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Super Secur-Fit HA Hip Stems and Super Secur-Fit Plus HA Hip Stems

by Howmedica Osteonics Corp.

510(k) K020615

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 NumberK020615 Date13 May 2002ClearedStatusActive

Recalls

8 recalls · FDA

  • 2 recalls, same reason

    • Terminated Z-0556-2010 FDA Unclassified (pre-2012) initiated 14 Jan 2009
    • Terminated Z-0557-2010 FDA Unclassified (pre-2012) initiated 14 Jan 2009

    Stryker Orthopaedics became aware that there may be difficulty in mating stem to implantation/extraction instrument.

  • 6 recalls, same reason

    • Terminated Z-1385-2009 FDA Unclassified (pre-2012) initiated 6 Jan 2009
    • Terminated Z-1680-2009 FDA Unclassified (pre-2012) initiated 6 Jan 2009
    • Terminated Z-1387-2009 FDA Unclassified (pre-2012) initiated 6 Jan 2009
    • Terminated Z-1386-2009 FDA Unclassified (pre-2012) initiated 6 Jan 2009
    • Terminated Z-1384-2009 FDA Unclassified (pre-2012) initiated 6 Jan 2009
    • Terminated Z-1383-2009 FDA Unclassified (pre-2012) initiated 6 Jan 2009

    Product deviation : Specific lots of sprayed HA hip stems did not meet Stryker's Internal Material Specification for tensile bond strength and crystallinity.

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  • Withdrawn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
MEH
Device Class
Class II
Regulation
21 CFR Part 888.3353
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 20 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 Super Secur-Fit HA Hip Stems and Super Secur-Fit Plus HA Hip Stems are cementless, modular orthopedic implants designed for total hip arthroplasty. These devices replace the femoral component of the hip joint, providing a stable fixation within the proximal femur. Constructed as single-use metal stems, they are intended for both primary and revision surgeries to restore hip function and mobility. The design emphasizes secure fixation without the use of bone cement, ensuring long-term stability.

These stems are supplied sterile and intended for single-use only, adhering to standard orthopedic surgical protocols. They are classified under product code MEH and were cleared via a Special 510(k) submission, affirming substantial equivalence to a predicate device. The devices are not explicitly noted for MRI safety or special handling beyond standard orthopedic implant procedures. Storage and handling follow general surgical instrument protocols to maintain sterility and integrity prior to use.

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Questions

AI-generated answers, 20 Sep 2026

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

  • Are these hip stems reusable in the operating room, or are they intended for single-use only?

    These devices are explicitly intended for single-use only, as stated in the description. They are supplied sterile and follow standard orthopedic surgical protocols that assume disposable use to prevent contamination and ensure patient safety.

  • What types of surgeries are these hip stems approved for, and how do they differ in application?

    The Super Secur-Fit HA and Super Secur-Fit Plus HA Hip Stems are designed for both primary (initial) and revision (repeat) total hip arthroplasty surgeries. The key difference lies in their modular design and cementless fixation, which aims to provide stable, long-term support within the femur without relying on bone cement.

  • How should these hip stems be stored before use to maintain their sterility and integrity?

    Storage follows general orthopedic surgical instrument protocols to preserve sterility and structural integrity. Since they are single-use and sterile upon supply, they should be kept in their original packaging until immediately before use, avoiding exposure to moisture, contamination, or physical damage.

  • Are there any special considerations for handling these implants beyond standard orthopedic procedures?

    No special handling instructions beyond standard orthopedic implant protocols are mentioned. They are not explicitly noted for MRI safety, so their use in MRI environments should be evaluated on a case-by-case basis with appropriate imaging protocols. Always follow manufacturer guidelines for surgical preparation.