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Trident Hemispherical Acetabular Shells

by Howmedica Osteonics Corp.

510(k) K013676

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 NumberK013676 Date5 Dec 2001ClearedStatusActive

Recalls

8 recalls · FDA

  • 7 recalls, same reason

    • Terminated Z-1172-2008 FDA Unclassified (pre-2012) initiated 21 Jan 2008
    • Terminated Z-1170-2008 FDA Unclassified (pre-2012) initiated 21 Jan 2008
    • Terminated Z-1171-2008 FDA Unclassified (pre-2012) initiated 21 Jan 2008
    • Terminated Z-1174-2008 FDA Unclassified (pre-2012) initiated 21 Jan 2008
    • Terminated Z-1169-2008 FDA Unclassified (pre-2012) initiated 21 Jan 2008
    • Terminated Z-1173-2008 FDA Unclassified (pre-2012) initiated 21 Jan 2008
    • Terminated Z-1168-2008 FDA Unclassified (pre-2012) initiated 21 Jan 2008

    Foreign material: Some of the parts tested exceeded Stryker Orthopaedics internal acceptance criteria for manufacturing residuals.

    • Terminated Z-1685-2009 FDA Unclassified (pre-2012) initiated 29 May 2007

    Stryker Orthopaedics became aware that Trident Hemispherical Shells, Catalog Number 508-11-74J, are actually marked and labeled as Catalog Number 598-11-72J, Lot Code 20282301

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  • Withdrawn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, 1 Oct 2026

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

The Trident Hemispherical Acetabular Shells are classified as Prosthesis, Hip, Semi-Constrained, Uncemented, and consist of a metal/polymer construction with a non-porous surface and calcium phosphate coating. These devices are designed to provide structural support and articulation within the acetabulum during total hip arthroplasty, facilitating load-bearing and joint stability. Their hemispherical shape ensures conformance to the femoral head, promoting natural movement patterns while minimizing stress concentrations.

Intended for single-use, these shells are implanted via cementless fixation into the prepared acetabulum during orthopedic surgery. They are supplied sterile and require no additional sterilization before use. The devices are regulated under FDA 510(k) clearance (K013676) as a Class II – Special Control product, adhering to orthopedic surgical standards. Sizes and configurations are determined by preoperative planning to match patient anatomy, ensuring proper fit and function.

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Questions

AI-generated answers, 1 Oct 2026

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

  • What is the Trident Hemispherical Acetabular Shell designed for?

    The Trident Hemispherical Acetabular Shell is designed for use in total hip arthroplasty (replacement surgery) to provide structural support and articulation within the acetabulum. Its hemispherical shape ensures a conforming fit to the femoral head, promoting natural movement patterns while distributing load evenly to reduce stress concentrations. The semi-constrained design enhances joint stability during weight-bearing activities.

  • How are these shells fixed in place during surgery?

    These shells are implanted via cementless fixation, meaning they rely on direct contact with the patient’s bone and a calcium phosphate coating to integrate over time. No bone cement is required, and the surface is non-porous, which helps facilitate this biological fixation process during the healing phase after surgery.

  • Are the Trident Hemispherical Acetabular Shells reusable or single-use?

    The Trident Hemispherical Acetabular Shells are intended for single-use only. They are supplied sterile and are not designed to be sterilized or reused after implantation. This ensures patient safety and maintains device integrity for optimal performance during surgery.

  • What materials and coatings are used in these shells?

    The shells are constructed from a metal/polymer combination and feature a non-porous surface with a calcium phosphate coating. The coating aids in promoting osseointegration—where the bone grows directly onto the shell—enhancing long-term stability and fixation in the acetabulum.

  • How are sizes and configurations determined for these shells?

    Sizes and configurations are selected based on preoperative planning and imaging to match the patient’s specific acetabular anatomy. This ensures a precise fit, optimizing joint function, load distribution, and overall surgical outcomes. Customization is critical to accommodate individual anatomical variations.