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IBS-B MIS Beveled Screw System

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K231236

by In2Bones USA, LLC

Identifiers

510(k) Number
K231236 FDA 510(k)
FDA Product Code
HWC FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 888.3040 FDA 510(k)
Regulation Number
888.3040 FDA 510(k)
Advisory Committee
Orthopedic FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The IBS-B MIS Beveled Screw System is a minimally invasive orthopedic fixation device designed for spinal stabilization procedures. It features beveled screws intended to enhance screw purchase and reduce the risk of pull-out in bone, particularly in challenging anatomical regions.

This system is supplied sterile and intended for single-use in surgical settings. It is classified under product code HWC and has received FDA 510(k) clearance as substantially equivalent to a predicate device, with additional conformity under the EU Medical Device Regulation (MDR). The beveled design is engineered for compatibility with minimally invasive spinal techniques, and the system is regulated as a Class II orthopedic device in the United States.

Frequently asked questions

What types of spinal procedures is the IBS-B MIS Beveled Screw System designed for, and why is the beveled screw important in these cases?

The IBS-B MIS Beveled Screw System is designed for minimally invasive spinal stabilization procedures, where secure fixation is critical. The beveled screw design enhances bone purchase—especially in challenging anatomical regions—by increasing surface contact and reducing the risk of pull-out during stabilization. This is particularly useful in procedures where traditional screws might struggle due to bone density or angle constraints.

Is the IBS-B MIS Beveled Screw System intended for reuse, or is it meant to be used only once in surgery?

The system is sterile and intended for single-use only, as explicitly stated in the manufacturer’s description. This aligns with best practices for orthopedic fixation devices to ensure patient safety and prevent cross-contamination in surgical settings.

What product code and regulatory classification does the IBS-B MIS Beveled Screw System fall under in the U.S., and how does this affect its use?

The system is classified under product code HWC and is regulated as a Class II orthopedic device in the U.S. This classification means it undergoes stricter scrutiny than Class I devices but does not require the same level of oversight as Class III. The FDA granted it 510(k) clearance, determining it to be *substantially equivalent* to a predicate device, which allows it to be marketed for spinal stabilization procedures under the existing regulatory framework.

How should the IBS-B MIS Beveled Screw System be stored, and what precautions should be taken given its sterile packaging?

Since the system is supplied sterile, it should be stored in its original, unopened packaging to maintain sterility until use. The packaging should be kept in a clean, dry environment, protected from moisture, extreme temperatures, and direct sunlight. Always follow the manufacturer’s instructions for storage duration and handling to ensure the device remains uncontaminated before surgery.

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.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDR

United States Active

FDA_510K

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Manufacturer

Manufacturer
In2Bones USA, LLC

Sources (2)

  • FDA 510(k) K231236 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced May 18, 2026