FDA.reportPublic FDA data

ITOTAL PATELLA TRIAL 44MM ROUND DOME

Primary DI
00810933030391
Brand
ITOTAL PATELLA TRIAL 44MM ROUND DOME
Company
Conformis, Inc.
Model
1080-229
Published
2019-09-27
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OIYProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive
OOGKnee Arthroplasty Implantation System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OIYProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + AdditiveOrthopedic2
OOGKnee Arthroplasty Implantation SystemOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810933030391PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810933030391008109330303918109330303910810933030391

GMDN Terms#

Term, Definition table
TermDefinition
Patella prosthesis trialA copy of a final patella prosthesis designed to be used during unicompartmental knee replacement surgery or total knee arthroplasty (TKA) to determine the correct alignment, size, and fit of the final prosthesis, and to check that patellar ligament balancing is correct. It is one of a set, or a set, of graduated sizes and is typically made of metal and/or polymer. This is a reusable device intended to be sterilized prior to use.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Outer Diameter44Millimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
781-345-9001customer-service@conformis.com

Regulatory Flags#

DUNS number
808821883
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810933031114Cordera Hip System Offset Cup Impactor, Enztec1080-6461080-6462022-03-07
00810933031183Cordera Hip System Radel Liner Impactors 28mm1080-6551080-6552022-03-07
00810933031190Cordera Hip System Radel Liner Impactors 32mm1080-6561080-6562022-03-07
00810933031206Cordera Hip System Radel Liner Impactors 36mm1080-6571080-6572022-03-07
00810933031213Cordera Hip System Radel Liner Impactors 40mm1080-6581080-6582022-03-07
00810933031220Cordera Hip System T-handle Quick Connect1080-6591080-6592022-03-07
00810933031237Cordera Hip System OrthoGroup Cup Impactor1080-6601080-6602022-03-07
00850268007187iTotal® Impactor Head1080-5412016-10-24
00850268007194iTotal® Impactor Head1080-5352016-10-24
00850268007200iTotal® CR Tibial Tray Impactor Tip1080-5362016-10-24
00850268007217iTotal® PS Tibial Tray Impactor Tip1080-5422016-10-24
00850268007224iTotal® Poly Impactor Tip1080-5242016-10-24
M572HDL060C24S011iTotal® Hip Replacement SystemHDL060C24S01HDL060C24S2018-08-06
M572HDL060D24S011iTotal® Hip Replacement SystemHDL060D24S01HDL060D24S2018-07-30
M572HDL060D34S011iTotal® Hip Replacement SystemHDL060D34S01HDL060D34S2018-08-06
M572HDL060E24S011iTotal® Hip Replacement SystemHDL060E24S01HDL060E24S2018-08-06
M572HDL060E34S011iTotal® Hip Replacement SystemHDL060E34S01HDL060E34S2018-08-06
M572HDL060F24S011iTotal® Hip Replacement SystemHDL060F24S01HDL060F24S2018-08-06
M572HDL060F34S011iTotal® Hip Replacement SystemHDL060F34S01HDL060F34S2018-08-06
M572HDL060C10S011iTotal® Hip Replacement SystemHDL060C10S01HDL060C10S2018-08-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07630030891595My Knee Femoral Cutting BlocksMedacta International SAOOG2023-09-13
07630030868047My KneeMedacta International SAOOG2021-07-05
07630030868023My Knee Femoral Cutting BlocksMedacta International SAOOG2021-06-25
08800068942272EXULT Knee Replacement SystemCorentec Co., LtdOOG2020-08-17
08800068942289EXULT Knee Replacement SystemCorentec Co., LtdOOG2020-08-17
08800068942296EXULT Knee Replacement SystemCorentec Co., LtdOOG2020-08-17
08800068942302EXULT Knee Replacement SystemCorentec Co., LtdOOG2020-08-17
08800068942319EXULT Knee Replacement SystemCorentec Co., LtdOOG2020-08-17
08428898831216BIOMET KNEE SYSTEMBiomet Orthopedics, LLCOIY2015-10-24
08428898831230BIOMET KNEE SYSTEMBiomet Orthopedics, LLCOIY2015-10-24
08428898831209BIOMET KNEE SYSTEMBiomet Orthopedics, LLCOIY2015-10-24
08428898831223BIOMET KNEE SYSTEMBiomet Orthopedics, LLCOIY2015-10-24
07630030847868My Knee Femoral Cutting BlocksMedacta International SAOOG2014-11-18
07630030847875My Knee Femoral Cutting BlocksMedacta International SAOOG2014-11-18
07630030847905My Knee Femoral Cutting BlocksMedacta International SAOOG2014-11-18
07630030847912My Knee Femoral Cutting BlocksMedacta International SAOOG2014-11-18
07630030847943My Knee Femoral Cutting BlocksMedacta International SAOOG2014-11-18
07630030847950My Knee Femoral Cutting BlocksMedacta International SAOOG2014-11-18
07630030847981My Knee Femoral Cutting BlocksMedacta International SAOOG2014-11-18
07630030847998My Knee Femoral Cutting BlocksMedacta International SAOOG2014-11-18
07630030848025My Knee Femoral Cutting BlocksMedacta International SAOOG2014-11-18
07630030848032My Knee Femoral Cutting BlocksMedacta International SAOOG2014-11-18
07630030848063My Knee Femoral Cutting BlocksMedacta International SAOOG2014-11-18
07630030848070My Knee Femoral Cutting BlocksMedacta International SAOOG2014-11-18
07630030848100My Knee Femoral Cutting BlocksMedacta International SAOOG2014-11-18
07630030848117My Knee Femoral Cutting BlocksMedacta International SAOOG2014-11-18
07630030848131My Knee Tibial Cutting BlocksMedacta International SAOOG2014-11-18
07630030848162My Knee Tibial Cutting BlocksMedacta International SAOOG2014-11-18
07630030848179My Knee Tibial Cutting BlocksMedacta International SAOOG2014-11-18
07630030848209My Knee Tibial Cutting BlocksMedacta International SAOOG2014-11-18