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Dynasty Porous Acetabular Shell, Dynasty Polyethylene Acetabular Liner, Dynasty Metal Acetabular Liner

by Wrightmedicaltechnologyinc

510(k) K082924

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

17 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 NumberK082924 Date6 Mar 2009ClearedStatusActive

Recalls

17 recalls · FDA

  • 16 recalls, same reason

    • Terminated Z-1016-2012 FDA Not yet classified initiated 3 Jan 2012
    • Terminated Z-1017-2012 FDA Not yet classified initiated 3 Jan 2012
    • Terminated Z-1020-2012 FDA Not yet classified initiated 3 Jan 2012
    • Terminated Z-1029-2012 FDA Not yet classified initiated 3 Jan 2012
    • Terminated Z-1022-2012 FDA Not yet classified initiated 3 Jan 2012
    • Terminated Z-1025-2012 FDA Not yet classified initiated 3 Jan 2012
    • Terminated Z-1021-2012 FDA Not yet classified initiated 3 Jan 2012
    • Terminated Z-1027-2012 FDA Not yet classified initiated 3 Jan 2012
    • Terminated Z-1031-2012 FDA Not yet classified initiated 3 Jan 2012
    • Terminated Z-1030-2012 FDA Not yet classified initiated 3 Jan 2012
    • Terminated Z-1028-2012 FDA Not yet classified initiated 3 Jan 2012
    • Terminated Z-1023-2012 FDA Not yet classified initiated 3 Jan 2012
    • Terminated Z-1018-2012 FDA Not yet classified initiated 3 Jan 2012
    • Terminated Z-1024-2012 FDA Not yet classified initiated 3 Jan 2012
    • Terminated Z-1019-2012 FDA Not yet classified initiated 3 Jan 2012
    • Terminated Z-1026-2012 FDA Not yet classified initiated 3 Jan 2012

    The possibility exists that particulate debris from the packaging spacer could be unintentionally implanted into a patient and could potentially lead to complications that might necessitate a revision surgery.

    • Terminated Z-2212-2010 FDA Unclassified (pre-2012) initiated 7 Jun 2010 on shared 510(k) K082924

    The inner and outer product packaging was missing the following information: shelf life, translations, manufacturing date, CE marking and also listed the incorrect sterilization method.

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
KWA
Device Class
Class III
Regulation
21 CFR Part 888.3330
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Dynasty Porous Acetabular Shell, Dynasty Polyethylene Acetabular Liner, and Dynasty Metal Acetabular Liner are components of a semi-constrained hip prosthesis designed for uncemented fixation. These devices are classified as Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component) and are intended for use in total hip arthroplasty procedures. The acetabular shell provides structural support, while the liners—polyethylene and metal—offer articulation surfaces for the femoral head, facilitating joint movement.

These components are supplied as part of a modular acetabular system, intended for use in orthopedic settings by trained surgeons. The acetabular shell is uncemented and porous, designed for osseointegration, while the liners are supplied sterile for single-use. The system is regulated under FDA 510(k) clearance (K082924) and adheres to device class III standards. Multiple sizes and configurations are available, as indicated by the registration numbers, to accommodate varying anatomical requirements.

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