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S4 Spinal System

FDA 510(k)

Class II (US FDA 510(k))

510(k) K130291

by Aesculap Implant System, Inc.

Identifiers

510(k) Number
K130291 FDA 510(k)
FDA Product Code
NKB FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 888.3070 FDA 510(k)
Regulation Number
888.3070 FDA 510(k)
Advisory Committee
Orthopedic FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The S4 Spinal System is a pedicle fixation device designed for spinal stabilization and fusion procedures. It is classified under the product code NKB and is intended for use in orthopedic spinal applications, providing modular components for adjustable fixation in the lumbar and thoracolumbar regions.

This system is supplied as a reusable surgical implant and is intended for use in controlled clinical settings. The S4 Spinal System has received FDA clearance under a 510(k) submission (K130291) as substantially equivalent to a predicate device, with no third-party involvement. It is configured for open and minimally invasive surgical approaches, offering adaptability to various spinal pathologies and surgical techniques.

Frequently asked questions

What types of spinal procedures is the S4 Spinal System designed to support, and how does its modularity benefit surgeons?

The S4 Spinal System is specifically designed for spinal stabilization and fusion procedures in the lumbar and thoracolumbar regions. Its modular components allow surgeons to customize fixation based on patient anatomy and surgical approach, whether open or minimally invasive. This adaptability helps address a range of spinal pathologies and techniques, improving precision and flexibility during surgery.

Is the S4 Spinal System intended for single-use or can it be reused in multiple procedures, and where is it typically used?

The S4 Spinal System is explicitly described as a reusable surgical implant, meaning it is intended for use in controlled clinical settings across multiple procedures. It is configured for both open and minimally invasive surgical approaches, ensuring versatility in orthopedic spinal applications.

How does the regulatory pathway for the S4 Spinal System differ from typical medical devices, and what does this mean for its use?

The S4 Spinal System received FDA clearance under a 510(k) submission (K130291), classified as substantially equivalent to a predicate device in the orthopedic category (product code NKB). This means its safety and effectiveness were determined by comparison to an existing approved device, rather than through a de novo or PMA pathway. Clinically, this indicates it has undergone rigorous review for spinal fixation applications but does not imply broader indications beyond what was evaluated.

What surgical regions does the S4 Spinal System primarily target, and why is this important for clinicians?

The S4 Spinal System is primarily designed for the lumbar and thoracolumbar regions, which are common sites for degenerative disc disease, spinal instability, or post-fracture stabilization. This targeted focus ensures compatibility with procedures addressing these specific areas, helping clinicians select the right tool for their patient’s anatomical needs while maintaining modularity for varying surgical techniques.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: S4® Spinal System - B. Braun, S4® Element - B. Braun, PDF Microsoft Word - S4 SPINAL SYSTEM - LUMBAR - DEFORMITYfinal.doc

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Aesculap Implant System, Inc.

Sources (1)

  • FDA 510(k) K130291 24 fields · synced Sep 18, 2026