FDA.reportPublic FDA data

Identity CR KA 3DP Porous

Primary DI
00840097536767
Brand
Identity CR KA 3DP Porous
Company
Restor3d, Inc.
Model
5253-0022
Catalog number
TCR-000-SPEC
Device description
IDENTITY CR KA IJIGS, HYBRID TIBIA, RIGHT
Published
2026-09-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
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
00840097536767PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840097536767008400975367678400975367670840097536767

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.

Regulatory Flags#

DUNS number
080819836
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
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
05056139247712Unity Total Knee SystemCORIN LTDOIY2026-10-19
05056139247712Unity Total Knee SystemCORIN LTDJWH2026-10-19
05056139247729Unity Total Knee SystemCORIN LTDOIY2026-10-19
05056139247729Unity Total Knee SystemCORIN LTDJWH2026-10-19
05056139247736Unity Total Knee SystemCORIN LTDOIY2026-10-19
05056139247736Unity Total Knee SystemCORIN LTDJWH2026-10-19
05056139247743Unity Total Knee SystemCORIN LTDJWH2026-10-19
05056139247743Unity Total Knee SystemCORIN LTDOIY2026-10-19
05056139247767Unity Total Knee SystemCORIN LTDJWH2026-10-19
05056139247767Unity Total Knee SystemCORIN LTDOIY2026-10-19
05056139247774Unity Total Knee SystemCORIN LTDJWH2026-10-19
05056139247774Unity Total Knee SystemCORIN LTDOIY2026-10-19
05056139247781Unity Total Knee SystemCORIN LTDJWH2026-10-19
05056139247781Unity Total Knee SystemCORIN LTDOIY2026-10-19
05056139247798Unity Total Knee SystemCORIN LTDOIY2026-10-19
05056139247798Unity Total Knee SystemCORIN LTDJWH2026-10-19
05056139247897Unity Total Knee SystemCORIN LTDOIY2026-10-19
05056139247897Unity Total Knee SystemCORIN LTDJWH2026-10-19
05056139247903Unity Total Knee SystemCORIN LTDJWH2026-10-19
05056139247903Unity Total Knee SystemCORIN LTDOIY2026-10-19
05056139247910Unity Total Knee SystemCORIN LTDJWH2026-10-19
05056139247910Unity Total Knee SystemCORIN LTDOIY2026-10-19
05056139247927Unity Total Knee SystemCORIN LTDJWH2026-10-19
05056139247927Unity Total Knee SystemCORIN LTDOIY2026-10-19
05056139247934Unity Total Knee SystemCORIN LTDJWH2026-10-19
05056139247934Unity Total Knee SystemCORIN LTDOIY2026-10-19
05056139247996Unity Total Knee SystemCORIN LTDJWH2026-10-19
05056139247996Unity Total Knee SystemCORIN LTDOIY2026-10-19
05056139248009Unity Total Knee SystemCORIN LTDOIY2026-10-19
05056139248009Unity Total Knee SystemCORIN LTDJWH2026-10-19