LTD Polyaxial Fixation System

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

510(k) Number

K062785 ↗

FDA Product Code

KWP

Device Class

Class II

Regulation

21 CFR Part 888.3050

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• Us Spine Facet Fixation System

  Unclassified

  FDA 510(k) K061041 Active Cleared 19 Jun 2006

• Preference Pedicle Screw System

  Class II

  FDA 510(k) K081296 Active Cleared 6 Jun 2008

• Modification to Preference Pedicle Screw System

  Class II

  FDA 510(k) K081883 Active Cleared 24 Sep 2008

• Phantom Plus Cage System

  Class II

  FDA 510(k) K082801 Active Cleared 22 Dec 2008

• What spinal regions is the LTD Polyaxial Fixation System approved for use in, and why is this important for my procedure planning?

  The LTD Polyaxial Fixation System is specifically designed for the non-cervical posterior spine, meaning it is intended for the lumbar or sacral regions only. This distinction is critical because cervical spine procedures require different hardware due to anatomical and biomechanical differences. The polyaxial design allows for adjustable, multi-directional stabilization, which is particularly useful in these regions for surgical fusion in cases of degenerative conditions, fractures, or post-surgical failures.

• Is the LTD Polyaxial Fixation System intended for reuse, and if not, how should it be handled to maintain sterility?

  The system is explicitly intended for single-use only, as stated in its description. Since it is supplied sterile, proper sterile medical device protocols must be followed during storage and handling to prevent contamination. This includes maintaining sealed packaging until immediate preoperative use and adhering to facility-specific sterile processing guidelines for orthopedic implants.

• What types of spinal conditions or complications is this system commonly used to address, and how does its polyaxial design benefit those cases?

  The LTD Polyaxial Fixation System is intended for degenerative conditions, fractures, dislocations, tumors, or prior surgical failures in the lumbar or sacral spine. The polyaxial design provides adjustable, multi-directional stabilization, which helps accommodate natural spinal motion and reduces stress on the fixation points—particularly useful in cases where precise alignment or load-sharing is required for successful fusion.

• How is the regulatory status of this device relevant to my purchase or clinical use, and what does the FDA 510(k) clearance indicate?

  The device holds FDA 510(k) clearance (K062785) under a Special 510(k) review, classified under the orthopedic product code KWP. This clearance indicates that the FDA has determined the system is substantially equivalent to a legally marketed predicate device, meaning it meets the agency’s requirements for safety and effectiveness for its intended uses. Clinically, this ensures the device adheres to U.S. regulatory standards for spinal fixation hardware, though local facility protocols and surgeon preference may still influence adoption.