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GMK Revision & Hinge Extension - TiNbN Coating

by Medacta International S.A.

510(k) K210010

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 NumberK210010 Date2 Mar 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  • Withdrawn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
KRO
Device Class
Class II
Regulation
21 CFR Part 888.3510
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 27 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 Revision & Hinge Extension - TiNbN Coating is a knee prosthesis implant system designed for revision procedures. It is a constrained, cemented metal/polymer femorotibial prosthesis that addresses ligament instability and bone defects during knee revision surgery.

The device is supplied as part of a modular system with instrument solutions and is intended for single use. It is manufactured by Medacta International S.A. and has received FDA 510(k) clearance with the product code KRO, classified under regulation number 888.3510.

Other devices from Medacta International S.A.

See all devices from Medacta International S.A. →

Questions

AI-generated answers, 27 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 GMK Revision & Hinge Extension - TiNbN Coating used for?

    The GMK Revision & Hinge Extension - TiNbN Coating is a knee prosthesis implant system designed specifically for revision procedures. It addresses ligament instability and bone defects during knee revision surgery as a constrained, cemented metal/polymer femorotibial prosthesis.

  • How is the GMK Revision & Hinge Extension - TiNbN Coating supplied?

    The device is supplied as part of a modular system with instrument solutions. It is intended for single use and is manufactured by Medacta International S.A.

  • What is the regulatory status of the GMK Revision & Hinge Extension - TiNbN Coating?

    The GMK Revision & Hinge Extension - TiNbN Coating has received FDA 510(k) clearance with the product code KRO, classified under regulation number 888.3510. It is classified as a Class II device and has been determined to be substantially equivalent.

  • Is the GMK Revision & Hinge Extension - TiNbN Coating sterile?

    The device is supplied as part of a modular system with instrument solutions and is intended for single use. However, the description does not explicitly state whether the device is supplied sterile.