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Cofield Total Shoulder System

by Smith & Nephew, Inc. 510(k)

Active United States

510(k) K070565

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Abbreviated NumberK070565 Date18 May 2007ClearedStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
MBF
Device Class
Class II
Regulation
21 CFR Part 888.3670
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 Cofield Total Shoulder System is a semi‑constrained shoulder prosthesis composed of metal and polymer components and designed for uncemented implantation. It is classified as a prosthesis, shoulder, semi‑constrained, metal/polymer, uncemented device.

The system is supplied by Smith & Nephew, Inc. and was cleared through an FDA 510(k) submission (K070565) as a Class II device under 21 CFR 888.3670. It is a modular shoulder arthroplasty system that includes multiple stem lengths and is intended for use in orthopedic shoulder reconstruction. The device is regulated as a medical device in the United States and is identified by the product code MBF.

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