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Quick-Start Orthopaedic Fixation Screw and Reverse Thread Screw

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K231819

by Innovate Orthopaedics Limited

Identifiers

510(k) Number
K231819 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)

This device is a Fixation Screw (HWC) designed for orthopaedic applications, combining standard and reverse-threaded screws to facilitate secure bone fixation. It is intended for use in procedures requiring stable internal fixation, such as fracture stabilization or joint reconstruction, where precise screw placement and retention are critical.

The Quick-Start Orthopaedic Fixation Screw and Reverse Thread Screw is supplied sterile and intended for single-use. It is classified under the Medical Device Directive (MDD) and Medical Device Regulation (MDR), with FDA 510(k) clearance (K231819) via a Substantially Equivalent determination by the Orthopaedic (OR) Advisory Committee. Compliance with Traditional 510(k) review standards ensures adherence to regulatory requirements for orthopaedic fixation devices.

Frequently asked questions

What types of orthopaedic procedures is this fixation screw designed to support, and why does it include both standard and reverse-threaded screws?

This device is designed for procedures requiring stable internal fixation, such as fracture stabilization or joint reconstruction. The combination of standard and reverse-threaded screws allows for greater flexibility in placement, ensuring secure fixation in varied anatomical orientations. The reverse thread helps prevent loosening or back-out, particularly in cases where screw direction is constrained by bone structure or surgical approach.

Is this screw system reusable, or is it intended for single-use only? How does this affect its sterility?

The Quick-Start Orthopaedic Fixation Screw is explicitly intended for single-use only, as stated in the device description. This design choice ensures sterility is maintained throughout its use, as it is supplied sterile from the manufacturer. Reuse could compromise sterility and compromise patient safety, so adherence to single-use guidelines is critical.

What regulatory pathways has this device undergone, and how does the FDA’s 510(k) clearance impact its use in the U.S.?

This device received FDA 510(k) clearance (K231819) through a *Substantially Equivalent* determination by the Orthopaedic (OR) Advisory Committee, following a *Traditional 510(k)* review. This means it meets FDA standards for orthopaedic fixation devices and is considered safe and effective for its intended uses, such as fracture stabilization or joint reconstruction, when used as directed. The clearance ensures compliance with U.S. regulatory requirements for orthopaedic hardware.

How is this screw system packaged and stored to maintain its sterile condition?

While the exact packaging details aren’t specified, the device is supplied sterile, which implies it is likely packaged in a sterile barrier system (e.g., sealed pouch or sterile tray) to preserve sterility until use. Proper storage should follow manufacturer instructions—typically in a clean, dry environment away from direct sunlight or extreme temperatures to prevent contamination or degradation before opening.

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

European Union Active

MDD

United States Active

FDA_510K

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Manufacturer

Manufacturer
Innovate Orthopaedics Limited

Sources (2)

  • FDA 510(k) K231819 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced Jun 19, 2026