Lanx Fusion System

• • Terminated Z-0220-2015 FDA Class II ·initiated 9 Mar 2011 ·on shared 510(k) K102738

  Biomet Spine, LLC. announces voluntary recall of Durango Anchored ALIF Plate due to the set screw component potentially becoming dislodged from the plate assembly.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K102738 ↗

FDA Product Code

OVD

Device Class

Class II

Regulation

21 CFR Part 888.3080

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• Lanx Spinal Fixation System

  Class II

  FDA 510(k) K043484 Active Cleared 16 May 2005

• Modification to Lanx Posterior Cervicothoracic Spinal Fixation System

  Class II

  FDA 510(k) K100888 Active Cleared 15 Nov 2010

• Lanx Cervical Intervertebral Body Fusion System

  Class II

  FDA 510(k) K103660 Active Cleared 28 Feb 2011

• Lanx Anterior Cervial Plate System

  Class II

  FDA 510(k) K040401 Active Cleared 12 Apr 2004

• Lanx Anterior Plating System

  Class II

  FDA 510(k) K092765 Active Cleared 7 Apr 2010

• Lanx Posterior Cervicothoracic Spinal Fixation System (Pcfs)

  Class II

  FDA 510(k) K113434 Active Cleared 19 Dec 2011

See all devices from Lanx, Inc. →

• What materials are used in the Lanx Fusion System implants, and how do they contribute to spinal stability?

  The Lanx Fusion System uses polyetheretherketone (PEEK) and titanium alloy for its implants. PEEK provides a bone-like stiffness and radiolucency for better imaging, while the titanium alloy components enhance structural integrity and are designed to integrate with the spine. The hollowed areas allow for placement of autogenous bone graft, promoting fusion, and the transverse grooves increase surface area for additional stability during healing.

• Is the Lanx Fusion System compatible with MRI scans, and if so, why does that matter for patients?

  Yes, the titanium components of the Lanx Fusion System are MRI-safe, meaning they won’t interfere with MRI imaging. This is important for patients who may need follow-up scans, as it avoids the risks of artifacts or heating that can occur with non-MRI-compatible metals, ensuring safer long-term monitoring.

• How is the Lanx Fusion System packaged and prepared for use, and what does ‘sterile’ mean in this context?

  The system is supplied sterile in its original packaging, meaning it’s free from viable microorganisms that could cause infection. This ensures safety for single-use in spinal fusion procedures. The packaging is designed to maintain sterility until the device is opened immediately before surgery, following standard medical device sterilization practices.

• Can the Lanx Fusion System be reused, or is it intended for one-time use only?

  The Lanx Fusion System is intended for single-use only, as explicitly stated in its design and regulatory submission. Reusing implants could compromise sterility, structural integrity, or patient safety, so it must be discarded after one surgical procedure.