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Modification to Depuy Delta Xtend Reverse Shoulder System

by Depuy Orthopaedics, Inc.

510(k) K081620

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

8 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 NumberK081620 Date30 Jun 2008ClearedStatusActive

Recalls

8 recalls · FDA

  • 8 recalls, same reason

    • Terminated Z-0537-2009 FDA Unclassified (pre-2012) initiated 10 Jul 2008
    • Terminated Z-0538-2009 FDA Unclassified (pre-2012) initiated 10 Jul 2008
    • Terminated Z-0536-2009 FDA Unclassified (pre-2012) initiated 10 Jul 2008
    • Terminated Z-0533-2009 FDA Unclassified (pre-2012) initiated 10 Jul 2008
    • Terminated Z-0532-2009 FDA Unclassified (pre-2012) initiated 10 Jul 2008
    • Terminated Z-0535-2009 FDA Unclassified (pre-2012) initiated 10 Jul 2008
    • Terminated Z-0534-2009 FDA Unclassified (pre-2012) initiated 10 Jul 2008
    • Terminated Z-0539-2009 FDA Unclassified (pre-2012) initiated 10 Jul 2008

    Compressed air may become trapped between the cup and the stem, preventing the tapered walls from engaging and causing the cup to feel unstable.

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  • Withdrawn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
KWS
Device Class
Class II
Regulation
21 CFR Part 888.3660
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

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