P.F.C. 2 Total Hip System Porous Coated Modular Femoral Component

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K945518 ↗

FDA Product Code

KWY

Device Class

Class II

Regulation

21 CFR Part 888.3390

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

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  Class II

  FDA 510(k) K954481 Active Cleared 10 Oct 1996

• J & J Cardiovascular Maxima Hollow Fiber Oxygenato

  Class II

  FDA 510(k) K853251 Active Cleared 16 Oct 1985

• Darwin Knee System (TC3)

  Class II

  FDA 510(k) K952830 Active Cleared 18 Jan 1996

• Adaptalite* Porcelain Veneer Cementation System

  Class II

  FDA 510(k) K871295 Active Cleared 29 May 1987

• Coman(R) Cu-11 Model Number 82-6634

  Class II

  FDA 510(k) K945585 Active Cleared 26 Oct 1995

• Fotofill Activator Light

  Class II

  FDA 510(k) K772278 Active Cleared 3 Jan 1978

See all devices from Johnson & Johnson Professionals, Inc. →

• What is the P.F.C. 2 Porous Coated Modular Femoral Component used for?

  This device is designed specifically for total and partial hip arthroplasty procedures. Its porous-coated surface is engineered to improve osseointegration with the femur, ensuring stability and long-term fixation. This is particularly useful for patients suffering from degenerative hip conditions that require surgical intervention to restore joint function and alleviate pain.

• How is the P.F.C. 2 Porous Coated Modular Femoral Component supplied?

  The device is supplied as a sterile, single-use implant. It is intended exclusively for surgical use in orthopaedic procedures and must be handled according to sterile surgical protocols to preserve its integrity before implantation. The modular design allows for intraoperative adjustments to optimize alignment and fit during surgery.

• Is the P.F.C. 2 Porous Coated Modular Femoral Component reusable?

  No, this device is intended for single-use only. Its sterile packaging and design ensure safety and efficacy for one surgical procedure. Reuse is not recommended or supported by the manufacturer, as it could compromise sterility and compromise patient safety.

• What regulatory approval does the P.F.C. 2 Porous Coated Modular Femoral Component hold?

  The device holds FDA 510(k) clearance under the reference number K945518. This clearance indicates that it has been determined to be substantially equivalent to a legally marketed device in terms of safety and effectiveness. The device falls under the Orthopaedic Devices category and is regulated accordingly.

• How should the P.F.C. 2 Porous Coated Modular Femoral Component be stored?

  The device must be stored in accordance with sterile surgical protocols to maintain its integrity prior to implantation. This includes keeping it in its original, unopened packaging and ensuring it is protected from contamination, moisture, and physical damage. Always follow the manufacturer’s storage guidelines to preserve sterility and functionality.