FDA.report

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
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
OOGKnee Arthroplasty Implantation System

Product Code Classifications

CodeDeviceSpecialtyClass
OOGKnee Arthroplasty Implantation SystemOrthopedic2

Premarket Submissions

SubmissionSupplement
K243768000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K243768000iTotal® Identity™ Cruciate Retaining 3DP Porous Knee Replacement SystemRestor3D, Inc.2025-03-27MBH

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00840097515175PrimaryGS10

GMDN Terms

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

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 DIBrandModelCatalogPublished
00840097534947Total Knee Instrumentation 5201-10012025-10-10
00840097534954Total Knee Instrumentation 5201-10022025-10-10
00840097534961Total Knee Instrumentation 5201-10032025-10-10
00840097513256Ossera™ AFX Instrumentation5740-00012025-12-18
00840097513263Ossera™ AFX Instrumentation5740-00022025-12-18
00840097513270Ossera™ AFX Instrumentation5740-00032025-12-18
00840097513287Ossera™ AFX Instrumentation5740-34262025-12-18
00840097515724Ossera™ AFX Instrumentation5740-34362025-12-18
00840097515731Ossera™ AFX Instrumentation5740-34402025-12-18
00840097519333Ossera™ AFX1740-34262025-12-18
00840097519340Ossera™ AFX1740-34362025-12-18
00840097519357Ossera™ AFX1740-36322025-12-18
00840097519364Ossera™ AFX1740-36422025-12-18
00840097519371Ossera™ AFX1740-40362025-12-18
00840097519388Ossera™ AFX1740-40462025-12-18
00840097532370Ossera™ AFX Instrumentation5740-36322025-12-18
00840097532387Ossera™ AFX Instrumentation5740-36362025-12-18
00840097533599Ossera™ AFX Instrumentation5741-24012025-12-18
00840097533612Ossera™ AFX Instrumentation5741-34012025-12-18
00840097533629Ossera™ AFX Instrumentation5741-36012025-12-18

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
TKRL000191I00PointCloud Knee InstrumentsUnik Orthopedics Inc.OOG2026-03-03
TKRL0001B2750PointCloud Knee InstrumentsUnik Orthopedics Inc.OOG2026-03-03
TKRL0001B4030PointCloud Knee InstrumentsUnik Orthopedics Inc.OOG2026-03-03
TKRL0001B46I0PointCloud Knee InstrumentsUnik Orthopedics Inc.OOG2026-03-03
TKRL0001BB6K0PointCloud Knee InstrumentsUnik Orthopedics Inc.OOG2026-03-03
TKRL0001BDK40PointCloud Knee InstrumentsUnik Orthopedics Inc.OOG2026-03-03
TKRL0001I84D0PointCloud Knee InstrumentsUnik Orthopedics Inc.OOG2026-03-03
TKRL0001I9130PointCloud Knee InstrumentsUnik Orthopedics Inc.OOG2026-03-03
TKRL0001I9D80PointCloud Knee InstrumentsUnik Orthopedics Inc.OOG2026-03-03
TKRL0001IB6D0PointCloud Knee InstrumentsUnik Orthopedics Inc.OOG2026-03-03
TKRL0001III50PointCloud Knee InstrumentsUnik Orthopedics Inc.OOG2026-03-03
TKRL0001IL240PointCloud Knee InstrumentsUnik Orthopedics Inc.OOG2026-03-03
00889024704442Vanguard XP® Complete Knee SystemBiomet Orthopedics, LLCOOG2025-12-23
00840097515151iTotal Identity 3DP Porous KneeRestor3d, Inc.OOG2025-12-02
00840097515168iTotal Identity 3DP Porous KneeRestor3d, Inc.OOG2025-12-02
00840097515182iTotal Identity 3DP Porous KneeRestor3d, Inc.OOG2025-12-02
00840097515199iTotal Identity 3DP Porous KneeRestor3d, Inc.OOG2025-12-02
00840097515205iTotal Identity 3DP Porous KneeRestor3d, Inc.OOG2025-12-02
07630345783677My Knee Bone ModelsMedacta International SAOOG2025-07-03
TKRL000144II0PointCloud Knee InstrumentsUnik Orthopedics Inc.OOG2025-06-18
TKRL0001494K0PointCloud Knee InstrumentsUnik Orthopedics Inc.OOG2025-06-18
TKRL00014KL00PointCloud Knee InstrumentsUnik Orthopedics Inc.OOG2025-06-18
TKRL00014L0K0PointCloud Knee InstrumentsUnik Orthopedics Inc.OOG2025-06-18
TKRL000151910PointCloud Knee InstrumentsUnik Orthopedics Inc.OOG2025-06-18
TKRL000151F5PointCloud Knee InstrumentsUnik Orthopedics Inc.OOG2025-06-18
TKRL000152B8PointCloud Knee InstrumentsUnik Orthopedics Inc.OOG2025-06-18
TKRL000153830PointCloud Knee InstrumentsUnik Orthopedics Inc.OOG2025-06-18
TKRL000155150PointCloud Knee InstrumentsUnik Orthopedics Inc.OOG2025-06-18
TKRL00015694PointCloud Knee InstrumentsUnik Orthopedics Inc.OOG2025-06-18
TKRL0001576F0PointCloud Knee InstrumentsUnik Orthopedics Inc.OOG2025-06-18