Skip to content

Maxtorque Mini Cannulated Screw System

by Orthohelix Surgical Designs, Inc.

510(k) K082574

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

3 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 · Special NumberK082574 Date8 Dec 2008ClearedStatusActive

Recalls

3 recalls · FDA

  • 2 recalls, same reason

    • Terminated Z-0026-2013 FDA Class II initiated 29 Jan 2010
    • Terminated Z-0027-2013 FDA Class II initiated 29 Jan 2010

    The tips of the drivers are breaking while being used to drive the screws into patients.

    • Terminated Z-1430-2010 FDA Unclassified (pre-2012) initiated 3 Sep 2009 on shared 510(k) K082574

    The epoxy is flaking off the drill bits and countersinks.

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  • Withdrawn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

Other devices from Orthohelix Surgical Designs, Inc.

See all devices from Orthohelix Surgical Designs, Inc. →