FDA.reportPublic FDA data

iTotal Identity 3DP Porous Knee

Primary DI
00840097515151
Brand
iTotal Identity 3DP Porous Knee
Company
Restor3d, Inc.
Model
TCR-000-D005-010111
Device description
iTotal Identity CR 3DP Porous 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
00840097515151PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840097515151008400975151518400975151510840097515151

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
00840097503011restor3d Osteotomy Wedge1100-002-221409072021-09-01
00840097503028restor3d Osteotomy Wedge1100-002-221410072021-09-01
00840097503073restor3d Osteotomy Wedge1100-002-221405072021-09-01
00840097503080restor3d Osteotomy Wedge1100-002-221406072021-09-01
00840097503097restor3d Osteotomy Wedge1100-002-221407072021-09-01
00840097503103restor3d Osteotomy Wedge1100-002-221408072021-09-01
00840097504674restor3d Osteotomy Wedge1100-002-221405102022-08-18
00840097504681restor3d Osteotomy Wedge1100-002-221406132022-08-18
00840097504698restor3d Osteotomy Wedge1100-002-221407152022-08-18
00840097504704restor3d Osteotomy Wedge1100-002-221408182022-08-18
00840097504711restor3d Osteotomy Wedge1100-002-221410232022-08-18
00840097504728restor3d Osteotomy Wedge1100-002-221412282022-08-18
00840097504735restor3d Osteotomy Wedge1100-002-181205132022-08-18
00840097504742restor3d Osteotomy Wedge1100-002-181206162022-08-18
00840097504759restor3d Osteotomy Wedge1100-002-181207192022-08-18
00840097504766restor3d Osteotomy Wedge1100-002-181208222022-08-18
00840097504773restor3d Osteotomy Wedge1100-002-181210282022-08-18
00840097504780restor3d Osteotomy Wedge1100-002-181212342022-08-18
00840097503110restor3d Disposable Instrument, Wedge Trial6100-NSP-A04052021-11-15
00840097503127restor3d Disposable Instrument, Wedge Trial6100-NSP-A05062021-11-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
TKRL0001F1540PointCloud Knee InstrumentsUnik Orthopedics Inc.OOG2026-10-20
TKRL0001F1B80PointCloud Knee InstrumentsUnik Orthopedics Inc.OOG2026-10-20
TKRL0001F34K0PointCloud Knee InstrumentsUnik Orthopedics Inc.OOG2026-10-20
TKRL0001F6000PointCloud Knee InstrumentsUnik Orthopedics Inc.OOG2026-10-20
TKRL0001F7300PointCloud Knee InstrumentsUnik Orthopedics Inc.OOG2026-10-20
TKRL0001F7940PointCloud Knee InstrumentsUnik Orthopedics Inc.OOG2026-10-20
TKRL0001F7F80PointCloud Knee InstrumentsUnik Orthopedics Inc.OOG2026-10-20
TKRL0001F9F00PointCloud Knee InstrumentsUnik Orthopedics Inc.OOG2026-10-20
TKRL0001FF640PointCloud Knee InstrumentsUnik Orthopedics Inc.OOG2026-10-20
TKRL0001FLI00PointCloud Knee InstrumentsUnik Orthopedics Inc.OOG2026-10-20
TKRL0001KF5I0PointCloud Knee InstrumentsUnik Orthopedics Inc.OOG2026-10-20
TKRL0001L0LD0PointCloud Knee InstrumentsUnik Orthopedics Inc.OOG2026-10-20
TKRL0001L4120PointCloud Knee InstrumentsUnik Orthopedics Inc.OOG2026-10-20
TKRL0001L7FI0PointCloud Knee InstrumentsUnik Orthopedics Inc.OOG2026-10-20
TKRL0001L9260PointCloud Knee InstrumentsUnik Orthopedics Inc.OOG2026-10-20
TKRL000200F30PointCloud Knee InstrumentsUnik Orthopedics Inc.OOG2026-10-20
TKRL000201K20PointCloud Knee InstrumentsUnik Orthopedics Inc.OOG2026-10-20
TKRL000202L80PointCloud Knee InstrumentsUnik Orthopedics Inc.OOG2026-10-20
TKRL000203ID0PointCloud Knee InstrumentsUnik Orthopedics Inc.OOG2026-10-20
TKRL000205I00PointCloud Knee InstrumentsUnik Orthopedics Inc.OOG2026-10-20
TKRL0002066I0PointCloud Knee InstrumentsUnik Orthopedics Inc.OOG2026-10-20
TKRL000207330PointCloud Knee InstrumentsUnik Orthopedics Inc.OOG2026-10-20
TKRL000208K50PointCloud Knee InstrumentsUnik Orthopedics Inc.OOG2026-10-20
TKRL0002098I0PointCloud Knee InstrumentsUnik Orthopedics Inc.OOG2026-10-20
TKRL000209F30PointCloud Knee InstrumentsUnik Orthopedics Inc.OOG2026-10-20
TKRL00020D0F0PointCloud Knee InstrumentsUnik Orthopedics Inc.OOG2026-10-20
TKRL00020F080PointCloud Knee InstrumentsUnik Orthopedics Inc.OOG2026-10-20
TKRL00020F670PointCloud Knee InstrumentsUnik Orthopedics Inc.OOG2026-10-20
TKRL00020I510PointCloud Knee InstrumentsUnik Orthopedics Inc.OOG2026-10-20
TKRL00020IBI0PointCloud Knee InstrumentsUnik Orthopedics Inc.OOG2026-10-20