Skip to content

Continuum® Trabecular Metal™ 00-8757-056-02

by Zimmer, Inc.

Active United States. Also listed in GUDID (US).

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 GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00889024151444 UDI-DI Date17 Sep 2015ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK151448 Date13 Aug 2015DecidedStatusActive

Recalls

3 recalls · FDA

    • Terminated Z-0094-2015 FDA Class II initiated 1 Oct 2014

    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  • Withdrawn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

GUDID

Trade name
Continuum® Trabecular Metal™
Generic name
Acetabular shell
Model / Ref / Catalog
00-8757-056-02
Primary DI / UDI-DI
00889024151444
510(k) Number
FDA product code
LPH, JDI, LZO
GMDN term
Acetabular shell
Device class
Class II
Regulation number
888.3358, 888.3350, 888.3353
GUDID distribution status
In Commercial Distribution
Size
Outer Diameter — 56 Millimeter

Related devices

Category: Acetabular shell

Cleared under the same submission (K091508)

Show all (12)

Cleared under the same submission (K151448)

Show all (12)

Other devices from Zimmer, Inc.

See all devices from Zimmer, Inc. →

Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
  • Expiration date

Other properties (9)

  • Sterilise before use: No
  • Contains latex: No
  • Over-the-counter: No
  • Convenience kit: No
  • Combination product: No
  • HCT/P: No
  • Premarket exempt: No
  • Serial number: No
  • Manufacturing date: No