FDA.reportPublic FDA data

iTotal Identity 3DP Porous Knee

Primary DI
00840097515076
Brand
iTotal Identity 3DP Porous Knee
Company
Restor3d, Inc.
Model
TCR-102-1112-020101
Device description
iTotal Identity CR 3DP Porous Femoral Implant Right
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
JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
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
JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/PolymerOrthopedic2
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
00840097515076PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840097515076008400975150768400975150760840097515076

GMDN Terms#

Term, Definition table
TermDefinition
Coated knee femur prosthesisA sterile implantable device designed to replace the femoral condyles (femoral component) during primary bicondylar replacement of the knee joint or to replace a dysfunctional knee prosthesis (revision); it is made of metal [e.g., cobalt-chrome (Co-Cr)] and is coated with a material (e.g., beads, hydroxyapatite, mesh) intended to improve fixation and stability by promoting bone ingrowth. The device is designed to articulate with tibial and, if required, patellar prosthetic components of the knee joint and its implantation may be performed with or without bone cement.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
080819836
Device count
1
Serial number
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
00840097533988Veritas Hemiarthroplasty1510-50192026-09-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840097536705Identity CR KARestor3d, Inc.OIY2026-09-25
00840097536705Identity CR KARestor3d, Inc.JWH2026-09-25
00840097536705Identity CR KARestor3d, Inc.OOG2026-09-25
00840097536712Identity CR KARestor3d, Inc.OOG2026-09-25
00840097536712Identity CR KARestor3d, Inc.OIY2026-09-25
00840097536712Identity CR KARestor3d, Inc.JWH2026-09-25
00840097536729Identity CR KA 3DP PorousRestor3d, Inc.OOG2026-09-25
00840097536729Identity CR KA 3DP PorousRestor3d, Inc.OIY2026-09-25
00840097536729Identity CR KA 3DP PorousRestor3d, Inc.JWH2026-09-25
00840097536729Identity CR KA 3DP PorousRestor3d, Inc.MBH2026-09-25
00840097536736Identity CR KA 3DP PorousRestor3d, Inc.OOG2026-09-25
00840097536736Identity CR KA 3DP PorousRestor3d, Inc.OIY2026-09-25
00840097536736Identity CR KA 3DP PorousRestor3d, Inc.JWH2026-09-25
00840097536736Identity CR KA 3DP PorousRestor3d, Inc.MBH2026-09-25
00840097536743Identity CR KA 3DP PorousRestor3d, Inc.OIY2026-09-25
00840097536743Identity CR KA 3DP PorousRestor3d, Inc.MBH2026-09-25
00840097536743Identity CR KA 3DP PorousRestor3d, Inc.JWH2026-09-25
00840097536743Identity CR KA 3DP PorousRestor3d, Inc.OOG2026-09-25
00840097536750Identity CR KA 3DP PorousRestor3d, Inc.OOG2026-09-25
00840097536750Identity CR KA 3DP PorousRestor3d, Inc.OIY2026-09-25
00840097536750Identity CR KA 3DP PorousRestor3d, Inc.JWH2026-09-25
00840097536750Identity CR KA 3DP PorousRestor3d, Inc.MBH2026-09-25
00840097536767Identity CR KA 3DP PorousRestor3d, Inc.OOG2026-09-25
00840097536767Identity CR KA 3DP PorousRestor3d, Inc.OIY2026-09-25
00840097536767Identity CR KA 3DP PorousRestor3d, Inc.JWH2026-09-25
00840097536767Identity CR KA 3DP PorousRestor3d, Inc.MBH2026-09-25
00840097536774Identity CR KA 3DP PorousRestor3d, Inc.OOG2026-09-25
00840097536774Identity CR KA 3DP PorousRestor3d, Inc.OIY2026-09-25
00840097536774Identity CR KA 3DP PorousRestor3d, Inc.JWH2026-09-25
00840097536774Identity CR KA 3DP PorousRestor3d, Inc.MBH2026-09-25