Uc-Plus Solution Unicondylar Knee

• • Terminated Z-0192-2007 FDA Unclassified (pre-2012) ·initiated 18 Jul 2006

  The modified devices were distributed by Plus Orthopedics USA (Plus USA) June 10, 2003 prior to FDA approval to market of the modified device (Special 510(k) K032052, clearance date July 25, 2003) and withdrawn from the field June 25, 2003.

510(k) Number

K032052 ↗

FDA Product Code

HRY

Device Class

Class II

Regulation

21 CFR Part 888.3530

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• Rt-Plus Modular Cemented Knee Components

  Class II

  FDA 510(k) K003504 Active Cleared 11 May 2001

• Plus Bipolar Prosthesis Cocrmo

  Class II

  FDA 510(k) K982447 Active Cleared 25 Nov 1998

• Tc-Plus Porous Tibial Components

  Class II

  FDA 510(k) K011288 Active Cleared 24 May 2001

• Modification to Slim Gliding Nail System

  Class II

  FDA 510(k) K033763 Active Cleared 18 Dec 2003

• Pe-Plus Acetabular Cup

  Class II

  FDA 510(k) K992153 Active Cleared 23 Sep 1999

• Rt-Plus Knee Additional Components

  Class II

  FDA 510(k) K013340 Active Cleared 20 Dec 2001

See all devices from Plus Orthopedics →