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Nuffield Total Knee System

by Corin USA

510(k) K980545

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 NumberK980545 Date29 Apr 1998ClearedStatusActive

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  • Withdrawn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 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, 1 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 Nuffield Total Knee System is a total knee prosthesis classified as a Total Knee Prosthesis (FDA Product Code: JWH). It comprises cobalt-chrome alloy femoral, tibial, and patellar components engineered for primary or revision knee arthroplasty. The system incorporates a plasma-sprayed coating to enhance surface roughness, improving mechanical fixation with PMMA bone cement. Its design aims to restore joint function and stability in patients with degenerative or traumatic knee damage.

The device is supplied as a modular system for surgical use in orthopedic settings, requiring aseptic preparation and sterile handling. Components are intended for single-use and are not designed for reuse. No MRI safety information is specified, and the system is cleared under FDA 510(k) K980545 as substantially equivalent to a predecessor device. Storage and handling must comply with orthopedic implant protocols to maintain sterility and integrity.

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Questions

AI-generated answers, 1 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 Nuffield Total Knee System used for?

    The Nuffield Total Knee System is designed for primary or revision knee arthroplasty in patients with degenerative or traumatic knee damage. Its cobalt-chrome alloy components restore joint function and stability, while the plasma-sprayed coating improves mechanical fixation when used with PMMA bone cement.

  • How is the Nuffield Total Knee System supplied and prepared for surgery?

    The system is supplied as a modular orthopedic implant kit, intended exclusively for surgical use in sterile environments. Components must undergo aseptic preparation prior to use, adhering to standard orthopedic implant protocols to preserve sterility and integrity.

  • Are the components of the Nuffield Total Knee System reusable?

    No, the components of the Nuffield Total Knee System are explicitly intended for single-use only. They are not designed or cleared for reuse, which aligns with standard orthopedic implant practices to prevent infection and ensure reliability.

  • What materials are used in the Nuffield Total Knee System?

    The system consists of cobalt-chrome alloy components for the femoral, tibial, and patellar parts. The cobalt-chrome alloy provides durability and biocompatibility, while the plasma-sprayed coating enhances surface roughness for improved cement fixation.

  • How should the Nuffield Total Knee System be stored?

    Storage must comply with orthopedic implant protocols to maintain sterility and component integrity. The system should be kept in its original packaging, protected from moisture, contamination, and physical damage until immediate preoperative use.