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Trident Ceramic on Ceramic Acetabular System

by Howmedica Osteonics Corp.

PMA P000013510(k) K033716

Active United States

PMA 510(k)

Valid until

No expiry

FDA authorization is not time-limited

FDA recalls

None ongoing

3 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), FDA PMA, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK033716 Date10 Feb 2005ClearedStatusActive
United StatesFDA PMA PMA NumberP000013 Date3 Feb 2003ApprovedStatusActive

Recalls

3 recalls · FDA

    • Terminated Z-2810-2015 FDA Class II initiated 25 Jun 2015

    it was discovered that item 623-10-36I Lot 3Y0KHP, although meeting all device specifications, was determined to be unacceptable due to a documentation issue. However the parts were inadvertently shipped to the field.

    • Terminated Z-1703-2009 FDA Unclassified (pre-2012) initiated 9 Jun 2009 on shared PMA P000013

    The Surgical Protocol has been modified to create separate and distinct surgical protocols, one for the Trident PSL Shell (LSP68) and one for the Trident Hemispherical Shell (LSP69) in order to clarify and highlight the differences in reaming technique.

    • Terminated Z-0909-2010 FDA Unclassified (pre-2012) initiated 17 Feb 2006

    Stryker Orthopaedics became aware of a potential anomaly related to the packaging process of referenced lots of X# polyethylene used on Scorpio, Triathlon and Trident inserts.

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  • Withdrawn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), FDA PMA Active

Specification

510(k) · PMA

Trade name
Trident System
Generic name
Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
PMA number
510(k) Number
FDA product code
LPH
Device class
Class II
Regulation
21 CFR Part 888.3358
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 Trident Ceramic on Ceramic Acetabular System is a semi-constrained hip prosthesis designed for use in primary total hip arthroplasty. It is indicated for patients suffering from painful, disabling joint disease of the hip caused by non-inflammatory degenerative arthritis, including conditions such as osteoarthritis, avascular necrosis, and traumatic arthritis.

This system is manufactured by Howmedica Osteonics Corp and is authorized for use under FDA 510(k) and PMA regulatory pathways. It is suitable for patients requiring surgical intervention for hip joint failure resulting from various fractures or developmental conditions like slipped capital epiphysis. The device is categorized as a metal and ceramic semi-constrained hip prosthesis for cemented or uncemented application.

From the manufacturer

The HOWMEDICA OSTEONICS TRIDENT and. TRITANIUM Acetabular Shells are intended for cementless use only. Dome hole plug is indicated for cementless hip.

Source: stryker.com

Other devices from Howmedica Osteonics Corp.

See all devices from Howmedica Osteonics Corp. →

Questions

AI-generated answers, 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.

  • What is the Trident Ceramic on Ceramic Acetabular System used for?

    This device is a semi-constrained hip prosthesis indicated for patients undergoing primary total hip arthroplasty to address painful, disabling joint disease resulting from non-inflammatory degenerative arthritis.

  • Which medical conditions are treated with this system?

    The system is indicated for conditions including osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, pelvic or femoral fractures, failed fracture fixation, and diastrophic variants.

  • Is the Trident Acetabular System FDA authorized?

    Yes, the device is authorized for clinical use under FDA 510(k) and PMA regulatory pathways, as indicated by the provided regulatory documentation.