Whiteside EPS Femoral Hip Prosthesis

No FDA recalls found in the data synced 6 Oct 2026.

Full name

Whiteside Eps(Tm) Femoral Hip Prosthesis

Generic Name

PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

PMA Number

P880076 ↗

FDA Product Code

LPH

Device Class

Class II

Regulation

21 CFR Part 888.3358

Advisory Committee

Orthopedic

FDA Decision

APPR Approved

PMA Supplement

S001 (Normal 180 Day Track)

• Silastic Soft Sheeting

  Unclassified

  FDA 510(k) K894226 Active Cleared 3 Jan 1990

• Nexus(Tm) Femoral Hip Stem

  Class II

  FDA 510(k) K911052 Active Cleared 17 Jun 1991

• Ortholoc Advantim Revision Femoral Component

  Class II

  FDA 510(k) K932210 Active Cleared 7 Sep 1994

• Ortholoc(R) Advantim(Tm) Femoral Component

  Class II

  FDA 510(k) K930188 Active Cleared 3 Aug 1993

• Lacey Posterior Stabilized Knee System

  Class II

  FDA 510(k) K884338 Active Cleared 1 Feb 1989

• Trac-Wright System, Model TW2

  Class II

  FDA 510(k) K910594 Active Cleared 23 Sep 1991

See all devices from Dow Corning Wright →

• What type of hip replacement surgery is the Whiteside EPS™ Femoral Hip Prosthesis designed for, and why is the porous surface important?

  The Whiteside EPS™ Femoral Hip Prosthesis is designed for total hip arthroplasty procedures, specifically replacing the femoral head and neck. The porous surface is engineered to integrate with the patient’s bone through a process called osseointegration, which promotes long-term stability without requiring bone cement. This feature reduces the risk of loosening over time, enhancing durability and reducing revision surgery needs.

• Is the Whiteside EPS™ Femoral Hip Prosthesis reusable or single-use, and how should it be handled during surgery?

  The Whiteside EPS™ Femoral Hip Prosthesis is a sterile, single-use device. It must be handled under aseptic conditions to prevent contamination, as reusing it could compromise patient safety and sterility. Proper sterile packaging and implantation techniques are critical to maintaining its integrity and effectiveness.

• What materials are used in the Whiteside EPS™ Femoral Hip Prosthesis, and how does the semi-constrained design benefit patients?

  The device is composed of metal and polymer components, combining durability with biocompatibility. The semi-constrained design allows for some flexibility in movement while maintaining stability, which can reduce stress on the surrounding tissues and improve joint function compared to fully constrained implants.

• How is the regulatory approval status of the Whiteside EPS™ Femoral Hip Prosthesis determined, and what does this mean for clinicians?

  The device holds FDA Premarket Approval (PMA) under PMA number P880076, including a supplement (S001) for design or component changes. This means the device has undergone rigorous clinical evaluation to ensure safety and effectiveness for its intended use in total hip arthroplasty. Clinicians can rely on this approval as evidence of the device’s compliance with regulatory standards before implementation.