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Excia Total Hip System

by Aesculap, Inc.

510(k) K042344

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

10 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 · Abbreviated NumberK042344 Date16 Mar 2005ClearedStatusActive

Recalls

10 recalls · FDA

  • 10 recalls, same reason

    • Terminated Z-0440-2008 FDA Unclassified (pre-2012) initiated 10 Oct 2007
    • Terminated Z-0439-2008 FDA Unclassified (pre-2012) initiated 10 Oct 2007
    • Terminated Z-0436-2008 FDA Unclassified (pre-2012) initiated 10 Oct 2007
    • Terminated Z-0441-2008 FDA Unclassified (pre-2012) initiated 10 Oct 2007
    • Terminated Z-0444-2008 FDA Unclassified (pre-2012) initiated 10 Oct 2007
    • Terminated Z-0443-2008 FDA Unclassified (pre-2012) initiated 10 Oct 2007
    • Terminated Z-0437-2008 FDA Unclassified (pre-2012) initiated 10 Oct 2007
    • Terminated Z-0438-2008 FDA Unclassified (pre-2012) initiated 10 Oct 2007
    • Terminated Z-0445-2008 FDA Unclassified (pre-2012) initiated 10 Oct 2007
    • Terminated Z-0442-2008 FDA Unclassified (pre-2012) initiated 10 Oct 2007

    Sterility (package integrity) Compromised: Device package damaged during shipment

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  • Withdrawn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
LWJ
Device Class
Class II
Regulation
21 CFR Part 888.3360
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

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