORAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
NPJPROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HRYProsthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/PolymerOrthopedic2
HSXProsthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/PolymerOrthopedic2
KRRProsthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/PolymerOrthopedic2
NPJProsthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/PolymerOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K071881000
K082567000
K203099000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K071881000TRIATHLON PKR SYSTEMHowmedica Osteonics Corp.2007-10-09HRY
K082567000STRYKER COMPARTMENTAL KNEE SYSTEM LINE EXTENSIONHowmedica Osteonics Corp.2008-10-03HRY
K203099000Triathlon PKR SystemHowmedica Osteonics Corp. A.K.A. Stryker Orthopaedics2020-10-27HSX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07613327015539PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07613327015539076133270155397613327015539

GMDN Terms#

Term, Definition table
TermDefinition
Unicondylar knee prosthesisA sterile artificial substitute for the bearing surface of only one femoral condyle and corresponding tibial condyle of the knee (medial or lateral condyle) implanted during primary or revision knee replacement. It typically consists of femoral and tibial components and a knee insert which are made of metal or polyethylene (PE); fixation devices for implantation (e.g., screws) may be included and implantation may be performed with or without bone cement. The device is indicated in unicompartmental disease and/or damage (e.g., from arthritis) to the bearing surfaces of the knee.

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
07613327036503Triathlon5585-C-0165585-C-0162015-09-24
07613327036510Triathlon5585-C-0205585-C-0202015-09-24
07613327036527Triathlon5585-C-0255585-C-0252015-09-24
07613327036534Triathlon5585-C-0305585-C-0302015-09-24
07613327036541Triathlon5585-C-0355585-C-0352015-09-24
07613327036558Triathlon5585-C-0405585-C-0402015-09-24
07613327036565Triathlon5585-C-0455585-C-0452015-09-24
07613327036572Triathlon5585-C-0505585-C-0502015-09-24
07613327036589Triathlon5585-C-0555585-C-0552015-09-24
07613327036596Triathlon5585-C-0605585-C-0602015-09-24
07613327041071Triathlon5520-M-1005520-M-1002015-09-24
07613327041095Triathlon5520-M-2005520-M-2002015-09-24
07613327041101Triathlon5520-M-3005520-M-3002015-09-24
07613327041118Triathlon5520-M-4005520-M-4002015-09-24
07613327041125Triathlon5520-M-5005520-M-5002015-09-24
07613327041132Triathlon5520-M-6005520-M-6002015-09-24
07613327041149Triathlon5520-M-7005520-M-7002015-09-24
07613327041156Triathlon5520-M-8005520-M-8002015-09-24
07613327041392Triathlon5527-B-1005527-B-1002015-09-24
07613327041408Triathlon5527-B-3005527-B-3002015-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05404028001257SurgiCase PlannerMaterialise NVHSX2026-05-28
07613154557431INSTRUMENTHowmedica Osteonics Corp.HSX2016-09-24
07613154557431INSTRUMENTHowmedica Osteonics Corp.NPJ2016-09-24
07613154557431INSTRUMENTHowmedica Osteonics Corp.HRY2016-09-24
07613154557431INSTRUMENTHowmedica Osteonics Corp.KRR2016-09-24
07613327014549ScorpioHowmedica Osteonics Corp.HSX2015-09-24
07613327014549ScorpioHowmedica Osteonics Corp.HRY2015-09-24
07613327014549ScorpioHowmedica Osteonics Corp.NPJ2015-09-24
07613327014556ScorpioHowmedica Osteonics Corp.HRY2015-09-24
07613327014556ScorpioHowmedica Osteonics Corp.KRR2015-09-24
07613327014556ScorpioHowmedica Osteonics Corp.HSX2015-09-24
07613327014570ScorpioHowmedica Osteonics Corp.NPJ2015-09-24
07613327014570ScorpioHowmedica Osteonics Corp.HRY2015-09-24
07613327014570ScorpioHowmedica Osteonics Corp.HSX2015-09-24
07613327014587ScorpioHowmedica Osteonics Corp.NPJ2015-09-24
07613327014587ScorpioHowmedica Osteonics Corp.KRR2015-09-24
07613327014587ScorpioHowmedica Osteonics Corp.HRY2015-09-24
07613327014594ScorpioHowmedica Osteonics Corp.HRY2015-09-24
07613327014594ScorpioHowmedica Osteonics Corp.KRR2015-09-24
07613327014594ScorpioHowmedica Osteonics Corp.NPJ2015-09-24
07613327014600ScorpioHowmedica Osteonics Corp.NPJ2015-09-24
07613327014600ScorpioHowmedica Osteonics Corp.HSX2015-09-24
07613327014600ScorpioHowmedica Osteonics Corp.HRY2015-09-24
07613327015478TriathlonHowmedica Osteonics Corp.HSX2015-09-24
07613327015478TriathlonHowmedica Osteonics Corp.KRR2015-09-24
07613327015478TriathlonHowmedica Osteonics Corp.NPJ2015-09-24
07613327015492TriathlonHowmedica Osteonics Corp.HRY2015-09-24
07613327015492TriathlonHowmedica Osteonics Corp.NPJ2015-09-24
07613327015492TriathlonHowmedica Osteonics Corp.KRR2015-09-24
07613327015508TriathlonHowmedica Osteonics Corp.HRY2015-09-24