iTotal Identity 3DP Porous Knee

GUDID 00840097515205

iTotal Identity CR 3DP Porous Femur Hybrid iJigs Right

Restor3d, Inc.

Total knee prosthesis implantation guide-instrument kit

• Primary Device ID: 00840097515205
• NIH Device Record Key: 37eed05d-da0b-4829-ae93-c118c02be5bf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: iTotal Identity 3DP Porous Knee
• Version Model Number: TCR-000-SPEC-020131
• Company DUNS: 080819836
• Company Name: Restor3d, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840097515205 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K243768

FDA Product Code

• OOG: Knee Arthroplasty Implantation System

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-12-10
• Device Publish Date: 2025-12-02

On-Brand Devices [iTotal Identity 3DP Porous Knee]

• 00840097515205: iTotal Identity CR 3DP Porous Femur Hybrid iJigs Right
• 00840097515199: iTotal Identity CR 3DP Porous Femur Hybrid iJigs Left
• 00840097515182: iTotal Identity CR 3DP Porous Tibia Hybrid iJigs Right
• 00840097515175: iTotal Identity CR 3DP Porous Tibia Hybrid iJigs Left
• 00840097515168: iTotal Identity CR 3DP Porous iJigs Right
• 00840097515151: iTotal Identity CR 3DP Porous iJigs Left
• 00840097515144: iTotal Identity 3DP Porous Round Patella 44mm x 12mm
• 00840097515137: iTotal Identity 3DP Porous Round Patella 41mm x 11mm
• 00840097515120: iTotal Identity 3DP Porous Round Patella 38mm x 10mm
• 00840097515113: iTotal Identity 3DP Porous Round Patella 35mm x 10mm
• 00840097515106: iTotal Identity 3DP Porous Round Patella 32mm x 9mm
• 00840097515090: iTotal Identity CR 3DP Porous Tibial Tray Right
• 00840097515083: iTotal Identity CR 3DP Porous Tibial Tray Left
• 00840097515076: iTotal Identity CR 3DP Porous Femoral Implant Right
• 00840097515069: iTotal Identity CR 3DP Porous Femoral Implant Left