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
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
00840097532363PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840097532363008400975323638400975323630840097532363

GMDN Terms#

Term, Definition table
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 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
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
00840097536668Veritas rTSA Instrumentation5500-32022026-06-25
00840097535678Veritas rTSA3500-142U12026-06-03
00840097535692Veritas rTSA3500-142C12026-06-03
00840097535715Veritas rTSA3500-142U32026-06-03
00840097535739Veritas rTSA3500-142C32026-06-03
00840097535753Veritas rTSA3500-342U12026-06-03
00840097535777Veritas rTSA3500-342C12026-06-03
00840097535791Veritas rTSA3500-342U32026-06-03
00840097535814Veritas rTSA3500-342C32026-06-03
00840097535838Veritas rTSA3500-542U12026-06-03
00840097535852Veritas rTSA3500-542C12026-06-03

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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
B095322216Hintermann Series H2Dt Medtech, LLCHSN2018-03-19
10381780237730Cadence™Ascension Orthopedics, Inc.HSN2016-01-12
10381780237747Cadence™Ascension Orthopedics, Inc.HSN2016-01-12
10381780237754Cadence™Ascension Orthopedics, Inc.HSN2016-01-12
10381780237761Cadence™Ascension Orthopedics, Inc.HSN2016-01-12
10381780237778Cadence™Ascension Orthopedics, Inc.HSN2016-01-12
10381780237785Cadence™Ascension Orthopedics, Inc.HSN2016-01-12
10381780237792Cadence™Ascension Orthopedics, Inc.HSN2016-01-12
10381780237808Cadence™Ascension Orthopedics, Inc.HSN2016-01-12
10381780237815Cadence™Ascension Orthopedics, Inc.HSN2016-01-12
10381780237822Cadence™Ascension Orthopedics, Inc.HSN2016-01-12
10381780237839Cadence™Ascension Orthopedics, Inc.HSN2016-01-12
10381780237846Cadence™Ascension Orthopedics, Inc.HSN2016-01-12
10381780237853Cadence™Ascension Orthopedics, Inc.HSN2016-01-12
10381780237860Cadence™Ascension Orthopedics, Inc.HSN2016-01-12
10381780237877Cadence™Ascension Orthopedics, Inc.HSN2016-01-12
10381780237884Cadence™Ascension Orthopedics, Inc.HSN2016-01-12
10381780237891Cadence™Ascension Orthopedics, Inc.HSN2016-01-12
10381780237907Cadence™Ascension Orthopedics, Inc.HSN2016-01-12
10381780237914Cadence™Ascension Orthopedics, Inc.HSN2016-01-12
10381780237921Cadence™Ascension Orthopedics, Inc.HSN2016-01-12
10381780237938Cadence™Ascension Orthopedics, Inc.HSN2016-01-12
10381780237945Cadence™Ascension Orthopedics, Inc.HSN2016-01-12