Flxfit Intervertebral Body Fusion Device
by Expanding Orthopedics, Inc. 510(k)
Active
510(k) K133813
Overview
The Flxfit Intervertebral Body Fusion Device is a titanium alloy implant featuring an articulated, expandable design. It is engineered to provide lordosis correction and sagittal balance restoration through controlled in-situ expansion.
This device is implanted via a transforaminal approach and requires the use of supplemental posterior spinal fixation and autogenous bone graft. The system is available in height ranges from 8mm to 14mm and is authorized under FDA 510(k) clearance.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK133813 | Date15 Jul 2014 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- MAX
- Device Class
- Class II
- Regulation
- 21 CFR Part 888.3080
- Advisory Committee
- Orthopedic
- FDA Decision
- SESE Substantially Equivalent
Other devices from Expanding Orthopedics, Inc.
Questions
What is the primary function of the Flxfit Intervertebral Body Fusion Device?
The device is a titanium alloy implant engineered to provide lordosis correction and restore sagittal balance. It achieves this through a controlled, articulated, and expandable design that allows for in-situ expansion once placed within the intervertebral space.
How is the Flxfit device implanted?
The system is designed for implantation via a transforaminal approach. To ensure proper stability and fusion, the procedure requires the use of supplemental posterior spinal fixation and the addition of autogenous bone graft.
What size range is available for this fusion device?
The Flxfit Intervertebral Body Fusion Device is available in a variety of heights ranging from 8mm to 14mm to accommodate different patient anatomical requirements during the fusion procedure.
What is the regulatory status of this device?
The Flxfit Intervertebral Body Fusion Device is authorized under FDA 510(k) clearance, having been determined to be substantially equivalent to predicate devices for its intended use.