Kinos Aeros Total Ankle Replacement

Primary DI
00840097516196
Brand
Kinos Aeros Total Ankle Replacement
Company
Restor3d, Inc.
Model
1832-0041
Device description
Modular Stem Tibial Implant, Size 4, 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
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
HSNProsthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HSNProsthesis, Ankle, Semi-Constrained, Cemented, Metal/PolymerOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K242868000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K242868000Kinos Total Ankle SystemRestor3D2024-10-18HSN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840097516196PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840097516196008400975161968400975161960840097516196

GMDN Terms#

Term, Definition table
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 table
Method

Regulatory Flags#

DUNS number
080819836
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840097534237Kinos Aeros Total Ankle Replacement1844-01022026-07-31
00840097534244Kinos Aeros Total Ankle Replacement1844-01042026-07-31
00840097534251Kinos Aeros Total Ankle Replacement1844-01062026-07-31
00840097534268Kinos Aeros Total Ankle Replacement1844-02042026-07-31
00840097534275Kinos Aeros Total Ankle Replacement1844-02062026-07-31
00840097534282Kinos Aeros Total Ankle Replacement1844-02082026-07-31
00840097536552iTotal Identity CR 3DP Porous5200-39322026-07-31
00840097536569iTotal Identity CR 3DP Porous5200-39352026-07-31
00840097536576iTotal Identity CR 3DP Porous5200-39382026-07-31
00840097536583iTotal Identity CR 3DP Porous5200-39412026-07-31
00840097536590iTotal Identity CR 3DP Porous5200-39442026-07-31
00840097513119Veritas Reverse Total Shoulder6500-90012026-07-24
00840097513126Veritas Reverse Total Shoulder6500-90022026-07-24
00840097513133Veritas Reverse Total Shoulder6500-90032026-07-24
00840097516004Veritas Reverse Total Shoulder1500-9001-P012026-07-24
00840097516011Veritas Reverse Total Shoulder1500-9001-P022026-07-24
00840097534206Velora Acetabular System Instrumentation5900-00052026-07-23
00840097534923Veritas Instrumentation6203-10022026-07-23
00840097534930Veritas Instrumentation6500-20602026-07-23
00840097536699Kinos Aeros Instrumentation5801-10002026-07-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840097534237Kinos Aeros Total Ankle ReplacementRestor3d, Inc.HSN2026-07-31
00840097534244Kinos Aeros Total Ankle ReplacementRestor3d, Inc.HSN2026-07-31
00840097534251Kinos Aeros Total Ankle ReplacementRestor3d, Inc.HSN2026-07-31
00840097534268Kinos Aeros Total Ankle ReplacementRestor3d, Inc.HSN2026-07-31
00840097534275Kinos Aeros Total Ankle ReplacementRestor3d, Inc.HSN2026-07-31
00840097534282Kinos Aeros Total Ankle ReplacementRestor3d, Inc.HSN2026-07-31
00889797111089PROPHECY INCOMPASSWRIGHT MEDICAL TECHNOLOGY, INC.HSN2026-06-23
00889797111096PROPHECY INCOMPASSWRIGHT MEDICAL TECHNOLOGY, INC.HSN2026-06-23
00889797111102PROPHECY INCOMPASSWRIGHT MEDICAL TECHNOLOGY, INC.HSN2026-06-23
00889797111119PROPHECY INCOMPASSWRIGHT MEDICAL TECHNOLOGY, INC.HSN2026-06-23
00889797111126PROPHECY INCOMPASSWRIGHT MEDICAL TECHNOLOGY, INC.HSN2026-06-23
00889797114820PROPHECY INCOMPASSWRIGHT MEDICAL TECHNOLOGY, INC.HSN2026-06-23
00889797114837PROPHECY INCOMPASSWRIGHT MEDICAL TECHNOLOGY, INC.HSN2026-06-23
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