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Mueller Type Femoral Stem

by Osteo Technology, Inc.

510(k) K922864

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 NumberK922864 Date12 Feb 1993ClearedStatusActive

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  • Withdrawn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
JDI
Device Class
Class II
Regulation
21 CFR Part 888.3350
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 27 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 Mueller Type Femoral Stem is an orthopedic device designed for use in hip replacement procedures. It serves as a structural component to replace the femoral head and neck, providing stability and support within the femur.

This device is identified by FDA 510(k) number K922864 and was cleared for use on February 12, 1993. It is manufactured by Osteo Technology, Inc. and is classified under product code JDI.

Other devices from Osteo Technology, Inc.

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Questions

AI-generated answers, 27 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 primary function of the Mueller Type Femoral Stem?

    This device is an orthopedic component designed for hip replacement surgery. It acts as a structural replacement for the femoral head and neck, providing necessary stability and support within the femur.

  • What is the regulatory status of this femoral stem?

    The Mueller Type Femoral Stem is identified by FDA 510(k) number K922864. It was cleared for use on February 12, 1993, under a traditional clearance process and is classified under product code JDI.

  • Who is the manufacturer of this orthopedic device?

    The Mueller Type Femoral Stem is manufactured by Osteo Technology, Inc., located in Timonium, Maryland.