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Montross Extremity Medical Hemi Implant System

by Montross Extremity Medical

510(k) K221220

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 NumberK221220 Date19 Apr 2023ClearedStatusActive

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  • Withdrawn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, 21 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 Montross Extremity Medical Hemi Implant System is a prosthesis designed for resurfacing the 1st metatarsal head or the base of the proximal phalanx, consisting of a metatarsal component and a phalangeal component. It is classified as a device of type Prosthesis, Toe, Hemi-, Phalangeal. The system is used in orthopedic applications.

The Montross Extremity Medical Hemi Implant System is supplied with FDA 510K authorizations and is classified as a class 2 device. It has a regulation number of 888.3730 and a product code of KWD. The device is designed for use in orthopedic settings and has been reviewed by the Orthopedic advisory committee.

Questions

AI-generated answers, 21 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 Montross Hemi Implant System used for?

    The Montross Hemi Implant System is used for resurfacing the 1st metatarsal head or the base of the proximal phalanx in orthopedic applications, consisting of a metatarsal component and a phalangeal component.

  • What type of device is the Montross Hemi Implant System?

    The Montross Hemi Implant System is classified as a Prosthesis, Toe, Hemi-, Phalangeal, which is a class 2 device.

  • What authorizations does the Montross Hemi Implant System have?

    The Montross Hemi Implant System has FDA 510K authorizations.

  • What is the regulation number for the Montross Hemi Implant System?

    The regulation number for the Montross Hemi Implant System is 888.3730.