Skip to content

Modular Foot System

by Orthohelix Surgical Designs, Inc.

510(k) K073624

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

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 NumberK073624 Date20 Mar 2008ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-1784-2010 FDA Unclassified (pre-2012) initiated 23 Mar 2010 on shared 510(k) K073624

    On 3/9/10 it was discovered that the recalling firm packaged MFT-021-35-24 Screws from lot 0964092 as MFT-021-35-22 lot 0964081.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

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  • Withdrawn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
HRS
Device Class
Class II
Regulation
21 CFR Part 888.3030
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Other devices from Orthohelix Surgical Designs, Inc.

See all devices from Orthohelix Surgical Designs, Inc. →