Post-market Surveillance Study of FLXfit™ TLIF Interbody Fusion Device

2016-06-20 18:53:21 | BioPortfolio


This study is a post-market clinical follow-up study. A post-market, prospective clinical trial will be conducted. The data collected from this study will serve the purpose of confirming safety and performance of the FLXfit™ implant.


As detailed by Expanding Orthopedics Inc., the FLXfit™ is an expandable, articulated interbody fusion device (IBFD) used in conjunction with supplemental fixation to provide structural stability in skeletally mature individuals following total or partial discectomy.

The FLXfit™ is a unique titanium cage which articulates laterally as well as expands in height. This enables larger footprint support as well as restoration of disc height and lordotic angle correction. A bullet-nose design facilitates self-distraction and ease of insertion. The open architecture of the device allows it to be packed with autogenous bone graft.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Degenerative Disc Disease


FLXfit™ TLIF Interbody Fusion Device


Rush University Medical Center; Department of Orthopedic Surgery
United States


Not yet recruiting


Rush University Medical Center

Results (where available)

View Results


Published on BioPortfolio: 2016-06-20T18:53:21-0400

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Medical and Biotech [MESH] Definitions

Degenerative changes in the INTERVERTEBRAL DISC due to aging or structural damage, especially to the vertebral end-plates.

The dissolving of the NUCLEUS PULPOSUS, the semi-gelatinous tissue of a displaced INTERVERTEBRAL DISC. It is usually achieved by the direct injection of a proteolytic enzyme, especially CHYMOPAPAIN, into the herniated disc.

Fibrocartilage inner core of the intervertebral disc. Prolapsed or bulged nucleus pulposus leads to INTERVERTEBRAL DISC DISPLACEMENT while proliferation of cells in the nucleus pulposus is associated with INTERVERTEBRAL DISC DEGENERATION.

An INTERVERTEBRAL DISC in which the NUCLEUS PULPOSUS has protruded through surrounding ANNULUS FIBROSUS. This occurs most frequently in the lower lumbar region.

Removal of a MEDICAL DEVICE from the market due to the identification of an intrinsic property of the device that results in a serious risk to public health.

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