UC-PLUS Solution Unicondylar Knee System

• • Terminated Z-0191-2007 FDA Unclassified (pre-2012) ·initiated 18 Jul 2006

  There exists the possibility that incomplete bony support or insufficient cementing of the implanted device can result in fatigue fracture of the UC-PLUS Solution Femoral Component.

510(k) Number

K982859 ↗

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

• Uc-Plus Solution Unicondylar Knee

  Class II

  FDA 510(k) K032052 Active Cleared 25 Jul 2003

• Pe-Plus Acetabular Cup

  Class II

  FDA 510(k) K992153 Active Cleared 23 Sep 1999

See all devices from Plus Orthopedics →

• What types of knee damage is the UC-PLUS Solution Unicondylar Knee System designed to address in patients?

  The UC-PLUS Solution Unicondylar Knee System is specifically designed for partial knee arthroplasty to replace damaged unicompartmental knee joints. It is intended for patients with localized degenerative joint disease or trauma-related cartilage and bone lesions, restoring function and mobility in affected areas.

• Is the UC-PLUS Solution Unicondylar Knee System intended for reuse in surgical settings, or is it single-use only?

  The UC-PLUS Solution Unicondylar Knee System is explicitly intended for single-use in an orthopedic surgical setting, as stated in its description. This ensures patient safety and sterility standards are maintained.

• How is the UC-PLUS Solution Unicondylar Knee System secured in place during surgery, and what materials are used?

  The system is cemented into place during surgery, meaning bone cement is used to secure the metal/polymer prosthesis to the patient’s existing bone. This method provides stability for the replacement joint.

• Does the UC-PLUS Solution Unicondylar Knee System come in multiple sizes to accommodate different patients?

  Yes, the UC-PLUS Solution Unicondylar Knee System offers multiple component sizes to match varying anatomical requirements. The listed FEI numbers (e.g., 3005706667) correspond to specific implant configurations available for customization during surgery.

• What regulatory pathway was followed for FDA clearance of the UC-PLUS Solution Unicondylar Knee System, and what does that mean for its use?

  The UC-PLUS Solution Unicondylar Knee System received FDA 510(k) clearance under the Traditional pathway, meaning it was determined to be substantially equivalent to a legally marketed device already on the market. This clearance confirms its compliance with FDA standards for safety and effectiveness as a Class II medical device.