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Charnley Femoral Component

by Codman & Shurtleff, Inc. 510(k)

Active United States

510(k) K760974

Overview

The Charnley Femoral Component is a cemented, metal hip prosthesis designed for use in total hip arthroplasty. It is intended to replace the femoral head and neck, providing stability and restoring function to the hip joint by articulating with a femoral acetabular component.

This device is supplied as a reusable surgical implant and is classified under FDA product code JDG as a Class II medical device under special controls. It was granted FDA 510(k) clearance (K760974) in 1976 under regulation 888.3360, with a decision of Substantially Equivalent (SESE). Multiple registration numbers and FEI numbers are associated with its variants, reflecting its regulatory filing history.

AI-generated from registry data, 19 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK760974 Date16 Nov 1976ClearedStatusActive

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

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
JDG
Device Class
Class II
Regulation
21 CFR Part 888.3360
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

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Questions

  • What is the Charnley Femoral Component used for in total hip arthroplasty procedures?

    The Charnley Femoral Component is designed to replace the femoral head and neck during total hip arthroplasty, providing stability and restoring function to the hip joint. It is cemented in place and articulates with a femoral acetabular component to mimic the natural movement of the hip.

  • Is the Charnley Femoral Component intended for single-use or can it be reused in multiple surgeries?

    The Charnley Femoral Component is explicitly described as a reusable surgical implant. It is not intended for single-use, but rather for repeated use in multiple procedures, adhering to proper sterilization and handling protocols.

  • What regulatory pathway was followed for FDA clearance of this device, and when was it approved?

    The Charnley Femoral Component received FDA 510(k) clearance under the traditional review pathway in 1976 (K760974). It was classified as Substantially Equivalent (SESE) to a predicate device and falls under FDA product code JDG, categorized as a Class II orthopedic implant.

  • Does the Charnley Femoral Component come in multiple sizes or models, and how are they differentiated?

    While the provided data does not specify exact sizes or model variations in detail, the device has multiple FEI (Firm Establishment Identification) numbers and registration numbers listed, indicating it exists in several variants. These likely correspond to different femoral sizes or designs to accommodate varying patient anatomies. For precise sizing, refer to the manufacturer’s catalog or surgical guides.