QWIX Positioning Screw
FDA 510(k)Class II (US FDA 510(k))
by Newdeal Sas
Identifiers
- 510(k) Number
- K071639 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 QWIX Positioning Screw is a cannulated, fully threaded, self-tapping orthopedic fixation device designed for bone stabilization. It is classified as a bone screw (HWC) and manufactured from titanium alloy (Ti-6Al-4V ELI) to ensure biocompatibility and strength for surgical applications.
This device is used in orthopedic procedures for bone fragment fixation, osteotomies, and arthrodesis in the hand, foot, or ankle. Available in diameters of 5.5 mm and 7.5 mm with lengths ranging from 30 mm to 120 mm, it is supplied sterile and intended for single-use. The QWIX Positioning Screw holds FDA 510(k) clearance (K071639) under the Special 510(k) review pathway for orthopedic devices.
Frequently asked questions
What types of orthopedic procedures is the QWIX Positioning Screw designed for, and why is titanium alloy used in its construction?
The QWIX Positioning Screw is designed for bone stabilization in orthopedic procedures such as bone fragment fixation, osteotomies, and arthrodesis, specifically in the hand, foot, or ankle. Titanium alloy (Ti-6Al-4V ELI) is used because it provides excellent biocompatibility—reducing the risk of adverse reactions—and high strength-to-weight ratio, ensuring durability and reliability during surgical fixation.
Are the QWIX Positioning Screws reusable, and if not, how should they be handled to maintain sterility?
The QWIX Positioning Screws are intended for single-use only. Since they are supplied sterile, they must remain in their original, unopened packaging until immediately before use to preserve sterility. Any exposed or contaminated screws should not be reused.
What sizes are available for the QWIX Positioning Screw, and how might a clinician choose between them?
The QWIX Positioning Screw comes in two diameters—5.5 mm and 7.5 mm—with lengths ranging from 30 mm to 120 mm. The choice depends on the anatomical site and fixation requirements: smaller diameters (5.5 mm) may be used for delicate or smaller bones, while larger diameters (7.5 mm) offer greater pull-out resistance for heavier loads or larger bone fragments.
How is the QWIX Positioning Screw regulated in the U.S., and what does the Special 510(k) pathway mean for its approval?
The QWIX Positioning Screw holds FDA 510(k) clearance (K071639) under the Special 510(k) review pathway, specifically for orthopedic devices. This pathway is used when a device is substantially equivalent to a predicate (already cleared) device, allowing for a streamlined review process. The clearance confirms it meets FDA standards for safety and effectiveness as an orthopedic fixation 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: QWIX POSITIONING SCREW (K071639) — FDA 510 (k) | Innolitics, PDF Q~~ewdeal® 1W~39 n - Food and Drug Administration, QWIX POSITIONING SCREW 510(k) K071639 - FDA.report, PDF Q~~ewdeal® 1W~39 n - Food and Drug Administration
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K071639 | Class II | Active |
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Manufacturer
- Manufacturer
- Newdeal Sas
Sources (1)
- FDA 510(k) K071639 24 fields · synced Sep 19, 2026