FDA.reportPublic FDA data

Kinos Total Ankle Instrumentation

Primary DI
00840097517742
Brand
Kinos Total Ankle Instrumentation
Company
Restor3d, Inc.
Model
5801-4074
Device description
Short X-Blade, Right, Stryker Hub
Published
2025-06-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
K232595000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K232595000Kinos Axiom Total Ankle SystemRestor3D2023-11-28HSN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840097517742PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840097517742008400975177428400975177420840097517742

GMDN Terms#

Term, Definition table
TermDefinition
Surgical saw blade, reciprocating, reusableA flat surgical cutting instrument, usually made of high-grade stainless steel, with a serrated edge designed for attachment to a dedicated powered saw used for cutting bone/tissue during orthopaedic or oral surgery; it is not dedicated to cutting through the sternum (i.e., not a dedicated sternum saw blade). This device is designed with the cutting teeth arranged in a straight line along the cutting edge and which cuts when the blade is powered in a rapid reciprocating movement (a back and forth motion like a jigsaw) against the object to be cut. The end of the blade is typically not protected. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
080819836
Device count
1
Lot or batch
true
Sterilization required before use
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
B095322305Hintermann Series H2Dt Medtech, LLCHSN2018-03-20
B095322306Hintermann Series H2Dt Medtech, LLCHSN2018-03-20
B095322307Hintermann Series H2Dt Medtech, LLCHSN2018-03-20
B095322315Hintermann Series H2Dt Medtech, LLCHSN2018-03-20
B095322316Hintermann Series H2Dt Medtech, LLCHSN2018-03-20
B095322317Hintermann Series H2Dt Medtech, LLCHSN2018-03-20
B095322325Hintermann Series H2Dt Medtech, LLCHSN2018-03-20
B095322326Hintermann Series H2Dt Medtech, LLCHSN2018-03-20
B095322327Hintermann Series H2Dt Medtech, LLCHSN2018-03-20
B095322329Hintermann Series H2Dt Medtech, LLCHSN2018-03-20
B095322129Hintermann Series H2Dt Medtech, LLCHSN2018-03-19
B095322215Hintermann Series H2Dt Medtech, LLCHSN2018-03-19
B095322216Hintermann Series H2Dt Medtech, LLCHSN2018-03-19
B095322217Hintermann Series H2Dt Medtech, LLCHSN2018-03-19
B095322219Hintermann Series H2Dt Medtech, LLCHSN2018-03-19
B095322226Hintermann Series H2Dt Medtech, LLCHSN2018-03-19
10381780237730Cadence™Ascension Orthopedics, Inc.HSN2016-01-12