FDA.reportPublic FDA data

iTotal Identity 3DP Porous Knee

Primary DI
00840097515113
Brand
iTotal Identity 3DP Porous Knee
Company
Restor3d, Inc.
Model
PAT-012-3510
Device description
iTotal Identity 3DP Porous Round Patella 35mm x 10mm
Published
2025-12-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
JWKAntigen, Positive Control, Cryptococcus Neoformans
MBHProsthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
OIYProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive
OOGKnee Arthroplasty Implantation System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JWKAntigen, Positive Control, Cryptococcus NeoformansMicrobiology2
MBHProsthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/PolymerOrthopedic2
OIYProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + AdditiveOrthopedic2
OOGKnee Arthroplasty Implantation SystemOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K243768000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K243768000iTotal® Identity™ Cruciate Retaining 3DP Porous Knee Replacement SystemRestor3D, Inc.2025-03-27MBH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840097515113PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840097515113008400975151138400975151130840097515113

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
080819836
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840097503677Veritas Instrumentation6500-11202026-10-16
00840097536705Identity CR KA5253-0001TCR-000- D0012026-09-25
00840097536712Identity CR KA5253-0002TCR-000- D0012026-09-25
00840097536729Identity CR KA 3DP Porous5253-0031TCR-000-D0052026-09-25
00840097536736Identity CR KA 3DP Porous5253-0032TCR-000-D0052026-09-25
00840097536743Identity CR KA 3DP Porous5253-0021TCR-000-SPEC2026-09-25
00840097536750Identity CR KA 3DP Porous5253-0011TCR-000-SPEC2026-09-25
00840097536767Identity CR KA 3DP Porous5253-0022TCR-000-SPEC2026-09-25
00840097536774Identity CR KA 3DP Porous5253-0012TCR-000-SPEC2026-09-25
00840097536781Identity CR KA5253-0901TCR-000-D0012026-09-25
00840097536798Identity CR KA5253-0902TCR-000-D0012026-09-25
00840097536804Identity CR KA 3DP Porous5253-0933TCR-000-D0052026-09-25
00840097536811Identity CR KA 3DP Porous5253-0934TCR-000-D0052026-09-25
00840097533919Veritas Hemiarthroplasty1508-10012026-09-18
00840097533926Veritas Hemiarthroplasty1510-38142026-09-18
00840097533933Veritas Hemiarthroplasty1510-40152026-09-18
00840097533940Veritas Hemiarthroplasty1510-42162026-09-18
00840097533957Veritas Hemiarthroplasty1510-44172026-09-18
00840097533964Veritas Hemiarthroplasty1510-46182026-09-18
00840097533971Veritas Hemiarthroplasty1510-48182026-09-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05056139247750Unity Total Knee SystemCORIN LTDOIY2026-10-23
05056139247804Unity Total Knee SystemCORIN LTDOIY2026-10-23
05056139247811Unity Total Knee SystemCORIN LTDOIY2026-10-23
05056139247828Unity Total Knee SystemCORIN LTDOIY2026-10-23
05056139247835Unity Total Knee SystemCORIN LTDOIY2026-10-23
05056139247941Unity Total Knee SystemCORIN LTDOIY2026-10-23
05056139247958Unity Total Knee SystemCORIN LTDOIY2026-10-23
05056139247965Unity Total Knee SystemCORIN LTDOIY2026-10-23
05056139247972Unity Total Knee SystemCORIN LTDOIY2026-10-23
05056139247989Unity Total Knee SystemCORIN LTDOIY2026-10-23
05056139248047Unity Total Knee SystemCORIN LTDOIY2026-10-23
05056139248054Unity Total Knee SystemCORIN LTDOIY2026-10-23
05056139248061Unity Total Knee SystemCORIN LTDOIY2026-10-23
05056139248078Unity Total Knee SystemCORIN LTDOIY2026-10-23
05056139248085Unity Total Knee SystemCORIN LTDOIY2026-10-23
05056139248146Unity Total Knee SystemCORIN LTDOIY2026-10-23
05056139248153Unity Total Knee SystemCORIN LTDOIY2026-10-23
05056139248160Unity Total Knee SystemCORIN LTDOIY2026-10-23
05056139248177Unity Total Knee SystemCORIN LTDOIY2026-10-23
05056139248184Unity Total Knee SystemCORIN LTDOIY2026-10-23
05056139248597Unity Total Knee SystemCORIN LTDOIY2026-10-23
05056139249013Unity Total Knee SystemCORIN LTDOIY2026-10-23
05056139249020Unity Total Knee SystemCORIN LTDOIY2026-10-23
05056139249037Unity Total Knee SystemCORIN LTDOIY2026-10-23
05056139249044Unity Total Knee SystemCORIN LTDOIY2026-10-23
05056139249303Unity Total Knee SystemCORIN LTDOIY2026-10-23
05056139249310Unity Total Knee SystemCORIN LTDOIY2026-10-23
05056139249327Unity Total Knee SystemCORIN LTDOIY2026-10-23
05056139249334Unity Total Knee SystemCORIN LTDOIY2026-10-23
05056139249341Unity Total Knee SystemCORIN LTDOIY2026-10-23