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Knee Module for the Stealthstation System

by Medtronic Surgical Navigation Technologies

510(k) K012937

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

26 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 NumberK012937 Date25 Jan 2002ClearedStatusActive

Recalls

26 recalls · FDA

  • 25 recalls, same reason

    • Terminated Z-1587-2014 FDA Class II initiated 24 Apr 2014
    • Terminated Z-1581-2014 FDA Class II initiated 24 Apr 2014
    • Terminated Z-1582-2014 FDA Class II initiated 24 Apr 2014
    • Terminated Z-1600-2014 FDA Class II initiated 24 Apr 2014
    • Terminated Z-1584-2014 FDA Class II initiated 24 Apr 2014
    • Terminated Z-1601-2014 FDA Class II initiated 24 Apr 2014
    • Terminated Z-1578-2014 FDA Class II initiated 24 Apr 2014
    • Terminated Z-1580-2014 FDA Class II initiated 24 Apr 2014
    • Terminated Z-1591-2014 FDA Class II initiated 24 Apr 2014
    • Terminated Z-1590-2014 FDA Class II initiated 24 Apr 2014
    • Terminated Z-1595-2014 FDA Class II initiated 24 Apr 2014
    • Terminated Z-1594-2014 FDA Class II initiated 24 Apr 2014
    • Terminated Z-1593-2014 FDA Class II initiated 24 Apr 2014
    • Terminated Z-1596-2014 FDA Class II initiated 24 Apr 2014
    • Terminated Z-1598-2014 FDA Class II initiated 24 Apr 2014
    • Terminated Z-1592-2014 FDA Class II initiated 24 Apr 2014
    • Terminated Z-1589-2014 FDA Class II initiated 24 Apr 2014
    • Terminated Z-1585-2014 FDA Class II initiated 24 Apr 2014
    • Terminated Z-1579-2014 FDA Class II initiated 24 Apr 2014
    • Terminated Z-1602-2014 FDA Class II initiated 24 Apr 2014
    • Terminated Z-1583-2014 FDA Class II initiated 24 Apr 2014 on shared 510(k) K012937
    • Terminated Z-1599-2014 FDA Class II initiated 24 Apr 2014
    • Terminated Z-1588-2014 FDA Class II initiated 24 Apr 2014 on shared 510(k) K012937
    • Terminated Z-1597-2014 FDA Class II initiated 24 Apr 2014
    • Terminated Z-1586-2014 FDA Class II initiated 24 Apr 2014

    Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage to ensure sterility.

    • Terminated Z-0231-04 FDA Unclassified (pre-2012) initiated 31 Oct 2003

    Surgical devices intended for single use were not labeled for single use.

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
HAW
Device Class
Class II
Regulation
21 CFR Part 882.4560
Advisory Committee
Neurology
FDA Decision
SESE Substantially Equivalent

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