FDA.reportPublic FDA data

LINK™ External Fixator

Primary DI
M96320TG0
Brand
LINK™ External Fixator
Company
METRIC MEDICAL DEVICES, INC.
Model
20TG
Catalog number
20TG
Device description
2.0 mm Diameter, Threaded and Grooved Bone Pins as part of the LINK™ External Fixator, provided in a segregate package to allow for control of the amount of pins used per procedure.The LINK™ External Fixator is indicated for use in the treatment of bone conditions including osteotomy, arthrodesis, fracture fixation and other bone conditions amenable to treatment by use of the external fixation modality. The LINK™ External Fixation System components are not intended to replace normal healthy bone or to withstand the stresses of full weightbearing, particularly in unstable fractures or in the presence of non-union, delayed union or incomplete healing. The use of external supports (e.g. walking aids) is recommended as a part of the treatment.
Published
2024-06-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
KTTAppliance, Fixation, Nail/Blade/Plate Combination, Multiple Component

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KTTAppliance, Fixation, Nail/Blade/Plate Combination, Multiple ComponentOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K240049000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K240049000LINK(TM) External FixatorMetric Medical Devices, Inc.2024-05-29KTT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M96320TG0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
External orthopaedic fixation system, single-useAn assembly of devices designed to stabilize fractured bones to promote treatment and healing. It typically consists of an external plastic and/or metallic fixator (a framework) and other external and/or implantable components such as clamps, rods, rings, pins, bolts, and nuts, as well as some reusable instrumentation (e.g., wrenches, depth gauge, tensioner). It is used mainly to help the healing of long bones such as the femur, tibia and humerus, as well as fractures of the foot and ankle, joint fusions, and limb lengthening. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Length6Inch
Outer Diameter2Millimeter

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
830255506
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M9632265L30SuperScaffold™2265L32265L32018-04-25
M9632565L30Intramedullary Fixation Scaffold (IFS)2565L32565L32016-12-13
M9632565S30Intramedullary Fixation Scaffold (IFS)2565S32565S32016-09-26
M9632585L30Intramedullary Fixation Scaffold (IFS)2585L32585L32016-12-13
M9632585S20Intramedullary Fixation Scaffold (IFS)2585S22585S22016-09-26
M9632585S30Intramedullary Fixation Scaffold (IFS)2585S32585S32016-12-13
M963IFS250Intramedullary Fixation Scaffold (IFS)IFS2.5IFS2.52016-09-26
M96316TT0LINK™ External Fixator16TT16TT2024-06-07
M96320TT0LINK™ External Fixator20TT20TT2024-06-07
M96322000200LINK™ External Fixator2-2000202-2000202024-06-07
M9634H201020LINK™ External Fixator4H2010204H2010202024-06-07
M963C200LINK™ External FixatorC-20C-202024-06-07
M963CH20100LINK™ External FixatorCH2010CH20102024-06-07
M963174010Super Staple™ Classic17401174012016-09-26
M963200630SuperSTEP™20063200632018-09-07
M963200830SuperSTEP™20083200832018-09-07
M963201030SuperSTEP™20103201032018-09-07
M963166010Super Staple™ Classic16601166012017-10-31
M963168010Super Staple™ Classic16801168012016-09-26
M963169010Super Staple™ Classic16901169012016-09-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08903993241486130° Wise-Lock DHS Plate, 2 Holes, Stainless SteelAuxein Medical Private LimitedKTT2026-04-18
08903993241493130° Wise-Lock DHS Plate, 3 Holes, Stainless SteelAuxein Medical Private LimitedKTT2026-04-18
08032909626380ST.A.R. 90 F4CITIEFFE SRLKTT2026-03-17
08051739535730ST.A.R. 90 F4CITIEFFE SRLKTT2026-03-10
08059386747391DOLPHIXCITIEFFE SRLKTT2025-04-02
10080196692729MEDLINEMEDLINE INDUSTRIES, INC.KTT2025-01-29
10080196692866MEDLINEMEDLINE INDUSTRIES, INC.KTT2025-01-29
10080196692910MEDLINEMEDLINE INDUSTRIES, INC.KTT2025-01-29
10080196692927MEDLINEMEDLINE INDUSTRIES, INC.KTT2025-01-29
10080196692941MEDLINEMEDLINE INDUSTRIES, INC.KTT2025-01-29
10080196692965MEDLINEMEDLINE INDUSTRIES, INC.KTT2025-01-29
10193489002065MEDLINEMEDLINE INDUSTRIES, INC.KTT2025-01-29
08032909624263ST.A.R. 90 F4CITIEFFE SRLKTT2024-09-11
08032909624270ST.A.R. 90 F4CITIEFFE SRLKTT2024-09-11
08032909624317ST.A.R. 90 F4CITIEFFE SRLKTT2024-07-19
08032909624355ST.A.R. 90 F4CITIEFFE SRLKTT2024-07-19
08032909624362ST.A.R. 90 F4CITIEFFE SRLKTT2024-07-19
08032909627639DOLPHIXCITIEFFE SRLKTT2020-01-10
08052990974535DOLPHIXCITIEFFE SRLKTT2020-01-10
08051739536225ST.A.R. 90 F4CITIEFFE SRLKTT2019-11-29
08051739531244DOLPHIXCITIEFFE SRLKTT2019-05-18
08052990972661DOLPHIXCITIEFFE SRLKTT2019-05-18
08052990974542DOLPHIXCITIEFFE SRLKTT2019-05-18
08052990974566DOLPHIXCITIEFFE SRLKTT2019-05-18
08051739531725DOLPHIXCITIEFFE SRLKTT2019-01-09
08051739531732DOLPHIXCITIEFFE SRLKTT2019-01-09
08051739531749DOLPHIXCITIEFFE SRLKTT2019-01-09
08051739531756DOLPHIXCITIEFFE SRLKTT2018-12-15
08051739531763DOLPHIXCITIEFFE SRLKTT2018-12-15
08051739531770DOLPHIXCITIEFFE SRLKTT2018-12-15