Prow Fusion

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

510(k) Number

K151654 ↗

FDA Product Code

MAX

Device Class

Class II

Regulation

21 CFR Part 888.3080

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• Prow Fusion-L

  Class II

  FDA 510(k) K153665 Active Cleared 15 Sep 2016

• 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

• ESPIN System

  Class II

  FDA 510(k) K133061 Active Cleared 27 Nov 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 procedures is the PROW FUSION device designed for, and how does its expandable design benefit the surgery?

  The PROW FUSION is specifically designed for transforaminal lumbar interbody fusion (TLIF) procedures, which involve fusing one or two adjacent vertebral levels in the lumbar spine. Its expandable variants allow surgeons to adjust the implant size intraoperatively, accommodating varying anatomical dimensions and ensuring a secure fit while maintaining stability during fusion. This adaptability can help optimize spinal alignment and reduce the need for additional adjustments during surgery.

• Is the PROW FUSION device intended for reuse, or is it meant to be used only once per patient?

  The PROW FUSION is supplied sterile and explicitly intended for single-use only per patient. This design choice aligns with best practices for spinal implants to minimize infection risks and ensure consistent performance, as reuse could compromise sterility and structural integrity.

• What surgical approaches does the PROW FUSION support, and how does the manufacturer categorize its regulatory classification?

  The PROW FUSION is engineered for multiple surgical approaches, including standard TLIF techniques, and is available in expandable designs to adapt to different patient anatomies. Regulatory-wise, it falls under the Orthopedic advisory committee (OR) classification and was cleared via the Special 510(k) review pathway, demonstrating equivalence to a predicate device under FDA guidelines.

• How should the PROW FUSION device be stored to maintain its sterility and integrity before use?

  Since the PROW FUSION is supplied sterile, it should be stored in its original, unopened packaging in a clean, dry environment away from direct sunlight or extreme temperatures. The packaging is designed to preserve sterility until the first use, so any breach—such as removing the device from its sterile barrier—would invalidate its sterile status. Always follow the manufacturer’s instructions for handling to prevent contamination.