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Zimmer Continuum Acetabular System, Zimmer Trilogy IT Acetabular System

by Zimmer, Inc.

510(k) K091508

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

3 closed

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 NumberK091508 Date11 Sep 2009ClearedStatusActive

Recalls

3 recalls · FDA

    • Terminated Z-0094-2015 FDA Class II initiated 1 Oct 2014 on shared 510(k) K091508

    The affected products are missing polar boss threads.

  • 2 recalls, same reason

    • Terminated Z-0071-2011 FDA Unclassified (pre-2012) initiated 19 Mar 2010 on shared 510(k) K091508
    • Terminated Z-0072-2011 FDA Unclassified (pre-2012) initiated 19 Mar 2010 on shared 510(k) K091508

    The firm has received reports of users encountering difficulties in usage leading to surgical delays or minor damage to a threaded surface of the shell implant.

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  • Withdrawn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) 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, 21 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 Zimmer Continuum Acetabular System and Zimmer Trilogy IT Acetabular System are orthopedic devices designed for acetabular reconstruction in hip arthroplasty. These systems provide hemispherical shells with options for uni-hole, cluster hole, and multi-hole configurations to accommodate varying surgical needs and patient anatomies.

The devices are supplied in sizes ranging from 40-80 mm for uni-hole and multi-hole shells, and 44-80 mm for cluster-hole shells, in 2 mm increments. They are indicated for use in orthopedic surgical settings and were cleared via the FDA 510(k) process under K091508, with product code LPH and advisory committee classification OR (Orthopedic). No sterility, single-use/reusable status, MRI safety, or storage details are provided in the source data.

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Questions

AI-generated answers, 21 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 Zimmer Continuum and Trilogy IT Acetabular System used for?

    The Zimmer Continuum Acetabular System and Zimmer Trilogy IT Acetabular System are orthopedic devices designed for acetabular reconstruction in hip arthroplasty procedures, providing hemispherical shells to restore joint anatomy during surgical implantation.

  • What sizes and configurations are available for the Zimmer Continuum and Trilogy IT shells?

    The shells are supplied in sizes ranging from 40-80 mm for uni-hole and multi-hole configurations, and 44-80 mm for cluster-hole configurations, all in 2 mm increments to accommodate varying patient anatomies and surgical techniques.

  • How was the Zimmer Continuum and Trilogy IT Acetabular System cleared for market?

    The device was cleared via the FDA 510(k) process under K091508 as substantially equivalent to a predicate device, with product code LPH and advisory committee classification OR (Orthopedic), based on the submission review process documented in the authorization data.