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Echo Bi-Metric Press-Fit Stems

by Biomet Manufacturing Corp

510(k) K070274

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 · Special NumberK070274 Date3 Apr 2007ClearedStatusActive

Recalls

3 recalls · FDA

    • Terminated Z-2821-2018 FDA Class II initiated 8 Jun 2018

    Two lots of the Echo BI-Metric Hip Stem and ARCOS Modular Revision Hip Stem may have been comingled. Potential health consequences include extension of surgery time to find a replacement component.

    • Terminated Z-0300-2018 FDA Class II initiated 5 Jun 2017

    Possibility that the patient label inside the product box was incorrectly labeled. The outer box label and actual product are correctly identified but the internal patient label could be incorrect.

    • Terminated Z-0442-2013 FDA Class II initiated 6 Nov 2012

    It was reported that the surgeon noticed that the Echo 11mm hip stem had an etching indicating it was 13mm stem.

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  • Withdrawn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
KWA
Device Class
Class III
Regulation
21 CFR Part 888.3330
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 18 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 Echo Bi-Metric Press-Fit Stems are classified as Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component). These devices are designed as femoral components intended for use in total hip arthroplasty, providing a semi-constrained metal-on-metal articulation to facilitate hip joint replacement. The stems are engineered for press-fit fixation into the femoral canal, ensuring stable integration without the need for cement.

These stems are supplied as reusable medical devices and are intended for use in orthopedic surgical settings. Constructed from forged titanium alloy, they feature either Interlok® grit-blasted or PPS® Porous Plasma Sprayed surfaces to enhance osseointegration. The devices are regulated under 21 CFR 888.3330 and hold an FDA 510(k) clearance (K070274) with a classification as Class III. Multiple model references are available, as listed in the regulatory submission.

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