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Genesis Ii Constrained System

by Smith & Nephew Richards, Inc.

510(k) K962137

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 NumberK962137 Date2 Aug 1996ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-0118-2021 FDA Class II initiated 21 Sep 2020

    The anterior locking detail does not meet its design specifications.

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  • Withdrawn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 Genesis Ii Constrained System is an orthopedic device, specifically a total knee system. It is designed to offer solutions to address intraoperative situations and provide accurate and reproducible knee alignment. The system includes instrumentation to assist the surgeon in obtaining accurate results.

The Genesis Ii Constrained System is supplied by Smith & Nephew Richards, Inc. and has been assigned the product code JWH. It has been cleared by the FDA with the k number K962137. The device is intended for use in orthopedic procedures, and its safety and effectiveness have been summarized in a PDF document.

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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 Genesis II Constrained System used for?

    The Genesis II Constrained System is used in orthopedic procedures to address intraoperative situations and provide accurate and reproducible knee alignment.

  • How is the Genesis II Constrained System supplied?

    The Genesis II Constrained System is supplied by Smith & Nephew Richards, Inc.

  • What is the regulatory status of the Genesis II Constrained System?

    The Genesis II Constrained System has been cleared by the FDA with the k number K962137, and is considered substantially equivalent.