LimiFlex Dynamic Sagittal Tether
by Empirical Spine, Inc. PMA
Active
PMA P220031
Overview
The LimiFlex Dynamic Sagittal Tether is a Prosthesis, Spinous Process Tension Band Implant, classified as a Class III device under FDA regulations. This device is designed to provide dynamic stabilization of the spine by applying controlled tension across spinous processes, promoting sagittal alignment while allowing limited motion to reduce spinal stiffness.
Intended for surgical use, the LimiFlex Dynamic Sagittal Tether is supplied sterile and intended for single-patient use. It is implanted via an orthopedic procedure, typically in the lumbar or thoracic spine, and is regulated under FDA_PMA (PMA Number: P220031). The device is manufactured by Empirical Spine, Inc. and must be stored according to manufacturer instructions to maintain sterility and functionality.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA PMAAPPR | NumberP220031 | Date12 Feb 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA PMA Active
Recalls
No FDA recalls on record, checked 6 Oct 2026.
Specification
- Generic Name
- Prosthesis, spinous process tension band implant
- PMA Number
- FDA Product Code
- SGK
- Device Class
- Class III
- Advisory Committee
- Orthopedic
- FDA Decision
- APPR Approved
Other devices from Empirical Spine, Inc.
Questions
What is the LimiFlex Dynamic Sagittal Tether primarily used for in spinal procedures?
The LimiFlex Dynamic Sagittal Tether is designed to provide dynamic stabilization of the spine by applying controlled tension across spinous processes. This helps maintain sagittal alignment while allowing limited motion, which can reduce spinal stiffness—particularly useful in lumbar or thoracic spine surgeries where traditional rigid fixation might be avoided.
Is the LimiFlex Dynamic Sagittal Tether intended for single-use or reusable applications?
The LimiFlex Dynamic Sagittal Tether is explicitly supplied sterile and intended for **single-patient use only**. This ensures patient safety and sterility, as reuse could compromise integrity and introduce infection risks.
How should the LimiFlex Dynamic Sagittal Tether be stored to maintain its functionality?
The device must be stored according to the manufacturer’s instructions provided by Empirical Spine, Inc. Proper storage is critical to preserve sterility and ensure the tether’s mechanical properties remain intact for surgical use.
What regulatory pathway does the LimiFlex Dynamic Sagittal Tether follow, and what does that mean for its use?
The LimiFlex Dynamic Sagittal Tether follows the **FDA PMA (Premarket Approval) pathway**, indicated by PMA Number **P220031**. This means it has undergone rigorous review by the FDA to demonstrate safety and effectiveness for its intended surgical use as a dynamic stabilization device, ensuring compliance with Class III device regulations.