Snap-Off Self-Compressive Screw
FDA 510(k)Class II (US FDA 510(k))
by Neosteo
Identifiers
- 510(k) Number
- K150772 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 Snap-Off Self-Compressive Screw is an orthopedic device classified as a non-bioabsorbable, sterile bone screw. It is designed for the fixation of bone fractures and bone reconstruction in forefoot surgery, providing secure internal fixation through self-compression.
This screw is supplied sterile and intended for single-use in surgical settings. It features a self-tapping mechanism requiring no additional tapping, with a snap-off design to facilitate insertion and final tightening. The device is authorised under FDA 510(k) clearance (K150772) and is identified in the Global Unique Device Identification Database (GUDID) as 33701173702958.
Frequently asked questions
What types of surgical procedures is the Snap-Off Self-Compressive Screw intended for, and why is self-compression important in these cases?
The Snap-Off Self-Compressive Screw is designed specifically for forefoot surgery, particularly for fixing bone fractures and reconstructing bone structures. Self-compression is important because it provides immediate, stable fixation without requiring additional tools or manual tightening, reducing surgical time and minimizing the risk of loosening during the healing process. The screw’s self-tapping mechanism ensures secure placement, while the snap-off feature allows for controlled final tightening.
Is the Snap-Off Self-Compressive Screw reusable, or is it meant for single-use only? How does this affect its clinical use?
The Snap-Off Self-Compressive Screw is explicitly intended for single-use only in surgical settings, as stated in its description. This design choice ensures sterility and reduces the risk of cross-contamination or device degradation between procedures, which is critical in orthopedic surgery where infection control and reliability are paramount. Single-use also simplifies inventory management and disposal protocols.
What sizes or models of the Snap-Off Self-Compressive Screw are available, and how does the snap-off feature influence its handling?
While the provided data does not specify exact sizes or model variants, the snap-off design is a key feature that distinguishes this screw from traditional orthopedic fixation devices. This mechanism allows surgeons to insert the screw initially and then snap off the excess thread, enabling precise final tightening without over-torquing. This design simplifies handling, reduces the risk of hardware protrusion, and may improve patient comfort post-surgery.
How is the Snap-Off Self-Compressive Screw sterilized, and what storage conditions should be followed to maintain its integrity?
The Snap-Off Self-Compressive Screw is supplied sterile, though the specific sterilization method (e.g., gamma irradiation, ethylene oxide) isn’t detailed in the provided data. For storage, it should be kept in its original packaging until use to preserve sterility and prevent contamination. The device should be stored in a clean, dry environment away from direct sunlight or extreme temperatures, as recommended for most sterile medical implants.
How can I verify the regulatory compliance of this device before purchasing or using it in a clinical setting?
The Snap-Off Self-Compressive Screw holds FDA 510(k) clearance (K150772), meaning it has been deemed substantially equivalent to a legally marketed predicate device. Its compliance can be verified through the Global Unique Device Identification Database (GUDID) using the provided GUDID number (33701173702958). Additionally, the device is classified under the Orthopedic (OR) advisory committee and carries the product code HWC, which categorizes it for orthopedic fixation purposes.
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: Snap-Off Self-Compressive Screw by NEOSTEO | FDA 510 (k) Summary, PDF Neosteo, PDF DynafitSystem - sermebi97, Snap-off self compressive screw Medical Device Identification
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K150772 | Class II | Active |
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Manufacturer
- Manufacturer
- Neosteo
Sources (1)
- FDA 510(k) K150772 24 fields · synced Sep 19, 2026