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Trident Large Diameter Acetabular Inserts

by Howmedica Osteonics Corp.

510(k) K062419

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 NumberK062419 Date15 Nov 2006ClearedStatusActive

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  • Withdrawn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, 24 Sep 2026

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

Trident Large Diameter Acetabular Inserts are hip prosthesis components classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented under product code LPH. These inserts are designed to accommodate cobalt chrome femoral heads and are part of a hip arthroplasty system.

The inserts are available in 40mm and 44mm inner diameter sizes and are supplied as sterile, single-use devices. They received FDA 510(k) clearance (K062419) as substantially equivalent to previously cleared devices and are intended for use in orthopedic hip replacement procedures under special controls for Class II medical devices.

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Questions

AI-generated answers, 24 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 Large Diameter Acetabular Insert used for?

    The Trident Large Diameter Acetabular Insert is a hip prosthesis component designed to accommodate cobalt chrome femoral heads in orthopedic hip replacement procedures, functioning as a semi-constrained metal/polymer porous uncemented implant under product code LPH.

  • How is the Trident Large Diameter Acetabular Insert supplied and is it reusable?

    The insert is supplied as a sterile, single-use device, meaning it is intended for one patient and one procedure only, and must not be reprocessed or reused due to risks of contamination, material degradation, and compromised structural integrity.

  • What sizes are available for the Trident Large Diameter Acetabular Insert?

    The Trident Large Diameter Acetabular Insert is available in two inner diameter sizes: 40mm and 44mm, specifically designed to match corresponding cobalt chrome femoral heads within the Trident hip arthroplasty system.

  • What regulatory pathway was used for the Trident Large Diameter Acetabular Insert?

    The device received FDA 510(k) clearance under submission number K062419, demonstrating substantial equivalence to a predicate device, and is classified as a Class II medical device subject to special controls under product code LPH.