ESPIN System

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K133061 ↗

FDA Product Code

HRX

Device Class

Class II

Regulation

21 CFR Part 888.1100

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• Prow Fusion-L

  Class II

  FDA 510(k) K153665 Active Cleared 15 Sep 2016

• Prow Fusion

  Class II

  FDA 510(k) K151654 Active Cleared 17 Jul 2015

• Prow Fusion-V

  Class II

  FDA 510(k) K153786 Active Cleared 11 Jul 2016

• Espin

  Class II

  FDA 510(k) K130057 Active Cleared 7 Feb 2013

• Prow Fusion

  Class II

  FDA 510(k) K112359 Active Cleared 8 Nov 2011

• Prow Fusion

  Class II

  FDA 510(k) K130254 Active Cleared 16 Oct 2013

See all devices from Nlt Spine, Ltd. →

• What types of spinal surgeries is the ESPIN System specifically designed for, and how does it reduce patient trauma during procedures?

  The ESPIN System is designed for lumbar interbody fusion procedures, a common orthopedic surgery used to stabilize the spine by fusing vertebrae together. It is engineered as a minimally invasive instrument system, which means it is built to facilitate precise placement of interbody cages and other spinal implants while causing less trauma to surrounding tissues compared to traditional open-surgery methods. This reduces postoperative pain, recovery time, and potential complications.

• Is the ESPIN System reusable or single-use, and how should it be stored to maintain sterility?

  The ESPIN System is intended for single-use only in surgical settings, as specified by the manufacturer. Since it is supplied sterile, it must be stored in its original packaging until use to preserve sterility. After opening, any unused components should not be reused to prevent infection risks.

• What regulatory pathway did the ESPIN System follow to gain FDA clearance, and what does this mean for its safety and equivalence?

  The ESPIN System received FDA 510(k) clearance (K133061) under the Traditional Review pathway, meaning it was determined to be substantially equivalent to a previously approved predicate device. This classification indicates that the FDA reviewed its design, materials, and intended use to confirm it meets the same safety and effectiveness standards as the existing device. There was no third-party review involved in this process.

• Can the ESPIN System be used in procedures that require MRI compatibility, and what are its key limitations?

  The ESPIN System is not MRI-compatible, meaning it should not be used in patients who require MRI scans postoperatively. This limitation is due to the materials and design of the system, which may interfere with MRI imaging. Clinicians should confirm with radiology teams before proceeding with surgery if MRI follow-up is anticipated.