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510(k) Data Aggregation
K Number
K172205Device Name
ExoToe Staple
Manufacturer
Date Cleared
2018-01-11
(174 days)
Product Code
Regulation Number
888.3030Why did this record match?
Applicant Name (Manufacturer) :
ExoToe LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
ExoToe Staple is intended for fracture and osteotomy fixation and joint arthrodesis of the foot in conjunction with k-wire fixation.
Device Description
The ExoToe Staple is an implant that is crimped onto bone with forceps after a k-wire has been placed to achieve fixation. The ExoToe Staple is provided in a sterile package. A kit containing four sizing templates and forceps is provided non-sterile. The staple is comprised of stainless steel and is pre-formed during manufacturing. The sizing templates and pliers are comprised of stainless steel. The sizing templates are used to select staple size. The forceps are used by a surgeon to conduct the final deformation required to anchor the staple to the bone.
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