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510(k) Data Aggregation
K Number
K200361Device Name
Akros Scruture Anchor LisFranc Repair Kit
Manufacturer
Akros Medical
Date Cleared
2020-04-06
(52 days)
Product Code
HTN
Regulation Number
888.3030Why did this record match?
Applicant Name (Manufacturer) :
Akros Medical
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Akros Scruture Anchor LisFranc Repair Kit is intended as an adjunct in fracture repair involving metaphyseal and periarticular small bone fragments where screws are not indicated, and as an adjunct in external fixation systems involving plates, with fracture braces and casting. Specifically, the Akros Scruture Anchor LisFranc Repair Kit is intended to provide fixation during the healing process following Tarasometatarsal (TMT) injury, such as fixation of foot soft tissue separations due to a Lisfranc injury (Midfoot Reconstruction).
Device Description
The Akros Scruture Anchor Lisfranc Repair Kit is a multiple-anchor orthopedic fixation device system, offered in both a stainless steel and a titanium version. The system is designed as an adjunct in repair of unstable joints, specifically as a means to provide fixation between the bones of the midfoot during the healing process following a Lisfranc injury. The design of the implant permits placement through any fracture repair plate that can accept a 4.0mm cortical screw conforming to ASTM F543-13. The anchors are provided pre-threaded and pre-loaded on their installation tools in a one-time-use pre-sterilized kit, with the Kirschner wire and drill bit needed for site preparation included.
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K Number
K173550Device Name
Akros FibuLink Syndesmosis Repair Kit
Manufacturer
Akros Medical
Date Cleared
2017-12-14
(28 days)
Product Code
HTN
Regulation Number
888.3030Why did this record match?
Applicant Name (Manufacturer) :
Akros Medical
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Akros FibuLink™ Syndesmosis Repair Kit is intended as an adjunct in fracture repair involving metaphyseal and periarticular small bone fragments where screws are not indicated and as an adjunct to fixation systems involving plates, with fracture braces and casting. Specifically, the Akros FibuLink™ Syndesmosis Repair Kit is intended to provide fixation during the healing process following a syndesmotic trauma, such as fixation of syndesmosis (syndesmosis disruptions) in connection with Weber B and C ankle fractures.
Device Description
The Akros FibuLink™ Syndesmosis Repair Kit is a multiple-anchor orthopedic fixation device system, offered in both a stainless steel and a titanium version. The system is designed as an adjunct in repair of unstable joints, specifically as a means to provide fixation between the tibia and fibula during the healing process following a disruption of the ankle syndesmosis. If a fracture of the fibula is present, the design of the fibula anchor permits placement through any fibula fracture repair plate that can accept a 3.5mm cortical screw conforming to ASTM F543-13. The anchors are provided pre-threaded and pre-loaded on their installation tools in a one-time-use pre-sterilized kit, with the Kirschner wire and drill bit needed for site preparation included.
The current submission is for minor design modifications to the components that make up the tibia and fibula anchors and corresponding changes to some of the tools used to install them.
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K Number
K162805Device Name
Akros Fibulink Syndesmosis Repair Kit
Manufacturer
Akros Medical
Date Cleared
2017-01-10
(97 days)
Product Code
HTN
Regulation Number
888.3030Why did this record match?
Applicant Name (Manufacturer) :
Akros Medical
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Akros FibuLink™ Syndesmosis Repair Kit is intended as an adjunct in fracture repair involving metaphyseal and periarticular small bone fragments where screws are not indicated and as an adjunct to fixation systems involving plates, with fracture braces and casting. Specifically, the Akros FibuLink™ Syndesmosis Repair Kit is intended to provide fixation during the healing process following a syndesmotic trauma, such as fixation of syndesmosis (syndesmosis disruptions) in connection with Weber B and C ankle fractures.
Device Description
The Akros FibuLink™ Syndesmosis Repair Kit is a multiple-anchor orthopedic fixation device system, offered in both a stainless steel and a titanium version. The system is designed as an adjunct in repair of unstable joints, specifically as a means to provide fixation between the tibia and fibula during the healing process following a disruption of the ankle syndesmosis. If a fracture of the fibula is present, the design of the fibula anchor permits placement through any fibula fracture repair plate that can accept a 3.5mm cortical screw conforming to ASTM F543-13. The anchors are provided pre-threaded and pre-loaded on their installation tools in a one-time-use pre-sterilized kit, with the Kirschner wire and drill bit needed for site preparation included.
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