FDA.report

Kinos Aeros Total Ankle Replacement

Primary DI
00840097516219
Brand
Kinos Aeros Total Ankle Replacement
Company
Restor3d, Inc.
Model
1832-0051
Device description
Modular Stem Tibial Implant, Size 5, Long with Tidal Technology
Published
2025-05-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
HSNProsthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer

Product Code Classifications

CodeDeviceSpecialtyClass
HSNProsthesis, Ankle, Semi-Constrained, Cemented, Metal/PolymerOrthopedic2

Premarket Submissions

SubmissionSupplement
K242868000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K242868000Kinos Total Ankle SystemRestor3D2024-10-18HSN

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00840097516219PrimaryGS10

GMDN Terms

TermDefinition
Coated ankle tibia prosthesisA sterile implantable device designed to replace the distal tibia (tibial component) as part of a primary ankle joint replacement or prosthesis revision. The device is made of metal [e.g., titanium (Ti), cobalt-chrome (Co-Cr), stainless steel] and is coated with a material (e.g., porous materials, hydroxyapatite) intended to improve fixation and stability by promoting bone ingrowth. Fixation devices for implantation (e.g., screws) may be included and implantation may be performed with or without bone cement.

Sterilization Methods

Method

Regulatory Flags

DUNS number
080819836
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
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

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00840097519364Ossera™ AFX1740-36422025-12-18
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00840097532387Ossera™ AFX Instrumentation5740-36362025-12-18
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10885862656933VantageExactech, Inc.HSN2026-03-10
10885862656940VantageExactech, Inc.HSN2026-03-10
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