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L&K Biomed's BluEX Lumbar Expandable Cage System Receives FDA Approval

• L&K Biomed secured FDA 510(k) clearance for its BluEX Lumbar Expandable Cage System, designed for enhanced bone integration and versatile surgical approaches. • The BluEX system features six cage designs adaptable for anterior, posterior, lateral, ATP, and endoscopic lumbar approaches, offering surgeons greater flexibility. • Its expandable design allows precise intraoperative height adjustments, optimizing placement and fit based on individual patient needs, potentially reducing recovery time. • A phased rollout of the BluEX system is planned in select U.S. markets, with a nationwide release expected early next year, according to L&K Biomed.

L&K Biomed has received FDA 510(k) clearance for its BluEX Lumbar Expandable Cage System, a state-of-the-art spine implant solution designed to improve bone integration and offer versatility in surgical approaches. The system includes six unique cage designs tailored for anterior, posterior, lateral, ATP, and endoscopic spine surgery.

Key Features of the BluEX System

The BluEX Lumbar Expandable Cage System is engineered to meet diverse patient and surgical needs. Its surface technology enhances bone growth and integration, providing a micro-textured surface that encourages cell adhesion and osseointegration, which is critical for long-term spinal stability and fusion success.
"This FDA clearance is a significant milestone, enabling us to introduce a truly versatile solution in spinal fusion," said Alex Kang, General Manager of L&K BIOMED/CEO of L&K Spine. "With six cage designs that can be adapted for virtually any lumbar approach, including endoscopic techniques, the BluEX System demonstrates our commitment to advancing the possibilities for surgeons and improving patient outcomes."
The BluEX System’s expandability allows for precise, intraoperative height adjustment, giving surgeons control to customize placement and fit based on individual patient needs. This multi-approach adaptability, combined with the enhanced surface technology, is designed to streamline procedures, reduce recovery time, and maximize fusion potential.

Surgical Approaches

The BluEX Lumbar Expandable Cage System supports the following surgical approaches:
  • BluEX-T: TLIF and PLIF
  • BluEX-TC: Endoscopic TLIF
  • BluEX-ATP: ATP and LLIF
  • BluEX-L: LLIF
  • BluEX-LT: LLIF (Deformity)
  • BluEX-A: ALIF

Availability

L&K BIOMED, along with its exclusive distributor L&K Spine INC., plans to begin a phased rollout of the BluEX Lumbar Expandable Cage System, starting with select markets in the U.S., with a nationwide release anticipated in early next year.
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Reference News

[1]
L&K Biomed earns FDA approval for new lumbar spine device
beckersspine.com · Oct 31, 2024

L&K BIOMED's BluEX Lumbar Expandable Cage System, featuring six unique cage designs for various surgical approaches incl...

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