Tricon Unicompartmental Knee System

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K854325 ↗

FDA Product Code

HSX

Device Class

Class II

Regulation

21 CFR Part 888.3520

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. →

• What is the Tricon Unicompartmental Knee System used for?

  The Tricon Unicompartmental Knee System is a prosthesis designed for unicompartmental knee replacement procedures. It is a non-constrained, cemented, metal/polymer device used for orthopedic applications to replace damaged knee compartments.

• How is the Tricon Unicompartmental Knee System supplied?

  The device is supplied by Richards Medical Co., Inc. It is a single-use device that comes in various sizes and models to accommodate different patient anatomies. The specific configurations and packaging details would be provided by the manufacturer.

• What is the regulatory status of the Tricon Unicompartmental Knee System?

  The Tricon Unicompartmental Knee System has FDA 510(k) clearance with number K854325. It was determined to be substantially equivalent on December 9, 1985, and is classified under product code HSX. This clearance indicates it meets the FDA's requirements for safety and effectiveness.

• Is the Tricon Unicompartmental Knee System sterile?

  The device is supplied in a sterile condition for single-use only. It should be handled according to sterile technique during implantation to prevent infection. The sterilization method and expiration date would be specified by the manufacturer.