Graft Delivery Device with Integrated Stylet
by Micromedics, Inc. (D/B/A Nordson Medical)
510(k) K151543
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK151543 | Date7 Jul 2015 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- FMF
- Device Class
- Class II
- Regulation
- 21 CFR Part 880.5860
- Advisory Committee
- General Hospital
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
This device is a Graft Delivery Device (Product Code: FMF) designed to facilitate the precise placement of hydrated allograft, autograft, or synthetic bone graft material during orthopedic surgical procedures. It integrates a stylet to enhance controlled delivery, ensuring accurate positioning of graft material at the surgical site.
The Graft Delivery Device with Integrated Stylet is supplied as a sterile, single-use, disposable device. It is intended for use in general hospital settings and has received FDA 510(k) clearance under Special Review (K151543). No additional regulatory markings or indications are specified beyond its intended orthopedic application.
Other devices from Micromedics, Inc. (D/B/A Nordson Medical)
Questions
AI-generated answers, 19 Sep 2026
What types of bone graft materials can be delivered using this device, and why is this important for surgical precision?
This device is designed to deliver hydrated allograft, autograft, or synthetic bone graft materials during orthopedic procedures. The integration of a stylet ensures controlled and precise placement of the graft, which is critical for achieving accurate positioning at the surgical site and optimizing healing outcomes.
Is this device meant for reuse in multiple surgeries, or is it intended for single-use only? How does this impact its sterility?
The Graft Delivery Device with Integrated Stylet is explicitly supplied as a sterile, single-use, disposable device. This design ensures patient safety by preventing cross-contamination between procedures, as reuse could compromise sterility and introduce infection risks.
Where is this device primarily intended for use, and what kind of surgical environment should expect to encounter it?
The device is intended for general hospital settings, specifically within orthopedic surgical environments where bone graft placement is required. Its design aligns with procedures performed in operating rooms equipped for orthopedic interventions.
How does the integrated stylet improve the functionality of this device compared to traditional graft delivery methods?
The integrated stylet enhances controlled delivery by providing a guided pathway for the graft material, reducing the risk of misplacement or fragmentation during insertion. This improves precision, which is particularly valuable in complex orthopedic reconstructions where graft positioning directly impacts surgical success.
What does the FDA’s Special Review (K151543) designation mean for this device’s regulatory pathway, and how does it affect its availability?
The Special Review designation indicates that the FDA conducted an additional level of scrutiny beyond standard review for this 510(k) clearance, ensuring thorough evaluation of its safety and effectiveness. This process does not alter the device’s availability but confirms its compliance with regulatory standards for orthopedic graft delivery systems in the U.S. market.