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GMK Sphere Revision

by Medacta International S.A.

510(k) K211664

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 NumberK211664 Date29 Jul 2021ClearedStatusActive

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  • Withdrawn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
JWH
Device Class
Class II
Regulation
21 CFR Part 888.3560
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 GMK Sphere Revision is a knee prosthesis system designed to address ligament instability and bone defects. It functions as a total knee implant intended to provide functional stability for patients undergoing knee revision procedures.

This device is supplied by Medacta International S.A. and has received FDA 510(k) clearance. It is part of the GMK Revision System portfolio, which offers various implant solutions for orthopedic surgical applications.

Other devices from Medacta International S.A.

See all devices from Medacta International S.A. →

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 primary clinical purpose of the GMK Sphere Revision?

    The GMK Sphere Revision is a total knee prosthesis system specifically indicated for use in knee revision procedures. It is designed to assist surgeons in addressing complex clinical challenges such as ligament instability and bone defects to restore functional stability to the joint.

  • Is the GMK Sphere Revision part of a larger product line?

    Yes, this device is a component of the broader GMK Revision System portfolio. This portfolio is managed by Medacta International S.A. and provides a variety of implant solutions tailored for orthopedic surgical applications.

  • What is the regulatory status of the GMK Sphere Revision?

    The GMK Sphere Revision has received FDA 510(k) clearance. This indicates that the device has been reviewed and determined to be substantially equivalent to legally marketed predicate devices under the traditional 510(k) pathway.