FDA.reportPublic FDA data

iTotal Identity 3DP Porous Knee

Primary DI
00840097515175
Brand
iTotal Identity 3DP Porous Knee
Company
Restor3d, Inc.
Model
TCR-000-SPEC-010121
Device description
iTotal Identity CR 3DP Porous Tibia Hybrid iJigs Left
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
OOGKnee Arthroplasty Implantation System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
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
00840097515175PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840097515175008400975151758400975151750840097515175

GMDN Terms#

Term, Definition table
TermDefinition
Total knee prosthesis implantation guide-instrument kitA collection of sterile hand-held surgical instruments intended to be used during total knee arthroplasty (TKA), either manually or as a computer-assisted surgery (CAS) device, to aid in the navigation/placement of the prosthesis or other instruments. Components may be used for the following applications: 1) to hold/align/fix bone preparation instruments, prosthesis, or prosthesis component; 2) to provide relative position landmarks; 3) to ascertain correct spatial orientation or limb alignment; and/or 4) as an interface between prosthesis components; the implant is not included. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840097513768Ossera™ AFX1741-4600-N2025-05-20
00840097517193Ossera™ AFX1741-3400-N2025-05-20
00840097517209Ossera™ AFX1741-3600-N2025-05-20
00840097517216Ossera™ AFX1741-3800-N2025-05-20
00840097517223Ossera™ AFX1741-4000-N2025-05-20
00840097517230Ossera™ AFX1741-4200-N2025-05-20
00840097517247Ossera™ AFX1741-4400-N2025-05-20
00840097517254Ossera™ AFX1742-3434-N2025-05-20
00840097517261Ossera™ AFX1742-3436-N2025-05-20
00840097517278Ossera™ AFX1742-3438-N2025-05-20
00840097517285Ossera™ AFX1742-3440-N2025-05-20
00840097517292Ossera™ AFX1742-3442-N2025-05-20
00840097517308Ossera™ AFX1742-3444-N2025-05-20
00840097517315Ossera™ AFX1742-3446-N2025-05-20
00840097517322Ossera™ AFX1742-3634-N2025-05-20
00840097517339Ossera™ AFX1742-3636-N2025-05-20
00840097517346Ossera™ AFX1742-3638-N2025-05-20
00840097517353Ossera™ AFX1742-3640-N2025-05-20
00840097517360Ossera™ AFX1742-3642-N2025-05-20
00840097517377Ossera™ AFX1742-3644-N2025-05-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840097536552iTotal Identity CR 3DP PorousRestor3d, Inc.OOG2026-07-31
00840097536569iTotal Identity CR 3DP PorousRestor3d, Inc.OOG2026-07-31
00840097536576iTotal Identity CR 3DP PorousRestor3d, Inc.OOG2026-07-31
00840097536583iTotal Identity CR 3DP PorousRestor3d, Inc.OOG2026-07-31
00840097536590iTotal Identity CR 3DP PorousRestor3d, Inc.OOG2026-07-31
05404028001257SurgiCase PlannerMaterialise NVOOG2026-05-28
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
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