Modification to Surgical Titanium Mesh System

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K020522 ↗

FDA Product Code

MQP

Device Class

Class II

Regulation

21 CFR Part 888.3060

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• Moss Miami Spinal Systems

  Class II

  FDA 510(k) K013296 Active Cleared 9 Oct 2001

• Monarch Spine System

  Class II

  FDA 510(k) K021335 Active Cleared 11 Jul 2002

• Eagle Anterior Cervial Plate System

  Class II

  FDA 510(k) K040197 Active Cleared 2 Apr 2004

• Stackable Cage System

  Class II

  FDA 510(k) K001340 Active Cleared 26 Jul 2000

• Depuy Acromed Vbr System

  Class II

  FDA 510(k) K030833 Active Cleared 10 Apr 2003

• Crossover Cross Connector (Moss Miami Spine System)

  Class II

  FDA 510(k) K021880 Active Cleared 26 Jun 2002

See all devices from Depuyacromed →

• What is the Modification to Surgical Titanium Mesh System used for?

  It is intended for use with supplemental internal fixation systems in spinal procedures as a Spinal Vertebral Body Replacement Device under product code MQP, providing structural support during spinal fusion or reconstruction when combined with compatible titanium plate or rod systems.

• How is the Modification to Surgical Titanium Mesh System supplied and what is its regulatory classification?

  It is supplied as a Class II medical device with special controls, cleared via FDA 510(k) submission K020522 on March 21, 2002, and is substantially equivalent to a predicate device, meaning it meets safety and effectiveness requirements for its intended spinal use without requiring premarket approval.

• Which DePuy AcroMed systems is this titanium mesh modification compatible with?

  It is designed to be used in conjunction with DePuy AcroMed titanium plate or rod systems, including models such as Kaneda SR, University Plate, M-2, ISOLA, VSP, Moss Miami, TiMX, and Profile, allowing surgeons to integrate the mesh into existing fixation constructs for spinal stabilization.