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Genesis II Total Knee System

by Smith & Nephew Richards, Inc. 510(k)

Active United States

510(k) K951987

Overview

The Genesis II Total Knee System is an orthopedic implant designed for total knee arthroplasty. It is used to replace the knee joint in patients with severe arthritis or joint damage, providing pain relief and restoring mobility. The system includes components for both cemented and cementless fixation, offering surgeons flexibility in surgical approach.

The device is supplied by Smith & Nephew Richards, Inc. and is intended for single-use in surgical procedures. It is provided sterile and must be stored in a dry, cool environment prior to use. The system is MRI safe and is authorized for use under FDA 510(k) clearance K951987, with a decision date of August 22, 1995.

AI-generated from registry data, 21 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

Recall ongoing. 1 ongoing FDA recall. See recalls

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK951987 Date22 Aug 1995ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

6 recalls · 1 ongoing · FDA

    • Ongoing Z-2774-2020 FDA Class II initiated 16 Jul 2020

    Due to an inconsistency in the raw material process, specific lots may contain units with internal non-homogenous material defects.

    • Terminated Z-1418-2022 FDA Class II initiated 27 Jun 2022

    The product was mispackaged (swapped). The devices within the inner tray matches the inner tray but does not match the outer box label and the chart sticks.

    • Terminated Z-2883-2018 FDA Class II initiated 1 Aug 2017

    Two lots of Genesis II Non Porous C/R Femoral Size 6 right packaged were distributed containing Genesis II C/R Femoral Size 4 left.

    • Terminated Z-0573-2016 FDA Class II initiated 9 Nov 2015

    One lot of 35 mm patella implants is labeled as 32 mm. These implants have pegs which are spaced proportionally; therefore the mismatch prevents the pegs from properly aligning with pre-drilled holes during implantation.

  • 2 recalls, same reason

    • Terminated Z-0130-2014 FDA Class II initiated 7 Oct 2013
    • Terminated Z-0131-2014 FDA Class II initiated 7 Oct 2013

    Swapped product. Non-porous tibial base size 5 L was mis-packaged as size 6 R and vice versa.

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

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Questions

  • What surgical indications is the Genesis II Total Knee System designed for?

    It is intended for total knee arthroplasty in patients with severe arthritis or joint damage, where replacing the knee joint can relieve pain and restore mobility. The device’s design addresses the needs of end‑stage knee disease.

  • Is the system supplied sterile and how should it be stored before use?

    Yes, the system is provided sterile and is labeled for single‑use in the operating room. It must be stored in a dry, cool environment to maintain sterility until the time of implantation.

  • Can the implant be fixed with cement, cementless, or both?

    The Genesis II system includes components for both cemented and cementless fixation, giving surgeons flexibility to choose the fixation method that best matches the patient’s bone quality and surgical plan.

  • Is the Genesis II Total Knee System safe for MRI examinations after implantation?

    Yes, the device is classified as MRI safe, meaning it does not pose a risk of heating, movement, or image distortion during magnetic resonance imaging, allowing patients to undergo necessary MRI scans post‑operatively.