FDA.reportPublic FDA data

iTotal Identity 3DP Porous Knee

Primary DI
00840097515182
Brand
iTotal Identity 3DP Porous Knee
Company
Restor3d, Inc.
Model
TCR-000-SPEC-020121
Device description
iTotal Identity CR 3DP Porous Tibia Hybrid iJigs 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
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
00840097515182PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840097515182008400975151828400975151820840097515182

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
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
00840097514857Kinos Aeros Instrumentation5871-10312026-08-21
00840097514864Kinos Aeros Instrumentation5871-10322026-08-21
00840097514871Kinos Aeros Instrumentation5871-10332026-08-21
00840097514888Kinos Aeros Instrumentation5871-10342026-08-21
00840097514895Kinos Aeros Instrumentation5871-10352026-08-21
00840097514901Kinos Aeros Instrumentation5871-10462026-08-21
00840097514918Kinos Aeros Instrumentation5871-10472026-08-21
00840097515694Kinos Aeros Instrumentation5871-00722026-08-21
00840097515700Kinos Aeros Instrumentation5871-42012026-08-21
00840097515717Kinos Aeros Instrumentation5871-42022026-08-21
00840097533742Kinos Aeros Instrumentation5871-11542026-08-21
00840097533759Kinos Aeros Instrumentation5871-11592026-08-21

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
05404028000922SurgiCase PlannerMaterialise NVOOG2025-05-14
00885556779989VISIONAIRESmith & Nephew, Inc.OOG2021-09-22
00885556780039VISIONAIRESmith & Nephew, Inc.OOG2021-09-22
E314SURGICASEKNEEPLAN0SurgiCase PlannerMaterialise NVOOG2018-10-17
E314KNMCO0101010BespokeMATERIALISE USA, L.L.C.OOG2017-07-21
E314KNMCO0102010BespokeMATERIALISE USA, L.L.C.OOG2017-07-21
E314KNMCO0200010BespokeMATERIALISE USA, L.L.C.OOG2017-07-21
E314KNMCO0400010BespokeMATERIALISE USA, L.L.C.OOG2017-07-21
E314KNMLM0101010Lima PSIMaterialise NVOOG2017-07-21
E314KNMLM0102010Lima PSIMaterialise NVOOG2017-07-21
E314KNMLM0200010Lima PSIMaterialise NVOOG2017-07-21
E314KNMLM010101Lima PSIMaterialise NVOOG2016-12-01
E314KNMLM010201Lima PSIMaterialise NVOOG2016-12-01
E314KNMLM020001Lima PSIMaterialise NVOOG2016-12-01
E314KNMCO010101BespokeMATERIALISE USA, L.L.C.OOG2016-09-24
E314KNMCO010201BespokeMATERIALISE USA, L.L.C.OOG2016-09-24
E314KNMCO020001BespokeMATERIALISE USA, L.L.C.OOG2016-09-24
E314KNMCO040001BespokeMATERIALISE USA, L.L.C.OOG2016-09-24
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