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Pro-Toe(Tm) Vo Hamertoe Implant System-Line Sddition

by Wrightmedicaltechnologyinc 510(k)

Active United States

510(k) K120645

Overview

The Pro-Toe Vo Hammertoe Implant System is an orthopedic bone fixation device used for the reconstruction of lesser toes. It is designed to stabilize bone in surgical procedures involving the lesser toes.

This line addition introduces an extended range of sizes and an additional material option (titanium alloy) to the previously cleared stainless steel implants. The device is intended for use by surgeons in a clinical or surgical setting and is supplied as a sterile, single-use implant. It has received FDA 510(k) clearance under product code HWC, classified as a Class II device with special controls.

AI-generated from registry data, 24 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK120645 Date24 Apr 2012ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
HWC
Device Class
Class II
Regulation
21 CFR Part 888.3040
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

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Questions

  • What is the Pro-Toe Vo Hammertoe Implant System used for?

    The Pro-Toe Vo Hammertoe Implant System is an orthopedic bone fixation device used to stabilize bone during surgical reconstruction of lesser toes, providing structural support in procedures involving the lesser toes.

  • How is the Pro-Toe Vo Hammertoe Implant System supplied and is it reusable?

    The device is supplied as a sterile, single-use implant, meaning each unit is intended for one surgical procedure only and must be discarded after use to maintain sterility and prevent cross-contamination.

  • What sizes and material options are available in this line addition of the Pro-Toe Vo Hammertoe Implant System?

    This line addition introduces an extended range of sizes and an additional material option—titanium alloy—to the previously cleared stainless steel implants, offering surgeons greater flexibility in implant selection based on patient anatomy and surgical needs.