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510(k) Data Aggregation
K Number
K200123Device Name
Accessories for the SixFix® Hexapod Fixator
Manufacturer
Date Cleared
2020-09-22
(245 days)
Product Code
Regulation Number
888.3030Why did this record match?
Applicant Name (Manufacturer) :
Arrowhead DE, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The SixFix® Hexapod Fixator is intended to be used for post-traumatic joint contracture which has resulted in loss of range of motion; fractures and disease which generally may result in joint contractures or loss of range of motion and fractures requiring distraction; open and closed fracture fixation; pseudo-arthrosis of long bones; limb lengthening by epiphyseal or metaphyseal distraction of bony or soft tissue deformities; correction of bony or soft tissue defects; joint arthrodesis; infected fractures or nonunions.
Device Description
The SixFix Hexapod Fixator is a multilateral circular external fixation system. The system includes the following external fixator elements: rings, arches, struts, threaded rods, reduction struts, and assembly accessories. All the elements are provided non-sterile and are for single use only.
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K Number
K190069Device Name
SixFix Hexapod Fixator and Deformity Analysis and Correction Software (DACS)
Manufacturer
Date Cleared
2019-05-14
(119 days)
Regulation Number
888.3030Why did this record match?
Applicant Name (Manufacturer) :
Arrowhead DE, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The SixFix™ Hexapod and Deformity Analysis and Correction Software (DACS) are intended to be used for posttraumatic joint contracture which has resulted in loss of range of motion; fractures and disease which generally may result in joint contractures or loss of range of motion and fractures requiring distraction; open and closed fracture fixation; pseudo-arthrosis of long bones; limb lengthening by epiphyseal or metaphyseal distraction; correction of bony or soft tissue deformities; correction of bony or soft tissue defects; joint arthrodesis; infected fractures or nonunions.
Device Description
The SixFix™ Hexapod Fixator is a multilateral circular external fixation system. The system includes the following external fixator elements: rings, footplates, arches, struts, threaded rods, wires, external fixation accessories, and software. All of the elements are provided non-sterile and are for single use only.
The system is designed such that gradually adjusting the lengths of the struts in relation to one another alters the orientation of the rings and, consequently, the bone segments connected to the rings by half-pins and wires during the treatment period in order to achieve the patient's treatment goals.
The Deformity Analysis and Correction Software is an optional software component and is used to assist the physician in calculating the lengths of the struts connecting the rings to manipulate the bone fragments. The software receives inputs from the physician and allows the physician to visualize the moving bone position. The program computes the strut lengths necessary to implement any desired translation and/or rotation required by the surgeon.
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K Number
K162032Device Name
Arrowhead Mini-Rail Fixator
Manufacturer
Date Cleared
2017-02-21
(214 days)
Regulation Number
888.3030Why did this record match?
Applicant Name (Manufacturer) :
Arrowhead DE, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Arrowhead Mini-Rail Fixator is indicated for stabilizing various fractures including open and comminuted fractures, infected non-unions, fractures with length discrepancies, fusions and corrective osteotomies of the metarsal, ulnar, and calcaneal bones.
Device Description
The Arrowhead Mini-Rail Fixator is a unilateral fixator that provides a stable solution for fractures, for lengthening of bones and for correcting deformities.
The Fixation Clamps are capable of controlled linear translation along the rail and of applying either compression or distraction forces. Because the Fixation Clamps can move along the rail independently of one another, a distraction force can be applied at one location along the Fixation Rail and distraction forces applied at another location along the same Fixation Rail.
The Fixation Clamps are capable of securing Fixation Screws with a diameter of 1.6mm to 3.0mm. The rail system and clamps are manufactured from aluminum and stainless steel. The fixation screws are stainless steel and available with and without hydroxyapatite coating.
The fixation screws are provided sterile while the non-implantable fixator components are provided non-sterile.
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