Kinos Aeros Total Ankle Replacement

GUDID 00840097516196

Modular Stem Tibial Implant, Size 4, Long with Tidal Technology

Restor3d, Inc.

Coated ankle tibia prosthesis

• Primary Device ID: 00840097516196
• NIH Device Record Key: b3c0cc1b-0deb-4ac0-8733-e6f4d0e7ad5d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Kinos Aeros Total Ankle Replacement
• Version Model Number: 1832-0041
• 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: 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	00840097516196 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K242868

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: 2025-05-09
• Device Publish Date: 2025-05-01

On-Brand Devices [Kinos Aeros Total Ankle Replacement]

• 00840097516271: Kinos Middle Modular Stem Segment, 18mm, with Locking Screw
• 00840097516264: Kinos Middle Modular Stem Segment, 16mm, with Locking Screw
• 00840097516257: Kinos Middle Modular Stem Segment,14mm, with Locking Screw
• 00840097516240: Kinos Proximal Modular Stem Segment, 16mm, with Locking Screw
• 00840097516233: Kinos Proximal Modular Stem Segment, 14mm, with Locking Screw
• 00840097516226: Modular Stem Tibial Implant, Size 5, Extra Long with Tidal Technology
• 00840097516219: Modular Stem Tibial Implant, Size 5, Long with Tidal Technology
• 00840097516202: Modular Stem Tibial Implant, Size 5, with Tidal Technology
• 00840097516196: Modular Stem Tibial Implant, Size 4, Long with Tidal Technology
• 00840097516189: Modular Stem Tibial Implant, Size 4, with Tidal Technology
• 00840097516172: Modular Stem Tibial Implant, Size 3, Long with Tidal Technology
• 00840097516165: Modular Stem Tibial Implant, Size 3, with Tidal Technology
• 00840097516158: Modular Stem Tibial Implant, Size 2, with Tidal Technology
• 00840097516141: Modular Stem Tibial Implant, Size 1, with Tidal Technology
• 00840097514949: Mod Stem Tibial Impactor
• 00840097514932: Stem Inserter
• 00840097514925: Flexible Reamer Guide
• 00840097532363: Aeros Locking Screw