Leucadia MIS Pedicle Screw System
by Phygen, LLC
510(k) K112931
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK112931 | Date2 Nov 2011 | 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- Withdrawn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
- Full name
- Leucadia(Tm) Mis Pedicle Screw System
- 510(k) Number
- FDA Product Code
- NKB
- Device Class
- Class II
- Regulation
- 21 CFR Part 888.3070
- Advisory Committee
- Orthopedic
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Leucadia MIS Pedicle Screw System is a minimally invasive orthopedic device designed for spinal fixation. It consists of pedicle screws and associated hardware intended to provide correction, immobilization, and stabilization of spinal segments in the thoracic, lumbar, and sacral regions as an adjunct to spinal fusion procedures.
This system is supplied sterile and intended for single-use in posterior, non-cervical spinal fixation. It is regulated under FDA 510(k) clearance (K112931) and is classified under product code NKB. The device is intended for use in orthopedic surgical settings and adheres to minimally invasive surgical (MIS) techniques.
Other devices from Phygen, LLC
Questions
AI-generated answers, 1 Oct 2026
What is the Leucadia MIS Pedicle Screw System used for?
The Leucadia MIS Pedicle Screw System is designed for spinal fixation in minimally invasive orthopedic procedures. It provides correction, immobilization, and stabilization of spinal segments in the thoracic, lumbar, and sacral regions as an adjunct to spinal fusion. This system is specifically intended for posterior, non-cervical applications, ensuring targeted support where traditional open surgery may be less accessible.
How is the Leucadia MIS Pedicle Screw System supplied and what does this mean for clinical use?
The system is supplied sterile, which eliminates the need for additional sterilization steps in the operating room. This ensures immediate readiness for use and reduces the risk of contamination. As it is intended for single-use, each component is designed for one surgical procedure only, promoting patient safety and hygiene by preventing cross-contamination between patients.
Is this system suitable for all spinal regions, and if not, which regions are supported?
No, the Leucadia MIS Pedicle Screw System is not designed for cervical spine applications. Instead, it is specifically approved for use in the thoracic, lumbar, and sacral regions. This targeted design allows for precise stabilization in these areas, where minimally invasive techniques are particularly advantageous for reducing surgical trauma and recovery time.
What regulatory pathway does the Leucadia MIS Pedicle Screw System follow, and what does this imply for clinicians?
The system follows the FDA 510(k) clearance pathway, with a clearance number of K112931. This indicates that the device has been deemed substantially equivalent to a legally marketed predicate device, meaning it meets established safety and performance standards. Clinicians can rely on this regulatory clearance as assurance of the system’s compliance with FDA requirements for spinal fixation hardware, though they should always refer to the full labeling for specific surgical guidelines.
How does the minimally invasive approach of this system benefit patients compared to traditional open surgery?
The minimally invasive design of the Leucadia system reduces tissue disruption, leading to less postoperative pain, shorter hospital stays, and faster recovery times compared to traditional open surgery. By using smaller incisions and specialized instrumentation, the system targets the spine with precision while minimizing damage to surrounding muscles and soft tissues, which can significantly improve patient outcomes and overall satisfaction.