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Great Toe Implant System

by Harmos Orthopaedics, Inc.

510(k) K014164

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK014164 Date12 Mar 2002ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 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  • Withdrawn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
KWD
Device Class
Class II
Regulation
21 CFR Part 888.3730
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 Great Toe Implant System is a prosthesis for the toe, specifically a hemi-phalangeal implant, classified as a Class II medical device under FDA regulation 888.3730. It is intended for use in the treatment of patients with inflammatory arthritis in the first metatarsal joint, particularly in cases with good bone stock and integrity of the first metatarsal head, and is indicated for conditions including hallux valgus, hallux rigidus, and an unstable or painful metatarsophalangeal (MTP) joint.

The device was cleared by the FDA through the traditional 510(k) pathway under K014164, with a decision date of March 12, 2002, and is substantially equivalent to predicate devices. It is manufactured by Harmos Orthopaedics, Inc., and is supplied as a single-use implant system for orthopedic surgical procedures, with no indication of reusability or MRI safety provided in the data.

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 Great Toe Implant System used for?

    The Great Toe Implant System is a hemi-phalangeal prosthesis intended for treating patients with inflammatory arthritis in the first metatarsal joint, particularly when there is good bone stock and integrity of the first metatarsal head, and is indicated for conditions including hallux valgus, hallux rigidus, and an unstable or painful metatarsophalangeal (MTP) joint.

  • How is the Great Toe Implant System supplied and is it reusable?

    The device is supplied as a single-use implant system for orthopedic surgical procedures, with no indication of reusability provided in the data, meaning it is intended for one-time use only and should not be reprocessed or reused.

  • What regulatory pathway was used for the Great Toe Implant System?

    The Great Toe Implant System was cleared by the FDA through the traditional 510(k) pathway under K014164, with a decision date of March 12, 2002, and is substantially equivalent to predicate devices.