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Anatomical Shoulder Inverse/Reverse

by Zimmer GmbH

510(k) K053274

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 NumberK053274 Date25 Jan 2006ClearedStatusActive

Recalls

3 recalls · FDA

  • 2 recalls, same reason

    • Terminated Z-0229-2013 FDA Class II initiated 4 Sep 2012 on shared 510(k) K053274
    • Terminated Z-0231-2013 FDA Class II initiated 4 Sep 2012 on shared 510(k) K053274

    Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur, Switzerland, after receiving four complaints of a discrepancy between product patient labels and product labels with respect to the reference and lot numbers of the product. While the information printed on the product label is correct, the info

    • Terminated Z-0230-2013 FDA Class II initiated 4 Sep 2012 on shared 510(k) K053274

    Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Wintetthur, Switzerland, after receiving four complaints of a discrepancy between product patient labels and product labels with respect to the reference and lot numbers of the product. While the information printed on the product label is correct, the info

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  • Withdrawn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
PHX
Device Class
Class II
Regulation
21 CFR Part 888.3660
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 20 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 Anatomical Shoulder Inverse/Reverse is a reverse shoulder arthroplasty system designed to restore shoulder joint function through altered biomechanics. It reverses the natural relationship between the scapular and humeral components, shifting the center of rotation medially to enhance deltoid muscle leverage and lower the humerus. This design is intended for patients requiring reverse shoulder arthroplasty, particularly those with conditions such as rotator cuff arthropathy or severe glenohumeral osteoarthritis. The system aims to improve range of motion and functional outcomes by replicating a more balanced kinematic profile.

This device is supplied as a surgical implant and is intended for use in orthopedic procedures under sterile conditions. It is classified under the FDA’s product code PHX and received a Traditional 510(k) clearance as Substantially Equivalent to a predicate device. The system is reusable in the context of surgical kits but the individual components are implanted in the patient. No specific MRI safety information is provided, and storage requirements are not detailed in the available data. The device is authorized for use in the United States under the FDA’s regulatory framework.

Other devices from Zimmer, Inc.

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Questions

AI-generated answers, 20 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 specific shoulder conditions is this reverse arthroplasty system intended to address in patients?

    The Anatomical Shoulder Inverse/Reverse system is designed for patients with conditions like rotator cuff arthropathy or severe glenohumeral osteoarthritis where traditional shoulder replacements may not be suitable. Its biomechanical design—reversing the scapular-humeral relationship—aims to restore function by leveraging the deltoid muscle and improving range of motion for better functional outcomes.

  • How is this device supplied, and what are the key considerations for surgical preparation?

    The device is supplied as a surgical implant kit intended for use under sterile conditions. While the system itself is reusable within surgical kits, the individual components are implanted in the patient. Since no MRI safety information is provided, clinicians should confirm compatibility with their facility’s imaging protocols before use.

  • Are there different sizes or models available for this reverse shoulder system, and how would a surgeon determine the appropriate fit for a patient?

    The specifications do not explicitly list sizes or models, but reverse shoulder arthroplasty systems typically offer modular components to accommodate varying patient anatomies. Surgeons would rely on preoperative imaging and the manufacturer’s sizing guides (not detailed here) to select the appropriate components for optimal fit and function.

  • Is this device single-use or reusable, and how should it be handled between cases?

    The system is reusable within surgical kits, meaning components can be sterilized and reused across multiple procedures. However, the implanted components themselves are intended for permanent use in the patient. Proper sterilization and handling protocols (e.g., autoclave or ethylene oxide) must be followed between cases to maintain sterility and functionality.