Explant Osteonecrosis Intervention Implant Removal System

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K050766 ↗

FDA Product Code

HWE

Device Class

Class I

Regulation

21 CFR Part 878.4820

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• Trabecular Metal Acetabular Revision Shells

  Class II

  FDA 510(k) K050937 Active Cleared 11 May 2005

• Modification to:trabecular Metal Femoral Cone Augments, Models 03-125-Zzzz

  Class II

  FDA 510(k) K051756 Active Cleared 27 Jul 2005

• Trabecular Metal Bone Stabilization Implant, Model 99-11197-XX-10

  Class II

  FDA 510(k) K050101 Active Cleared 15 Apr 2005

• The Trabecular Metal Glenoid - Bigliani/Flatow the Complete Shoulder Solution, Model 4316-Xx-Xx

  Class II

  FDA 510(k) K043061 Active Cleared 23 Nov 2004

• The Zimmer Tmt Trabecular Metal Vertebral Body Replacement System

  Class II

  FDA 510(k) K052950 Active Cleared 16 Nov 2005

• Vista P Vertebral Body Replacement System

  Class II

  FDA 510(k) K061155 Active Cleared 22 Sep 2006

See all devices from Zimmer Trabecular →