MatrixRIB Fixation System
by Synthes (USA) Products, LLC 510(k)
Active
510(k) K133616
Overview
The MatrixRIB Fixation System is an orthopedic device classified as a rib fixation system for surgical stabilization of the chest wall. It provides secure fixation of ribs, sternum, and osteotomies in both normal and osteoporotic bone, ensuring structural integrity during healing. The system includes locking plates and screws designed to maintain alignment and promote proper bone union. Its primary function is to address fractures, fusions, and reconstructions of the rib cage and sternum, enhancing patient recovery through mechanical support.
This system is supplied as a reusable surgical implant composed of commercially pure titanium (Grade 4) and titanium alloy (Ti-6Al-7Nb) components, including straight plates, I-plates, T-plates, and locking screws. It is intended for use in sterile operating room environments by orthopedic surgeons, with applications in open or minimally invasive procedures. The device is regulated under FDA 510(k) clearance (K133616) as a substantially equivalent orthopedic fixation product, adhering to traditional review pathways. No single-use or MRI safety classifications are specified in the available data.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK133616 | Date2 May 2014 | 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- Withdrawn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
- HRS
- Device Class
- Class II
- Regulation
- 21 CFR Part 888.3030
- Advisory Committee
- Orthopedic
- FDA Decision
- SESE Substantially Equivalent
Other devices from Synthes (USA) Products LLC
Questions
What types of surgical procedures is the MatrixRIB Fixation System designed to support in the chest wall or rib cage?
The MatrixRIB Fixation System is specifically designed to stabilize the chest wall during surgical procedures involving rib fractures, rib cage fusions, or reconstructions, including sternal stabilization. It provides mechanical support to maintain alignment and promote proper bone healing in both normal and osteoporotic bone, ensuring structural integrity during recovery. This system is suitable for use in open or minimally invasive surgeries by orthopedic surgeons.
Is the MatrixRIB Fixation System intended for single-use or can it be reused in multiple procedures?
The MatrixRIB Fixation System is explicitly described as a reusable surgical implant. It is made from commercially pure titanium (Grade 4) and titanium alloy (Ti-6Al-7Nb), which are materials commonly used for durable, long-lasting medical devices. Reusability is a key design feature, allowing for sterilization and repeated use in sterile operating room environments.
What materials are the components of the MatrixRIB Fixation System made from, and how does this affect its performance?
The MatrixRIB Fixation System components—including plates (straight, I-plates, T-plates) and locking screws—are manufactured from commercially pure titanium (Grade 4) and titanium alloy (Ti-6Al-7Nb). These materials provide a balance of strength, corrosion resistance, and biocompatibility, ensuring secure fixation in both normal and osteoporotic bone while minimizing the risk of adverse reactions during long-term healing.
What sizes or configurations of plates and screws are available in the MatrixRIB Fixation System?
While the exact sizes or configurations (e.g., plate lengths, screw diameters) are not detailed in the provided data, the system includes straight plates, I-plates, and T-plates, along with locking screws, to accommodate various anatomical requirements for rib, sternum, and osteotomy fixation. The modular design allows for customization to address specific surgical needs in chest wall stabilization.
How should the MatrixRIB Fixation System be stored to maintain its integrity before use?
Since the MatrixRIB Fixation System is reusable and intended for sterile operating room environments, it must be stored in a way that preserves its cleanliness and structural integrity. Proper storage typically involves keeping components in a sealed, sterile packaging or a dedicated instrument tray until sterilization (e.g., autoclaving or ethylene oxide) before surgical use. The manufacturer’s guidelines—though not explicitly detailed here—would outline specific storage protocols to prevent contamination or damage.