Lanx Spinal Fixation System

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K120399 ↗

FDA Product Code

NKB

Device Class

Class II

Regulation

21 CFR Part 888.3070

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 is the Lanx Spinal Fixation System used for?

  The Lanx Spinal Fixation System is designed for posterior spinal stabilization in skeletally mature patients, specifically for non-cervical segments (T1 through S2/ilium). It is intended as an adjunct to spinal fusion to address instabilities or deformities, such as those caused by degenerative disc disease. The system achieves segmental control through rigid fixation hardware, including pedicle screws, rods, and connectors, ensuring immobilization of affected spinal segments.

• How is the Lanx Spinal Fixation System supplied, and is it single-use?

  The system is supplied as a modular assembly pre-packaged for immediate surgical use. Components are intended for single-use only, meaning they are not designed to be reprocessed or reused after a single surgical procedure. This ensures sterility and safety for each patient.

• Does the Lanx Spinal Fixation System require any special handling or storage?

  Yes, the system requires sterile handling as per manufacturer guidelines due to its single-use nature. Proper storage conditions must be maintained to preserve sterility and functionality until use. The manufacturer provides specific storage instructions to ensure the system remains intact and ready for surgery.

• Is the Lanx Spinal Fixation System MRI-safe?

  No, the Lanx Spinal Fixation System is explicitly stated as not MRI-safe. This means it should not be used in patients who require MRI imaging after surgery, as the device could interfere with the imaging process or pose risks during the scan.

• What regulatory approval does the Lanx Spinal Fixation System hold?

  The Lanx Spinal Fixation System holds FDA 510(k) clearance under the reference number K120399. This clearance confirms that the device is substantially equivalent to a predicate device, meeting regulatory standards for safety and effectiveness as determined by the FDA.