Identifiers
- 510(k) Number
- K242348 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 Smooth or Threaded Metallic Bone Fixation Fastener (21 CFR 888.3040), classified as a Screw, Fixation, Bone (product code HWC). Constructed from cobalt-chromium-molybdenum alloy (CoCrMo), it is designed for secure fixation in orthopedic applications, providing mechanical stability to bone structures through locking engagement.
The Locking Screw, CoCrMo is supplied sterile and intended for single-use. It is regulated under FDA 510(k) clearance (K242348) and MDR, with a Class II designation under special controls. Available in standard sizes as specified in the device’s technical documentation, it is intended for use in orthopedic surgical settings where precise fixation is required. No additional storage conditions beyond standard medical device protocols are noted.
Frequently asked questions
What materials is this locking screw made from and why is that important for orthopedic use?
This locking screw is made from cobalt-chromium-molybdenum alloy (CoCrMo), a durable and corrosion-resistant material commonly used in orthopedic implants. CoCrMo is favored for its high strength, biocompatibility, and ability to withstand the mechanical stresses of bone fixation, ensuring long-term stability and reducing the risk of failure or loosening in surgical applications.
Is this screw intended for reuse in clinical settings, and if not, how should it be handled after use?
No, this locking screw is explicitly designed for single-use only and is supplied sterile. After use, it should be disposed of according to standard medical waste protocols to prevent contamination and ensure patient safety. Reusing it could compromise sterility and integrity, leading to potential complications.
What types of bone fixation applications is this screw suitable for, and how does the locking mechanism work?
This screw is designed for secure fixation in orthopedic applications, particularly where mechanical stability is critical—such as in fracture fixation, spinal stabilization, or joint reconstruction. The locking engagement mechanism ensures tight attachment to bone or implant surfaces, reducing micromotion and promoting proper healing by maintaining alignment.
Are there specific storage requirements for this device beyond standard medical device protocols?
No additional storage conditions are specified beyond standard medical device protocols. Since it is supplied sterile and intended for single-use, it should be stored in a clean, dry environment protected from moisture, dust, or physical damage until use, following facility-specific guidelines for orthopedic implants.
How do I confirm the regulatory approval status of this device before use?
This device holds FDA 510(k) clearance (K242348) and is classified under MDR (Medical Device Regulation) with a Class II designation for orthopedic fixation screws. For verification, you can reference the FDA’s [510(k) database](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pma.cfm) using the clearance number or consult the manufacturer’s documentation, which should include regulatory markings and compliance details.
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: Locking Screw,CoCrMo (K242348) — FDA 510 (k) | Innolitics, K242348 FDA 510 (k) - Locking Screw, Double Medical Technology, Inc. FDA 510 (k) Products - Latest 2025
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K242348 | Class II | Active |
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Manufacturer
- Manufacturer
- Double Medical Technology Inc.
- FDA Applicant
- Double Medical Technology, Inc.
Sources (2)
- FDA 510(k) K242348 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 19, 2026