FDA.reportPublic FDA data

iTotal Identity 3DP Porous Knee

Primary DI
00840097515199
Brand
iTotal Identity 3DP Porous Knee
Company
Restor3d, Inc.
Model
TCR-000-SPEC-010131
Device description
iTotal Identity CR 3DP Porous Femur 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
00840097515199PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840097515199008400975151998400975151990840097515199

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
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
00840097533995Veritas Hemiarthroplasty1510-50212026-09-18
00840097534008Veritas Hemiarthroplasty1510-52202026-09-18
00840097534015Veritas Hemiarthroplasty1510-52232026-09-18
00840097534022Veritas Hemiarthroplasty4530-10012026-09-18
00840097513201Velora Acetabular System InstrumentationED-06105-C022026-08-21
00840097514789Kinos Aeros Instrumentation5871-00152026-08-21
00840097514796Kinos Aeros Instrumentation5871-00742026-08-21
00840097514802Kinos Aeros Instrumentation5871-00762026-08-21
00840097514819Kinos Aeros Instrumentation5871-00782026-08-21
00840097514826Kinos Aeros Instrumentation5871-09022026-08-21
00840097514833Kinos Aeros Instrumentation5871-09202026-08-21
00840097514840Kinos Aeros Instrumentation5871-09212026-08-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
E31442422470SignatureMaterialise NVOOG2026-09-24
E31442422471SignatureMaterialise NVOOG2026-09-24
E31442422472SignatureMaterialise NVOOG2026-09-24
E31442422473SignatureMaterialise NVOOG2026-09-24
E31442422475SignatureMaterialise NVOOG2026-09-24
E31442422476SignatureMaterialise NVOOG2026-09-24
E31442422477SignatureMaterialise NVOOG2026-09-24
E31442422478SignatureMaterialise NVOOG2026-09-24
E31442422650SignatureMaterialise NVOOG2026-09-24
E31442422651SignatureMaterialise NVOOG2026-09-24
E31442422652SignatureMaterialise NVOOG2026-09-24
E31442422653SignatureMaterialise NVOOG2026-09-24