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Pro-Femur R

by Wrightmedicaltechnologyinc 510(k)

Active United States

510(k) K003016

Regulatory status

as of 28 Oct 2026

Recall ongoing. 1 ongoing FDA recall. See recalls

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Abbreviated NumberK003016 Date13 Dec 2000ClearedStatusActive

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

9 recalls · 1 ongoing · FDA

    • Ongoing Z-2948-2020 FDA Class II initiated 31 Jul 2020

    MicroPort Orthopedics Inc. is voluntarily recalling any existing inventory of PROFEMUR Titanium and Cobalt Chrome modular necks with previous package insert versions to replace the PROFEMUR Hip System Package Insert with the most recent revision (150803-8).

  • 2 recalls, same reason

    • Terminated Z-2942-2020 FDA Class I initiated 31 Jul 2020
    • Terminated Z-2941-2020 FDA Class I initiated 31 Jul 2020

    MicroPort Orthopedics Inc. states that there have been reports of fractures of the long and extra-long Titanium modular femoral neck component after implantation. Worldwide there were 680 Long and X-Long PROFEMUR Titanium modular neck fractures among 123,840 global sales representing is a cumulative rate of modular neck device fracture of 0.55% from 2002 to 2019. Within the United States there were 349 Long and X-Long PROFEMUR Titanium modular neck fractures among 15,786 United States sales representing a cumulative rate of modular neck device fracture with a fracture rate in the United States of 2.21% from 2002 to 2019. There is an average time of 5.4 years to device fracture after implantation.

    • Terminated Z-2588-2016 FDA Class II initiated 30 Jun 2016

    Profemur(R) neck, Item Number PHA01222 (Short AR VV2 Ti Neck) was labeled as Item Number PHA01212 (Short AR VV1 Ti Neck).

  • 3 recalls, same reason

    • Terminated Z-0184-2013 FDA Class II initiated 5 Sep 2012 via K003016, on the same 510(k)
    • Terminated Z-0185-2013 FDA Class II initiated 5 Sep 2012 via K003016, on the same 510(k)
    • Terminated Z-0183-2013 FDA Class II initiated 5 Sep 2012 via K003016, on the same 510(k)

    There may be inaccuracies on the labeled shelf life on all products packaged at the Toulon, France facility.

  • 2 recalls, same reason

    • Terminated Z-0867-2007 FDA Unclassified (pre-2012) initiated 27 Mar 2007 via K003016, on the same 510(k)
    • Terminated Z-0868-2007 FDA Unclassified (pre-2012) initiated 27 Mar 2007 via K003016, on the same 510(k)

    The titanium plasma coating was found to have missing fragments.

Recalls marked "via" name another device cleared under the same FDA submission as this one.

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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