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Trident Porous Titanium Acetabular Component

by Howmedica Osteonics Corp.

510(k) K010170

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

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 · Traditional NumberK010170 Date18 Apr 2001ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

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  • Withdrawn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
LPH
Device class
Class II
Regulation
21 CFR Part 888.3358
Advisory committee
Orthopedic
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 27 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 Porous Titanium Acetabular Component is a prosthesis for the hip, classified as semi-constrained, metal/polymer, and porous uncemented. It is designed for use in hip joint replacement procedures.

It is supplied as a sterile, single-use device intended for implantation in the acetabulum. The device is authorized under FDA 510(k) clearance K010170 and is classified as Class II with special controls under product code LPH.

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Questions

AI-generated answers, 27 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 Porous Titanium Acetabular Component used for?

    It is a prosthesis designed for use in hip joint replacement procedures, specifically implanted in the acetabulum as part of a semi-constrained, metal/polymer, porous uncemented system to restore joint function.

  • How is the Trident Porous Titanium Acetabular Component supplied and is it reusable?

    It is supplied as a sterile, single-use device intended for one-time implantation only; reuse is not permitted due to sterility and safety requirements following implantation.

  • What regulatory pathway authorized the Trident Porous Titanium Acetabular Component?

    The device received FDA 510(k) clearance under K010170, classified as Class II with special controls under product code LPH, based on a determination of substantial equivalence to a predicate device.