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APEX MODULAR HEAD, SIZE 28, 32, 26 AND 40 MM+10.5 OFFSET - 304010

by Omnlife Science

510(k) K101575

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 25 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK101575 Date30 Jun 2010ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 25 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  • Withdrawn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
Models / Variants
304010
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.

The Apex Modular Head is a prosthetic component for total hip replacement systems that provides a +10.5mm offset option for 28, 32, 36, and 40mm head diameters. It is manufactured from wrought cobalt chromium and utilizes a standard taper design.

This device is supplied in multiple sizes and models as specified. It is authorized under FDA 510K clearance with product code LPH. The device is intended for use in hip replacement procedures and is subject to regulatory oversight as a Class II medical device.

Other devices from Omnlife Science

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 Apex Modular Head used for?

    The Apex Modular Head is a prosthetic component designed for total hip replacement systems, offering a +10.5mm offset option for various head diameters to help optimize hip reconstruction outcomes.

  • What sizes and models are available for the Apex Modular Head?

    The Apex Modular Head is available in multiple sizes including 28mm, 32mm, 36mm, and 40mm head diameters, with corresponding models 302810, 303210, 303610, and 304010.

  • Is the Apex Modular Head single-use or reusable?

    The device is intended for single use in hip replacement procedures. It is manufactured from wrought cobalt chromium with a standard taper design and should not be reused according to standard medical device protocols.

  • What is the regulatory status of the Apex Modular Head?

    The Apex Modular Head is authorized under FDA 510K clearance with product code LPH, classified as a Class II medical device, and is subject to regulatory oversight for hip replacement procedures.