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Hip Joint Femoral (Hemi-Hip) Metal/Polymer Cemented or Uncemented Prosthesis

by Encore Orthopedics, Inc.

510(k) K953510

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

18 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 NumberK953510 Date9 Aug 1995ClearedStatusActive

Recalls

18 recalls · FDA

  • 13 recalls, same reason

    • Terminated Z-0098-2008 FDA Unclassified (pre-2012) initiated 2 Aug 2007
    • Terminated Z-0091-2008 FDA Unclassified (pre-2012) initiated 2 Aug 2007
    • Terminated Z-0094-2008 FDA Unclassified (pre-2012) initiated 2 Aug 2007
    • Terminated Z-0095-2008 FDA Unclassified (pre-2012) initiated 2 Aug 2007
    • Terminated Z-0089-2008 FDA Unclassified (pre-2012) initiated 2 Aug 2007
    • Terminated Z-0088-2008 FDA Unclassified (pre-2012) initiated 2 Aug 2007
    • Terminated Z-0090-2008 FDA Unclassified (pre-2012) initiated 2 Aug 2007
    • Terminated Z-0092-2008 FDA Unclassified (pre-2012) initiated 2 Aug 2007
    • Terminated Z-0099-2008 FDA Unclassified (pre-2012) initiated 2 Aug 2007
    • Terminated Z-0087-2008 FDA Unclassified (pre-2012) initiated 2 Aug 2007
    • Terminated Z-0097-2008 FDA Unclassified (pre-2012) initiated 2 Aug 2007
    • Terminated Z-0093-2008 FDA Unclassified (pre-2012) initiated 2 Aug 2007
    • Terminated Z-0096-2008 FDA Unclassified (pre-2012) initiated 2 Aug 2007

    Device mislabeled; hip prosthesis components validated for 5 years were labeled as having a 6 year expiration date.

  • 5 recalls, same reason

    • Terminated Z-0085-2008 FDA Unclassified (pre-2012) initiated 2 Aug 2007
    • Terminated Z-0084-2008 FDA Unclassified (pre-2012) initiated 2 Aug 2007
    • Terminated Z-0083-2008 FDA Unclassified (pre-2012) initiated 2 Aug 2007
    • Terminated Z-0082-2008 FDA Unclassified (pre-2012) initiated 2 Aug 2007
    • Terminated Z-0086-2008 FDA Unclassified (pre-2012) initiated 2 Aug 2007

    Device mislabeled. Hip prosthesis components validated for 5 years were labeled as having a 6 year expiration date.

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  • Withdrawn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
KWY
Device Class
Class II
Regulation
21 CFR Part 888.3390
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

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