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ToeTac 10° Hammertoe Fixation System

by Restore Surgical, LLC Dba Instratek

510(k) K161778

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 25 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK161778 Date22 Nov 2016ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 25 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

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

Overview

AI-generated summary, 24 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The ToeTac 10° Hammertoe Fixation System is a bone fixation device used in orthopedic surgery for the fixation of osteotomies and reconstruction of the lesser toes following correction procedures for hammertoe, claw toe, and mallet toe. It consists of a threaded PEEK implant and associated surgical instruments for site preparation and delivery.

The device was cleared through the FDA 510(k) process under K161778, with a traditional clearance type and product code HWC. It is manufactured by Restore Surgical, LLC Dba Instratek located at 15200 Middlebrook Dr., Suite G, Houston, TX 77058.

Other devices from Restore Surgical, LLC Dba Instratek

Questions

AI-generated answers, 24 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the ToeTac 10° Hammertoe Fixation System used for?

    It is used in orthopedic surgery to fixate osteotomies and reconstruct the lesser toes after correction procedures for hammertoe, claw toe, and mallet toe, providing stable fixation of bone during healing.

  • What materials and components make up the ToeTac 10° Hammertoe Fixation System?

    The system consists of a threaded PEEK (polyetheretherketone) implant and associated surgical instruments designed for site preparation and delivery of the implant during toe reconstruction procedures.

  • How was the ToeTac 10° Hammertoe Fixation System cleared for market release?

    The device received FDA clearance through the 510(k) pathway under submission K161778, with a traditional clearance decision based on substantial equivalence to a predicate device.