FDA.report

Kinos Aeros Total Ankle Replacement

Primary DI
00840097532363
Brand
Kinos Aeros Total Ankle Replacement
Company
Restor3d, Inc.
Model
1843-1000
Device description
Aeros Locking Screw
Published
2025-08-13
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
00840097532363PrimaryGS10

GMDN Terms

TermDefinition
Fixed-bearing total ankle prosthesisA sterile implantable artificial substitute for an ankle joint designed to replace the main articulating surfaces of the damaged (e.g., fractured) and/or degenerative (e.g., arthritic) joint. It includes tibial and talar components typically with parts made of metal and polyethylene (PE); the PE bearing that articulates the two components is attached or moulded to one of the components. Fixation devices (e.g., screws) for implantation 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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00840097515731Ossera™ AFX Instrumentation5740-34402025-12-18
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00840097519340Ossera™ AFX1740-34362025-12-18
00840097519357Ossera™ AFX1740-36322025-12-18
00840097519364Ossera™ AFX1740-36422025-12-18
00840097519371Ossera™ AFX1740-40362025-12-18
00840097519388Ossera™ AFX1740-40462025-12-18
00840097532370Ossera™ AFX Instrumentation5740-36322025-12-18
00840097532387Ossera™ AFX Instrumentation5740-36362025-12-18
00840097533599Ossera™ AFX Instrumentation5741-24012025-12-18
00840097533612Ossera™ AFX Instrumentation5741-34012025-12-18
00840097533629Ossera™ AFX Instrumentation5741-36012025-12-18

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10885862656865VantageExactech, Inc.HSN2026-03-10
10885862656872VantageExactech, Inc.HSN2026-03-10
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10885862656902VantageExactech, Inc.HSN2026-03-10
10885862656919VantageExactech, Inc.HSN2026-03-10
10885862656926VantageExactech, Inc.HSN2026-03-10
10885862656933VantageExactech, Inc.HSN2026-03-10
10885862656940VantageExactech, Inc.HSN2026-03-10
00889795154026APEX 3D Total Ankle Replacement SystemParagon 28, Inc.HSN2026-02-19
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00840097533698Kinos Total Ankle InstrumentationRestor3d, Inc.HSN2025-12-12
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