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Gmk Sphere

by Medacta International

510(k) K121416

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 NumberK121416 Date20 Jul 2012ClearedStatusActive

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  • Withdrawn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, 6 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 GMK Sphere is a total knee implant designed to provide functional stability and support during activities of daily living. This medial ball-in-socket knee system is engineered based on knee anatomy and kinematic studies to assist in patient satisfaction and the reduction of post-operative pain.

The system is available as a cemented tibial baseplate constructed from Co28-Cr6-Mo with a TiNbN coating and UHMWPE. This device has received FDA 510k clearance under the traditional pathway.

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Questions

AI-generated answers, 6 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 purpose of the GMK Sphere knee implant?

    The GMK Sphere is a total knee implant system designed to provide functional stability and support during daily activities. It utilizes a medial ball-in-socket design based on anatomical and kinematic studies to help reduce post-operative pain and improve patient satisfaction.

  • What materials are used in the construction of the GMK Sphere?

    The system features a cemented tibial baseplate. The materials used in its construction include a Co28-Cr6-Mo alloy with a TiNbN coating, paired with UHMWPE components.

  • What is the regulatory status of the GMK Sphere?

    The GMK Sphere has received FDA 510k clearance under the traditional pathway, identified by the k-number K121416.