P.F.C.(Tm) Unicondylar Knee Syst, Por Coat Femoral

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

510(k) Number

K914439 ↗

FDA Product Code

HSX

Device Class

Class II

Regulation

21 CFR Part 888.3520

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• P.F.C. Hip System Non-Porous Acetabular Component

  Class II

  FDA 510(k) K902137 Active Cleared 26 Jun 1990

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

  Class II

  FDA 510(k) K935452 Active Cleared 6 Oct 1994

• Ultima Unipolar Modular Head

  Class II

  FDA 510(k) K940190 Active Cleared 29 Sep 1994

• Inset Patellar Component

  Class II

  FDA 510(k) K904300 Active Cleared 17 Oct 1990

• Gross Hip Femoral Component

  Class II

  FDA 510(k) K904737 Active Cleared 26 Jul 1991

• Ultima All Uhmwpe Cemented Acetabular Cups

  Class II

  FDA 510(k) K924115 Active Cleared 24 Nov 1992

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

• What is the primary function of the P.F.C. Unicondylar Knee System?

  This device is a femorotibial, non-constrained, cemented metal knee prosthesis designed specifically to replace the articulating surfaces of the knee joint.

• How is the P.F.C. Unicondylar Knee System secured during implantation?

  The system is designed as a cemented prosthesis, meaning it requires the use of bone cement to fix the metal components to the bone during the surgical procedure.

• What is the regulatory status of this knee prosthesis?

  The P.F.C. Unicondylar Knee System, Porous Coated Femoral, is authorized under FDA 510(k) number K914439, having been determined to be substantially equivalent to existing devices.