Profile Femoral Hip Prosthesis

No FDA recalls on record, checked 22 Oct 2026.

Full name

Profile Femoral Hip

510(k) Number

K850055 ↗

FDA Product Code

KWA

Device Class

Class III

Regulation

21 CFR Part 888.3330

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• Delta Shoulder

  Class II

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• Synatomic Revision Femoral Prosthesis

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• Porocoat (R) Proximal Femoral Third Prosthesis

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• Cobalt Chrome Gemini

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• Depuy Titanium Cross Pin Fixation System

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  FDA 510(k) K954630 Active Cleared 13 Dec 1995

• Depuy Cannulated Cross Pin Screw System

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  FDA 510(k) K963973 Active Cleared 16 Dec 1996

See all devices from Depuy, Inc. →

• What types of hip conditions is the Profile Femoral Hip Prosthesis designed to address in patients?

  The Profile Femoral Hip Prosthesis is specifically designed for hip replacement surgery to restore function and stability in patients suffering from degenerative joint disease or trauma. As a semi-constrained, uncemented acetabular component, it is intended for cases where the natural hip joint has deteriorated or been damaged, requiring a durable metal prosthesis to improve mobility and alleviate pain.

• Is the Profile Femoral Hip Prosthesis reusable or intended for single-use, and how is it supplied?

  The Profile Femoral Hip Prosthesis is intended for single-use only in orthopedic surgical settings. It is supplied sterile, ensuring it meets surgical standards without requiring additional sterilization before use.

• How many variants or sizes of the Profile Femoral Hip Prosthesis are available, and how are they identified?

  The Profile Femoral Hip Prosthesis comes in multiple variants, each identified by unique FEI numbers (e.g., 3020282716, 1047843, etc.). These variants likely correspond to different sizes or configurations to accommodate varying patient anatomies, though exact dimensions or sizing details are not specified in the data.

• What regulatory pathway was followed for FDA clearance of the Profile Femoral Hip Prosthesis, and what class does it belong to?

  The Profile Femoral Hip Prosthesis received FDA 510(k) clearance under the traditional review pathway, with the clearance number K850055. It is classified as a Class III medical device, indicating it carries higher regulatory scrutiny due to its role in restoring critical joint function and potential risks.

• Can the Profile Femoral Hip Prosthesis be used in patients who require MRI scans after surgery, or is there any MRI safety information available?

  The provided data does not include any MRI safety information for the Profile Femoral Hip Prosthesis. Patients should consult their surgeon or the manufacturer for guidance on MRI compatibility, as metal prostheses may pose risks in magnetic fields.