L&K Biomed Granted FDA Clearance for Expandable Interbody

By Julie A. Vetalice

L&K Biomed Granted FDA Clearance for Expandable Interbody

L&K Biomed obtained FDA clearance to market PathLoc™, a next-generation height-expandable spinal implant product for the treatment of spinal diseases.

PathLoc is used in the posterior and posterolateral positions, where the procedure is most frequently performed in spinal implants.

According to L&K Biomed, the expandable interbody cage can be inserted with a minimum height, allowing minimally invasive surgery with a minimum incision. In addition, this feature raises patient satisfaction after surgery, the company said.

PathLoc is designed in an H shape to fill more bone graft materials than existing products, with the intent to improve bone fusion. In addition, depending on the patient's spine positions, the angle of insertion (up to 20 degrees), the length (up to 25 mm), and the height (up to 4 mm) can be extended.

Direct U.S. sales through a regional branch is expected to be established in the first half of the year.

Source: L&K Biomed

Product Labels: Spinal Fusion

Tags: 510(k) Clearance, Regulatory