P.F.C. Uni-Compartmental Knee System

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K954481 ↗

FDA Product Code

HRY

Device Class

Class II

Regulation

21 CFR Part 888.3530

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

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  FDA 510(k) K952830 Active Cleared 18 Jan 1996

• Adaptalite* Porcelain Veneer Cementation System

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  FDA 510(k) K871295 Active Cleared 29 May 1987

• Coman(R) Cu-11 Model Number 82-6634

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• Fotofill Activator Light

  Class II

  FDA 510(k) K772278 Active Cleared 3 Jan 1978

• Porous Coated Hip Femoral Prosthesis

  Class II

  FDA 510(k) K862326 Active Cleared 16 Jul 1986

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