Medline Cannulated Screw
510(k) K130319
Active
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK130319 | Date31 May 2013 | StatusActive |
Official records
- FDA 510(k) database K130319
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
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
Overview
AI-generated summary, 1 Oct 2026
The Medline Cannulated Screw is a bone fixation device classified as an orthopedic screw under the FDA’s product code HWC. It features a hollow, cannulated design for improved insertion techniques, allowing for minimal tissue disruption and precise placement within bone. These screws are self-drilling and self-tapping, reducing the need for additional instrumentation during surgical procedures. Their reverse-cutting threads enhance grip and stability, making them suitable for orthopedic applications requiring secure fixation.
The Medline Cannulated Screw is supplied as a single-use, non-sterile device intended for surgical use after sterilization by the healthcare provider. It is available in sizes referenced by the product code HWC and is regulated under the FDA’s 510(k) clearance process, classified as substantially equivalent to a predicate device. The device is designed for use in orthopedic procedures, including foot and ankle surgeries, and must be sterilized prior to implantation. No specific MRI safety information is provided in the regulatory data.