FDA.reportPublic FDA data

iTotal® iPoly XE™ Patella

Primary DI
M572PAT0212906011
Brand
iTotal® iPoly XE™ Patella
Company
Conformis, Inc.
Model
PAT021290601
Catalog number
PAT0212906
Device description
N/A
Published
2015-10-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
OIYProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/PolymerOrthopedic2
OIYProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + AdditiveOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K142161000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K142161000ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM, ITOTAL POSTERIOR STABILIZED (PS) KNEE REPLACEMENT SYSTEMConformis, Inc.2014-11-14JWH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M572PAT0212906011PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Polyethylene patella prosthesisAn implantable device made of polyethylene (PE) intended to fully or partially replace the patella (kneecap) as part of a bicondylar knee joint replacement (primary or revision). It is designed to articulate with a prosthetic distal femoral component by attachment to the back of the natural patella with or without bone cement.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Outer Diameter29Millimeter

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
808821883
Device count
1
Lot or batch
true
Expiration date on label
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
00885556923023NASmith & Nephew, Inc.JWH2026-07-16
08800017262819EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262826EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262833EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262840EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262857EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262864EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262871EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262888EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262895EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262901EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262918EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262925EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262932EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262949EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262956EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262963EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262970EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262987EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262994EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017263007EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017263014EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017263021EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017263038EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017263045EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017263052EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017263069EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017263076EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017263083EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017263090EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10