Bio-Fit Hip System

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K854791 ↗

FDA Product Code

KWL

Device Class

Class II

Regulation

21 CFR Part 888.3360

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• Richards Intra-Articular Shaver Motor

  Class I

  FDA 510(k) K842475 Active Cleared 17 Sep 1984

• Hip Continuous Passive Motion Machine

  Class I

  FDA 510(k) K862314 Active Cleared 15 Jul 1986

• U-Impulse Air Conduction in-the-Canal Hearing Aid

  Class I

  FDA 510(k) K873560 Active Cleared 29 Sep 1987

• Omni Itc Type Hearing Aid Model U-Impulse Sp

  Class I

  FDA 510(k) K880286 Active Cleared 23 Feb 1988

• Tricon-M Total Knee System

  Class II

  FDA 510(k) K884824 Active Cleared 21 Nov 1989

• Orthopaedic Cable System

  Class II

  FDA 510(k) K842977 Active Cleared 26 Oct 1984

See all devices from Richards Medical Co., Inc. →