FDA.reportPublic FDA data

iUni® Unicondylar Knee Replacement System

Primary DI
M572UKA1111111011
Brand
iUni® Unicondylar Knee Replacement System
Company
Conformis, Inc.
Model
UKA111111101
Catalog number
UKA1111111
Device description
N/A
Published
2015-10-26
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HSXProsthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer
OOGKnee Arthroplasty Implantation System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HSXProsthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/PolymerOrthopedic2
OOGKnee Arthroplasty Implantation SystemOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K132640000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K132640000IUNI UNICONDYLAR KNEE REPLACEMENT SYSTEMConformis, Inc.2013-12-05HSX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M572UKA1111111011PrimaryHIBCC0

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

Contacts#

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

Regulatory Flags#

DUNS number
808821883
Device count
1
Serial number
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
00840097536705Identity CR KARestor3d, Inc.OOG2026-09-25
00840097536712Identity CR KARestor3d, Inc.OOG2026-09-25
00840097536729Identity CR KA 3DP PorousRestor3d, Inc.OOG2026-09-25
00840097536736Identity CR KA 3DP PorousRestor3d, Inc.OOG2026-09-25
00840097536743Identity CR KA 3DP PorousRestor3d, Inc.OOG2026-09-25
00840097536750Identity CR KA 3DP PorousRestor3d, Inc.OOG2026-09-25
00840097536767Identity CR KA 3DP PorousRestor3d, Inc.OOG2026-09-25
00840097536774Identity CR KA 3DP PorousRestor3d, Inc.OOG2026-09-25
00840097536781Identity CR KARestor3d, Inc.OOG2026-09-25
00840097536798Identity CR KARestor3d, Inc.OOG2026-09-25
00840097536804Identity CR KA 3DP PorousRestor3d, Inc.OOG2026-09-25
00840097536811Identity CR KA 3DP PorousRestor3d, Inc.OOG2026-09-25
E31442411410SignatureMaterialise NVOOG2026-09-24
E31442422415SignatureMaterialise NVOOG2026-09-24
E31442422450SignatureMaterialise NVOOG2026-09-24
E31442422451SignatureMaterialise NVOOG2026-09-24
E31442422452SignatureMaterialise NVOOG2026-09-24
E31442422453SignatureMaterialise NVOOG2026-09-24
E31442422455SignatureMaterialise NVOOG2026-09-24
E31442422456SignatureMaterialise NVOOG2026-09-24
E31442422457SignatureMaterialise NVOOG2026-09-24
E31442422458SignatureMaterialise NVOOG2026-09-24
E31442422460SignatureMaterialise NVOOG2026-09-24
E31442422461SignatureMaterialise NVOOG2026-09-24
E31442422462SignatureMaterialise NVOOG2026-09-24
E31442422463SignatureMaterialise NVOOG2026-09-24
E31442422465SignatureMaterialise NVOOG2026-09-24
E31442422466SignatureMaterialise NVOOG2026-09-24
E31442422467SignatureMaterialise NVOOG2026-09-24
E31442422468SignatureMaterialise NVOOG2026-09-24