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Evolis Total Knee System

by Medacta International S.A.

510(k) K081023

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 · Traditional NumberK081023 Date22 Oct 2008ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-2095-2010 FDA Unclassified (pre-2012) initiated 11 Sep 2009

    Medacta USA Inc is initiating a recall on the Femoral Sizer, an orthopedic manual surgical instrument, because the "L" and "R" markings are mislabeled which would cause incorrect usage.

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  • Withdrawn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, 24 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 Evolis Total Knee System is a knee prosthesis designed for cemented use in total knee arthroplasty, intended for cases where there is evidence of sufficient sound bone to seat and support the implant. This system is part of Medacta's Total Knee portfolio and features different implant options for Kinematic Alignment.

The system includes the GMK Sphere (Medial Ball-in-Socket Knee) and GMK SpheriKA (the first KA-optimized implant). It is supplied as a single-use device and has received FDA 510(k) clearance (K081023) as substantially equivalent, reviewed by the Orthopedic advisory committee. The device is available in various sizes and is designed for use in total knee arthroplasty procedures.

Other devices from Medacta International S.A.

See all devices from Medacta International S.A. →

Questions

AI-generated answers, 24 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 Evolis Total Knee System used for?

    The Evolis Total Knee System is a knee prosthesis designed for cemented use in total knee arthroplasty, intended for cases where there is evidence of sufficient sound bone to seat and support the implant.

  • What components are included in the Evolis Total Knee System?

    The system includes the GMK Sphere (Medial Ball-in-Socket Knee) and GMK SpheriKA (the first KA-optimized implant), offering different implant options for Kinematic Alignment within Medacta's Total Knee portfolio.

  • Is the Evolis Total Knee System single-use or reusable?

    The Evolis Total Knee System is supplied as a single-use device, meaning it should be used for one patient only and then discarded according to medical waste disposal protocols.

  • What regulatory clearance has the Evolis Total Knee System received?

    The Evolis Total Knee System has received FDA 510(k) clearance (K081023) as substantially equivalent, reviewed by the Orthopedic advisory committee, indicating it meets the FDA's criteria for safety and effectiveness.

  • What sizes are available for the Evolis Total Knee System?

    The Evolis Total Knee System is available in various sizes to accommodate different patient anatomies, though specific size ranges are not detailed in the provided information.