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ArcadiusXP C Spinal System

FDA 510(k)

Class II (US FDA 510(k))

510(k) K153629

by Aesculap Implant Systems, Inc.

Identifiers

510(k) Number
K153629 FDA 510(k)
FDA Product Code
OVE FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 888.3080 FDA 510(k)
Regulation Number
888.3080 FDA 510(k)
Advisory Committee
Orthopedic FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The ArcadiusXP C Spinal System is a spinal implant system designed for anterior cervical discectomy and fusion (ACDF) procedures. It is offered in various heights and geometrical options to fit the anatomical needs of a wide variety of patients, with two available footprints and a wide central opening to hold optimal graft material.

The system includes screws that are 4mm in diameter and offered in three lengths. It is intended for single and multilevel stand-alone ACDF procedures and requires anterior access for insertion. The device received FDA 510(k) clearance (K153629) and is classified under product code OVE.

Frequently asked questions

What is the ArcadiusXP C Spinal System used for?

The ArcadiusXP C Spinal System is intended for anterior cervical discectomy and fusion (ACDF) procedures, including both single-level and multilevel stand-alone applications, requiring anterior surgical access for implantation.

What sizes and configurations are available for the ArcadiusXP C Spinal System?

The system is offered in various heights and two different footprints to accommodate diverse patient anatomy, featuring a wide central opening to hold graft material, and includes 4mm diameter screws available in three lengths.

Is the ArcadiusXP C Spinal System reusable or single-use?

The device description does not specify whether the ArcadiusXP C Spinal System is intended for single-use or reuse; therefore, reusability cannot be determined from the provided information.

How is the ArcadiusXP C Spinal System supplied or packaged?

The supplied state or packaging details of the ArcadiusXP C Spinal System are not included in the device data, so no information about its delivery format, sterility, or storage can be provided.

What regulatory pathway was used for the ArcadiusXP C Spinal System?

The ArcadiusXP C Spinal System received FDA 510(k) clearance under submission number K153629 and is classified under product code OVE, indicating it was found substantially equivalent to a predicate device.

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: PDF Aesculap® Implant Systems Arcadius XP C Spinal System: Instructions for Use, PDF Arcadius®XP C Spinal System - SPINEMarketGroup, ArcadiusXP C® | B. Braun

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Aesculap Implant Systems, Inc.

Sources (1)

  • FDA 510(k) K153629 24 fields · synced Sep 24, 2026