Proven Revision Modular Tibial Tray

• 5 recalls, same reason

  • Terminated Z-0481-2008 FDA Unclassified (pre-2012) ·initiated 5 Oct 2007
  • Terminated Z-0482-2008 FDA Unclassified (pre-2012) ·initiated 5 Oct 2007
  • Terminated Z-0480-2008 FDA Unclassified (pre-2012) ·initiated 5 Oct 2007
  • Terminated Z-0479-2008 FDA Unclassified (pre-2012) ·initiated 5 Oct 2007
  • Terminated Z-0483-2008 FDA Unclassified (pre-2012) ·initiated 5 Oct 2007

  The screws may fracture

510(k) Number

K051976 ↗

FDA Product Code

JWH

Device Class

Class II

Regulation

21 CFR Part 888.3560

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• GENFlex2 Total Knee System - Ultra-Congruent CR Tibial Insert

  Class II

  FDA 510(k) K173875 Active Cleared 19 Jan 2018

• Protract Press Fit Hip Stem

  Class II

  FDA 510(k) K003447 Active Cleared 15 Dec 2000

• Proform Cemented Femoral Component

  Class II

  FDA 510(k) K951083 Active Cleared 22 May 1995

• Dual Taper Wedge Pressed Fit Femoral Component

  Class II

  FDA 510(k) K953268 Active Cleared 17 Jan 1996

• Proven Knee System

  Class II

  FDA 510(k) K000113 Active Cleared 4 Apr 2000

• Stelkast Bipolar System

  Class II

  FDA 510(k) K972961 Active Cleared 4 Nov 1997

See all devices from Stelkast Company →

• What types of knee surgeries is the Proven Revision Modular Tibial Tray specifically designed for, and why is modularity important in these cases?

  The Proven Revision Modular Tibial Tray is designed for total knee replacement revision procedures, where bone stock and soft tissue integrity are sufficient for cemented fixation. Modularity is important because it allows surgeons to customize the tray’s size and shape to match the patient’s unique anatomy, improving fit and stability during revision surgeries where anatomy may differ from primary arthroplasty cases.

• Is this tibial tray reusable, or is it intended for single-use only? How does this affect its clinical use?

  The Proven Revision Modular Tibial Tray is intended for single-use only, as implied by its classification as a semi-constrained, cemented knee prosthesis for revision arthroplasty. Single-use ensures sterility and reduces infection risks, which is critical in revision surgeries where prior procedures may have introduced contaminants or compromised tissue integrity.

• What are the key differences between this tibial tray and a standard total knee prosthesis, particularly in terms of articulation and fixation?

  Unlike standard total knee prostheses, the Proven Revision Modular Tibial Tray is semi-constrained and designed specifically for patellofemorotibial articulation, offering enhanced stability for revision cases. It also relies on cemented fixation, which provides stronger initial stability compared to press-fit designs, making it suitable for patients with compromised bone quality or previous surgeries where bone stock may be limited.

• How should the Proven Revision Modular Tibial Tray be stored to maintain its integrity before use?

  While specific storage instructions aren’t detailed in the data, standard practice for modular knee implants like this typically requires sterile packaging and storage in a clean, dry environment away from direct sunlight or extreme temperatures. Since it’s intended for single-use, it should remain unopened until immediately before surgery to preserve sterility and prevent contamination.