Whiteside Ortholoc Modular Metal-Backed Patella

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K896081 ↗

FDA Product Code

JWH

Device Class

Class II

Regulation

21 CFR Part 888.3560

Advisory Committee

Orthopedic

FDA Decision

SN

• 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 types of knee surgeries is the Whiteside Ortholoc Modular Metal-Backed Patella designed for, and how does its modularity benefit patients?

  The Whiteside Ortholoc Modular Metal-Backed Patella is specifically designed for partial knee replacement surgeries, focusing on restoring function and stability to the patellofemoral joint. Its modular metal-backed design allows for customization to match individual patient anatomy, ensuring a better fit and potentially improving outcomes by addressing specific anatomical variations during surgery.

• Is this device intended for reuse, or is it meant to be used only once per patient? How does this affect its use in the operating room?

  The Whiteside Ortholoc Modular Metal-Backed Patella is explicitly intended for single-use in sterile conditions. This means each implant is meant to be used on one patient only, which helps minimize infection risks and ensures compliance with sterile surgical protocols. Clinicians should follow standard single-use orthopedic implant handling procedures during surgery.

• How is the Whiteside Ortholoc Modular Metal-Backed Patella supplied, and what preparation is required before use in surgery?

  The device is supplied as a cemented implant, meaning it is intended to be fixed in place using bone cement during surgery. Before use, the implant must be sterilized and prepared according to the manufacturer’s instructions, ensuring it remains sterile until implanted. The modular components should be assembled as needed to match the patient’s anatomy, following the included surgical guidelines.

• What storage conditions should be followed for the Whiteside Ortholoc Modular Metal-Backed Patella to maintain its integrity before use?

  While specific storage instructions aren’t detailed in the provided data, as a sterile, single-use orthopedic implant, it should be stored in a clean, dry environment protected from moisture, contamination, and physical damage. The packaging should remain intact until immediately before use to preserve sterility and functionality. Always refer to the manufacturer’s packaging labels for precise storage recommendations.

• What does the FDA clearance for this device indicate about its intended use, and how does that differ from other knee prostheses?

  The FDA clearance (K896081) under product code JWH indicates that the Whiteside Ortholoc Modular Metal-Backed Patella was deemed substantially equivalent to a legally marketed device for partial knee replacement, specifically targeting the patellofemoral joint. Unlike total knee replacements, this device is not intended for full knee arthroplasty but rather for targeted restoration of the patella-to-femur interface, offering a semi-constrained design for stability in partial procedures.