FDA.reportPublic FDA data

INSTRUMENT

Primary DI
07613327303674
Brand
INSTRUMENT
Company
Howmedica Osteonics Corp.
Model
I-K2715KF04
Catalog number
I-K2715KF04
Device description
SPECIALTY TRIATHLON EXPRESS DOWNSIZE 4IN1 RECUT BLOCK
Published
2016-11-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
JWHPROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
MBHPROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/PolymerOrthopedic2
MBHProsthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/PolymerOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K143393000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K143393000Triathlon Tritanium Cone AugmentsStryker Orthopaedics2015-01-13MBH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07613327303674PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07613327303674076133273036747613327303674

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic prosthesis implantation instrument, reusableA hand-held surgical instrument intended to be used during implantation of an orthopaedic prosthesis, either manually or as a computer-assisted surgery (CAS) device, to aid in the navigation/placement of the prosthesis or other instruments. It may be used for the following applications: 1) to hold/align/fix bone preparation instruments, prosthesis, or prosthesis component; 2) to provide relative position landmarks; 3) to ascertain correct spatial orientation or limb alignment; and/or 4) as an interface between prosthesis components. This is a reusable device intended to be sterilized prior to use.

Device Sizes#

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

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
058311945
Device count
1
Lot or batch
true
Sterilization required before use
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
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00843575106476MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.JWH2026-05-29
00843575106483MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.JWH2026-05-29
00843575106490MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.JWH2026-05-29
00843575106506MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.JWH2026-05-29
00843575106513MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.JWH2026-05-29
00843575106520MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.JWH2026-05-29
00843575106537MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.JWH2026-05-29
00843575106544MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.JWH2026-05-29
00843575106551MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.JWH2026-05-29
00843575106568MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.JWH2026-05-29
00843575106575MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.JWH2026-05-29
00843575106582MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.JWH2026-05-29
00843575106599MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.JWH2026-05-29
00843575107619MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.JWH2026-05-29
00843575107626MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.JWH2026-05-29
00843575107633MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.JWH2026-05-29
00843575107640MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.JWH2026-05-29
00843575107657MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.JWH2026-05-29
00843575107664MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.JWH2026-05-29
00843575107671MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.JWH2026-05-29
00843575107688MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.JWH2026-05-29
00843575107695MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.JWH2026-05-29
00843575107701MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.JWH2026-05-29
00843575107718MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.JWH2026-05-29
00843575107725MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.JWH2026-05-29
00843575107732MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.JWH2026-05-29
00843575107749MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.JWH2026-05-29