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510(k) Data Aggregation
K Number
K160427Device Name
dynaMX(TM) Nitinol Compression Screw
Manufacturer
Date Cleared
2016-06-03
(108 days)
Product Code
Regulation Number
888.3040Why did this record match?
Applicant Name (Manufacturer) :
MX ORTHOPEDICS CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The dynaMX™ Nitinol Compression Screw is indicated for fixation of intra-articular and extra-articular fractures and non-unions of small bones and small bone fragments; arthrodesis of small joints; bunionectomies and osteotomies. Examples include, but are not limited to scaphoid and other carpal bones, metacarpals, tarsals, metatarsals, patella, ulnar styloid, capitellum, radial head and radial styloid. The implants are intended for single use only.
Device Description
The dynaMX™ Nitinol Compression Screw is a cannulated self-drilling / self-tapping screw with a threaded head which can be countersunk into the bone. The screw is available in a range of lengths from 16mm to 40mm in 2mm increments. The screw is manufactured from biocompatible superelastic Nitinol is fully transformed at room temperature and requires no external heating. Screws are shipped pre-elongated (i.e., stretched). An internal retaining pin maintains the screw in the stretched condition. Following implantation of the screw, removal of the internal retaining pin causes the screw to want shorten to its original un-stretched length. This action generates compression across the fracture site.
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