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Anatomical Shoulder Keeled Glenoid

by Zimmer GmbH

510(k) K051623

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 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 NumberK051623 Date19 Jul 2005ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-0226-2013 FDA Class II initiated 4 Sep 2012

    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

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  • Withdrawn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

Overview

AI-generated summary, 23 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 Ke Glenoid is a glenoid component designed for shoulder replacement procedures. It is an anatomically shaped implant intended to replace the damaged or diseased glenoid in the shoulder joint.

This device is supplied as a single-use implant and is not MRI safe. It is authorized under FDA 510K clearance with product code KWS and was cleared on July 19, 2005. The device should be stored according to the manufacturer's instructions and is available in various sizes as specified by the model numbers.

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Questions

AI-generated answers, 23 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 Anatomical Shoulder Ke Glenoid used for?

    The Anatomical Shoulder Ke Glenoid is a glenoid component designed for shoulder replacement procedures. It is intended to replace damaged or diseased glenoid in the shoulder joint, providing anatomically shaped reconstruction.

  • Is the Anatomical Shoulder Ke Glenoid reusable or MRI safe?

    This device is supplied as a single-use implant and is not MRI safe. It should be used only once according to the manufacturer's instructions and cannot be reused for patient safety reasons.

  • What sizes and models are available for the Anatomical Shoulder Ke Glenoid?

    The Anatomical Shoulder Ke Glenoid is available in various sizes as specified by the model numbers. The specific size options should be selected based on patient anatomy and surgical requirements according to the manufacturer's guidelines.

  • How should the Anatomical Shoulder Ke Glenoid be stored?

    The device should be stored according to the manufacturer's instructions to maintain its integrity and sterility until use. Proper storage conditions are essential to ensure the implant remains safe and effective for surgical procedures.

  • What is the regulatory status of the Anatomical Shoulder Ke Glenoid?

    The Anatomical Shoulder Ke Glenoid is authorized under FDA 510K clearance with product code KWS. It was cleared on July 19, 2005, and is classified as substantially equivalent to predicate devices in the orthopedic category.