Charnley Femoral Component

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K760974 ↗

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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  FDA 510(k) K021653 Active Cleared 29 Jul 2002

• Codman* External Drainage System II (Eds-II)

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  FDA 510(k) K902257 Active Cleared 19 Jul 1990

• Orbit Galaxy G2 Microcoil Delivery System

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• Vanderbilt Pituitary Retractor

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  FDA 510(k) K761096 Active Cleared 30 Nov 1976

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  FDA 510(k) K083895 Active Cleared 23 Jun 2009

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  FDA 510(k) K904120 Active Cleared 9 Oct 1990

See all devices from Codman & Shurtleff, Inc. →

• 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.