Darco Small Screw
by Wrightmedicaltechnologyinc 510(k)
Active
510(k) K082320
Overview
The Darco Small Screw is a cannulated, self-drilling, and self-tapping orthopedic screw designed for bone fixation. It is classified under the FDA product code HWC (Orthopedic Devices, Screws) and is intended for use in procedures such as fracture repair, joint fusion, and arthrodesis, particularly in forefoot, midfoot, and hindfoot anatomy.
This screw is supplied in multiple sizes, including headed diameters ranging from 2.7 mm to 7.5 mm, with a 7.0 mm headless option. It features a reverse cutting flute for ease of removal and is intended for single-use. The device holds an FDA 510(k) clearance under the Traditional pathway, with a decision date of November 5, 2008, and is regulated as a Class II medical device.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK082320 | Date5 Nov 2008 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- HWC
- Device Class
- Class II
- Regulation
- 21 CFR Part 888.3040
- Advisory Committee
- Orthopedic
- FDA Decision
- SESE Substantially Equivalent
Other devices from Wrightmedicaltechnologyinc
Questions
What types of orthopedic procedures is the Darco Small Screw designed for, and which parts of the foot does it target specifically?
The Darco Small Screw is designed for bone fixation in procedures like fracture repair, joint fusion, and arthrodesis. It is particularly suited for forefoot, midfoot, and hindfoot anatomy, making it ideal for surgeries in these regions where precise fixation is required.
Is the Darco Small Screw reusable or intended for single-use, and why?
The Darco Small Screw is intended for single-use only. This is likely due to its self-drilling and self-tapping design, which may compromise sterility and structural integrity if reused, especially in orthopedic applications where infection control and precision are critical.
What size options are available for the Darco Small Screw, and how does the headless option differ from the others?
The Darco Small Screw comes in headed diameters ranging from 2.7 mm to 7.5 mm, allowing for flexibility in surgical applications. The 7.0 mm headless option is designed for scenarios where a flush or low-profile screw is preferred, reducing the risk of soft tissue irritation or interference with adjacent structures.
How is the Darco Small Screw designed to facilitate removal, and why is this feature important?
The Darco Small Screw features a reverse cutting flute, which helps reduce friction and makes removal easier compared to traditional screws. This design is particularly useful in orthopedic procedures where screws may need to be removed for follow-up surgeries, adjustments, or if complications arise.
What regulatory pathway was followed for FDA clearance of the Darco Small Screw, and what does this mean for its classification?
The Darco Small Screw received FDA clearance through the Traditional 510(k) pathway, specifically under the Orthopedic (OR) Advisory Committee, and was determined to be Substantially Equivalent (SESE) to a predicate device. This places it in Class II regulatory classification, indicating it poses moderate risk and requires compliance with specific controls to ensure safety and effectiveness.