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Posterior Stabilised Nuffield Total Knee System

by Corin USA

510(k) K973595

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 NumberK973595 Date19 Dec 1997ClearedStatusActive

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  • Withdrawn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)

Full name
The Posterior Stabilised Nuffield Total Knee System
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, 22 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 Posterior Stabilised Nuffield Total Knee System is a semi-constrained, patellofemorotibial knee prosthesis. This three-part replacement system features cobalt-chrome alloy femoral and tibial components paired with an ultra-high-molecular-weight polyethylene tibial insert.

The system is designed for cemented use only and includes an optional all-polyethylene monoblock tibial component for low-demand patients. This device is authorized under FDA 510(k) number K973595.

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Questions

AI-generated answers, 22 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 components make up the Nuffield Total Knee System?

    This is a three-part replacement system consisting of cobalt-chrome alloy femoral and tibial components paired with an ultra-high-molecular-weight polyethylene tibial insert. The system also offers an optional all-polyethylene monoblock tibial component for patients with lower functional demands.

  • Is the Nuffield Total Knee System intended for cementless fixation?

    No, the Nuffield Total Knee System is designed exclusively for cemented use. This means the components must be secured to the bone using bone cement during the surgical procedure to ensure proper fixation.

  • What is the regulatory status of this knee prosthesis?

    The Posterior Stabilised Nuffield Total Knee System is authorized under FDA 510(k) number K973595. This indicates that the device was found to be substantially equivalent to legally marketed predicate devices.