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Total and Hemi Shoulder System

by Dvo Extremity Solutions, LLC 510(k)

Active United States

510(k) K060988

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK060988 Date6 Dec 2006ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

13 recalls · FDA

  • 11 recalls, same reason

    • Terminated Z-0822-2009 FDA Unclassified (pre-2012) initiated 20 Oct 2008
    • Terminated Z-0821-2009 FDA Unclassified (pre-2012) initiated 20 Oct 2008
    • Terminated Z-0825-2009 FDA Unclassified (pre-2012) initiated 20 Oct 2008
    • Terminated Z-0818-2009 FDA Unclassified (pre-2012) initiated 20 Oct 2008
    • Terminated Z-0826-2009 FDA Unclassified (pre-2012) initiated 20 Oct 2008
    • Terminated Z-0819-2009 FDA Unclassified (pre-2012) initiated 20 Oct 2008
    • Terminated Z-0820-2009 FDA Unclassified (pre-2012) initiated 20 Oct 2008
    • Terminated Z-0823-2009 FDA Unclassified (pre-2012) initiated 20 Oct 2008
    • Terminated Z-0824-2009 FDA Unclassified (pre-2012) initiated 20 Oct 2008
    • Terminated Z-0828-2009 FDA Unclassified (pre-2012) initiated 20 Oct 2008
    • Terminated Z-0827-2009 FDA Unclassified (pre-2012) initiated 20 Oct 2008

    Tornier, Medical has received a report of a mislabeled sterile AFFINITI head product. As a result, Tornier has decided to voluntarily recall the potentially affected lots, including two (2) lots of AFFINITI Stems.

  • 2 recalls, same reason

    • Terminated Z-0830-2009 FDA Unclassified (pre-2012) initiated 20 Oct 2008
    • Terminated Z-0829-2009 FDA Unclassified (pre-2012) initiated 20 Oct 2008

    Tornier, Medical has received on report of a mislabeled sterile AFFINITI head product. As a result, Tornier has decided to voluntarily recall the potentially affected lots, including two (2) lots of AFFINITI Stems.

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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