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Avenir Muller Stem

by Zimmer GmbH

510(k) K123392

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

4 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 NumberK123392 Date4 Mar 2013ClearedStatusActive

Recalls

4 recalls · FDA

    • Terminated Z-0644-2019 FDA Class II initiated 31 Oct 2018

    Mislabeled Labeled Avenir Mller Stem size 1, the stem inside the packaging is an Avenir Mller Stem size 2 .

  • 2 recalls, same reason

    • Terminated Z-1524-2018 FDA Class II initiated 28 Feb 2018
    • Terminated Z-1525-2018 FDA Class II initiated 28 Feb 2018

    A potential commingle that could result in the product in the package not matching the product on the outer label.

    • Terminated Z-2292-2016 FDA Class II initiated 30 Jun 2016

    Product mix-up. The Avenir Mller Stem 6 lateral uncemented might be placed in the packaging of the Avenir Mller Stem 4 standard uncemented and vice versa. Potential for delay in surgery, and/or potential for use of incorrect implant which may in turn lead dismetry in patient and possibly the need for revision.

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  • Withdrawn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
LZO
Device class
Class II
Regulation
21 CFR Part 888.3353
Advisory committee
Orthopedic
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Avenir Müller Stem is a cemented hip stem classified under the FDA’s orthopedic product code LZO. It is a straight, double-tapered design manufactured from Protasul®-S30 stainless steel, intended for use in hemi or total hip arthroplasty (THA). The stem features a 12/14 taper interface for articulation with compatible ball heads, ensuring compatibility with approved hip replacement components. Its construction prioritises stability and fit within the femoral canal for long-term implant integration.

This device is supplied as a reusable surgical implant, requiring proper sterilisation before use. It is intended for use in orthopaedic settings by trained surgeons during primary or revision hip replacement procedures. The Avenir Müller Stem holds FDA 510(k) clearance (K123392) under the Traditional 510(k) review pathway, with a decision date of March 4, 2013. Storage and handling must adhere to manufacturer guidelines to maintain sterility and structural integrity prior to implantation.

Other devices from Zimmer, Inc.

See all devices from Zimmer, Inc. →

Questions

AI-generated answers, 1 Oct 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 Avenir Müller Stem used for?

    The Avenir Müller Stem is designed for use in hemi or total hip arthroplasty (THA), serving as a cemented implant within the femoral canal. Its straight, double-tapered stainless steel construction ensures stability and long-term integration, making it suitable for both primary and revision procedures.

  • How is the Avenir Müller Stem supplied and prepared for use?

    The Avenir Müller Stem is supplied as a reusable surgical implant. Before use, it must undergo proper sterilisation to ensure safety and sterility. Adherence to manufacturer guidelines for storage and handling is critical to maintain its structural integrity and sterility prior to implantation.

  • What taper interface does the Avenir Müller Stem use for articulation?

    The Avenir Müller Stem features a 12/14 taper interface, which allows it to articulate with compatible ball heads for hip replacement procedures. This design ensures compatibility with approved hip replacement components, facilitating proper function and fit.

  • Is the Avenir Müller Stem single-use or reusable?

    The Avenir Müller Stem is intended for reuse after proper sterilisation. It is not designed as a single-use device, so it must be cleaned, sterilised, and stored according to manufacturer instructions to maintain its performance and safety for subsequent procedures.

  • What regulatory pathway does the Avenir Müller Stem follow?

    The Avenir Müller Stem holds FDA 510(k) clearance under the Traditional 510(k) review pathway, classified under product code LZO for orthopedic devices. The clearance decision was made on March 4, 2013, confirming its substantial equivalence to a predicate device.