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Metasurg Subtalar Implant

by Metasurg 2 variants

510(k) K070441

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 NumberK070441 Date8 May 2007ClearedStatusActive

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  • Withdrawn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
HWC
Device Class
Class II
Regulation
21 CFR Part 888.3040
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 6 Oct 2026

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

The Metasurg Subtalar Implant is a one-piece titanium device implanted into the sinus tarsi of the foot. It functions as a mechanical block to prevent excessive talar displacement, thereby stabilizing the subtalar joint while permitting normal motion.

It is used by surgeons for stabilization of the subtalar joint in patients with flatfoot deformities or instability. The device is supplied as a sterile, single-use implant and is classified under product code HWC as a bone fixation screw. It received FDA 510(k) clearance (K070441) and is subject to special controls for Class II devices.

Other devices from Metasurg

Questions

AI-generated answers, 6 Oct 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 Metasurg Subtalar Implant used for?

    It is used by surgeons to stabilize the subtalar joint in patients with flatfoot deformities or instability by acting as a mechanical block to prevent excessive talar displacement while allowing normal joint motion.

  • How is the Metasurg Subtalar Implant supplied and is it reusable?

    The device is supplied as a sterile, single-use implant, meaning it is intended for one-time use only and must not be resterilized or reused due to risks of contamination and material degradation.

  • What material is the Metasurg Subtalar Implant made of and what is its regulatory classification?

    It is a one-piece titanium device classified under product code HWC as a bone fixation screw and received FDA 510(k) clearance (K070441) as a Class II device subject to special controls.