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510(k) Data Aggregation
K Number
K140649Device Name
VECTRIX EXTERNAL FIXATOR
Manufacturer
Date Cleared
2014-12-29
(291 days)
Regulation Number
888.3040Why did this record match?
Applicant Name (Manufacturer) :
3D MEDICAL CONCEPTS, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Vectrix External Fixator is indicated for use in which external fixation is necessary for the treatment of long- and shortbone trauma and reconstruction in adult and pediatic patients, including limb lengthening, pseudarthroses, infected fractures, distraction, arthrodesis, and severe open fractures.
Device Description
The Vectrix External Fixator is a comprehensive and modular external fixator, the design of which is based on a ball collet pin clamp system and consists of:
- 6AL-4V titanium and/or 304SS stainless steel spline . rod (0.125, 0.25, and 0.375 inches in diameter)
- . 6AL-4V titanium and/or 316L stainless steel selftapping, threaded fixation pins (5.0 mm and 4.0 mm thread diameter pins with thread lengths from 25 mm to 75 mm, varying in 5 mm increments; and 3.5 mm thread diameter pins with thread lengths of 15 mm)
- Titanium pin clamps
- Titanium ball collets ●
- Titanium collet caps
- Titanium drive knob ●
- Titanium drive screw ●
Fixation pins are percutaneously inserted into the bone segments and secured with pin clamps to the external spline rod. The choice of thread diameter and length is made by the surgeon on a case-by-case basis. The ball and collet design allows extensive pin rotation and, thus, pin placement freedom.
The system can be assembled in three sizes, determined by the spline rod size. Furthermore, elements of the system may be combined in a wide range of configurations as needed to achieve the external fixation structure best suited for each patient. The drive screw and drive knob can also be added to the spline rod constructs of each size to mediate bone compression and distraction for limb reconstruction.
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