RegulatorySpine

Life Spine Announces FDA 510(k) Clearance for the PROLIFT® Wedge Expandable Spacer System

March 18, 2021

HUNTLEY, Ill.–(BUSINESS WIRE)–Life Spine, a leading medical device company that designs, develops, manufactures and markets products for the surgical treatment of spinal disorders, announced today that it has received clearance from the U.S. Food & Drug Administration (FDA) to market the PROLIFT Wedge Expandable Spacer System.

The PROLIFT Wedge Expandable Interbody Spacer System with OSSEO-LOC™ Surface Technology is a lordotic expandable implant for Micro Invasive TLIF and PLIF procedures. The device maintains coronal alignment while achieving sagittal correction through controlled lordotic expansion of up to 15 degrees. The implant is designed with multiple implant heights and widths to optimally fit the patient’s disc anatomy. Once the patient specific correction has been achieved, PROLIFT Wedge is auto locked in position and can be packed with graft in situ through the OSTEO-LINE™ Graft Delivery Device.

“The launch of PROLIFT Wedge furthers our commitment to offering patient matched expandable solutions,” said Mariusz Knap, Sr. Vice President of Sales and Marketing for Life Spine. “PROLIFT Wedge is another innovative expandable interbody added to our existing portfolio providing surgeons with multiple solutions for improving patient care.”

The PROLIFT Wedge Expandable Spacer System marks the company’s 11th expandable 510(k) clearance that includes expandable solutions for PLIF, TLIF, and LATERAL procedures.

PROLIFT Wedge Key Features and Benefits:

  • Up to 15˚ of Controlled Lordotic Expansion with Auto Lock
  • Widths: 10 and 12mm, Heights: 8 – 16mm
  • Osseo-Loc Surface Technology with 400-600 Micron Porosity
  • Ability to Collapse/Expand In Situ and Reposition
  • Visual and Tactile Confirmation to Prevent Over Distraction
  • In situ graft delivery

About Life Spine

Life Spine is dedicated to improving the quality of life for spinal patients by increasing procedural efficiency and efficacy through innovative design, uncompromising quality standards, and the most technologically advanced manufacturing platforms. Life Spine, which is privately held, is based in Huntley, Illinois. For more information, please visit: http://www.lifespine.com and/or https://www.micro-invasive.com.

Contacts

Mr. Omar Faruqi
Chief Financial Officer
ofaruqi@lifespine.com
847-884-6117

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Chris J. Stewart

Chris currently serves as President and CEO of Surgio Health. Chris has close to 20 years of healthcare management experience, with an infinity to improve healthcare delivery through the development and implementation of innovative solutions that result in improved efficiencies, reduction of unnecessary financial & clinical variation, and help achieve better patient outcomes. Previously, Chris was assistant vice president and business unit leader for HPG/HCA. He has presented at numerous healthcare forums on topics that include disruptive innovation, physician engagement, shifting reimbursement models, cost per clinical episode and the future of supply chain delivery.

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