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Duration IV Sterilization Process Acetabular Inserts

by Howmedica Osteonics Corp.

510(k) K990849

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 NumberK990849 Date20 Dec 1999ClearedStatusActive

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  • Withdrawn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, 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 Duration IV Sterilization Process Acetabular Inserts is a semi-constrained acetabular component designed for hip arthroplasty. Classified under product code LPH as a metal/polymer, porous uncemented prosthesis, it is intended for use in total hip replacement surgeries, providing structural support and articulation within the hip joint.

This device is supplied as a sterile, single-use implant following a validated sterilization process. It is regulated under FDA 510(k) clearance (K990849) and falls under Class II – Special Controls for orthopedic applications. The acetabular inserts are intended for surgical use in controlled environments, adhering to aseptic techniques to ensure patient safety and device integrity.

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