Kinos Total Ankle Replacements

GUDID 00840097510774

Range Bearing Implant, Size 3, Left, 8mm

Restor3d, Inc.

Ankle prosthesis bearing

• Primary Device ID: 00840097510774
• NIH Device Record Key: 18f15788-ba69-4cca-b6ab-a2f0aacc3193
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Kinos Total Ankle Replacements
• Version Model Number: 3832-1308
• Company DUNS: 080819836
• Company Name: Restor3d, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• 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	00840097510774 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K240591

FDA Product Code

• HSN: Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer

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: 2024-07-03
• Device Publish Date: 2024-06-25

Devices Manufactured by Restor3d, Inc.

• 00840097515069 - iTotal Identity 3DP Porous Knee: 2025-12-10 iTotal Identity CR 3DP Porous Femoral Implant Left
• 00840097515076 - iTotal Identity 3DP Porous Knee: 2025-12-10 iTotal Identity CR 3DP Porous Femoral Implant Right
• 00840097515083 - iTotal Identity 3DP Porous Knee: 2025-12-10 iTotal Identity CR 3DP Porous Tibial Tray Left
• 00840097515090 - iTotal Identity 3DP Porous Knee: 2025-12-10 iTotal Identity CR 3DP Porous Tibial Tray Right
• 00840097515106 - iTotal Identity 3DP Porous Knee: 2025-12-10 iTotal Identity 3DP Porous Round Patella 32mm x 9mm
• 00840097515113 - iTotal Identity 3DP Porous Knee: 2025-12-10 iTotal Identity 3DP Porous Round Patella 35mm x 10mm
• 00840097515120 - iTotal Identity 3DP Porous Knee: 2025-12-10 iTotal Identity 3DP Porous Round Patella 38mm x 10mm
• 00840097515137 - iTotal Identity 3DP Porous Knee: 2025-12-10 iTotal Identity 3DP Porous Round Patella 41mm x 11mm