FDA.reportPublic FDA data

INSTRUMENT

Primary DI
07613327250008
Brand
INSTRUMENT
Company
Howmedica Osteonics Corp.
Model
5565-T-017A
Catalog number
5565-T-017A
Device description
METAL STEM TRIAL TRIATHLON INSTRUMENTS
Published
2016-09-24
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
K132624000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K132624000TRIATHLON TRITANIUM METAL-BACKED PATELLAStryker Orthopaedics2013-11-26MBH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07613327250008PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07613327250008076133272500087613327250008

GMDN Terms#

Term, Definition table
TermDefinition
Femoral stem prosthesis trialA copy of a final femoral stem prosthesis designed to be used for trial reductions during hip arthroplasty to judge the correct offset, leg-length, and range of motion of the final femoral prosthesis to be implanted. It is one of a set, or a set, of graduated sizes, and is used in conjunction with femoral head trial prostheses. It is typically made of metal or polymer material and includes trial stems, trial sleeves, and trial necks. This is a reusable device intended to be sterilized prior to use.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0
Length100Millimeter

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
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
00840097536552iTotal Identity CR 3DP PorousRestor3d, Inc.MBH2026-07-31
00840097536552iTotal Identity CR 3DP PorousRestor3d, Inc.JWH2026-07-31
00840097536569iTotal Identity CR 3DP PorousRestor3d, Inc.JWH2026-07-31
00840097536569iTotal Identity CR 3DP PorousRestor3d, Inc.MBH2026-07-31
00840097536576iTotal Identity CR 3DP PorousRestor3d, Inc.JWH2026-07-31
00840097536576iTotal Identity CR 3DP PorousRestor3d, Inc.MBH2026-07-31
00840097536583iTotal Identity CR 3DP PorousRestor3d, Inc.JWH2026-07-31
00840097536583iTotal Identity CR 3DP PorousRestor3d, Inc.MBH2026-07-31
00840097536590iTotal Identity CR 3DP PorousRestor3d, Inc.JWH2026-07-31
00840097536590iTotal Identity CR 3DP PorousRestor3d, Inc.MBH2026-07-31
03701089509695AMPLITUDEAMPLITUDE SASJWH2026-07-31
03701089517492TRAXAMPLITUDE SASJWH2026-07-29
03701089517508TRAXAMPLITUDE SASJWH2026-07-29
03701089517515TRAXAMPLITUDE SASJWH2026-07-29
03701089517522TRAXAMPLITUDE SASJWH2026-07-29
03701089517539TRAXAMPLITUDE SASJWH2026-07-29
03701089517546TRAXAMPLITUDE SASJWH2026-07-29
03701089517553TRAXAMPLITUDE SASJWH2026-07-29
03701089517560TRAXAMPLITUDE SASJWH2026-07-29
03701089517577TRAXAMPLITUDE SASJWH2026-07-29
03701089517584TRAXAMPLITUDE SASJWH2026-07-29
03701089517591TRAXAMPLITUDE SASJWH2026-07-29
03701089517607TRAXAMPLITUDE SASJWH2026-07-29
03701089517614TRAXAMPLITUDE SASJWH2026-07-29
03701089517621TRAXAMPLITUDE SASJWH2026-07-29
03701089517638TRAXAMPLITUDE SASJWH2026-07-29
03701089517645TRAXAMPLITUDE SASJWH2026-07-29
03701089517652TRAXAMPLITUDE SASJWH2026-07-29
03701089517669TRAXAMPLITUDE SASJWH2026-07-29
03701089518390TRAXAMPLITUDE SASJWH2026-07-29