The FDA granted Spinal Resources 510(k) clearance for the Swedge Pedicle Screw System.
Here are five things to know:
1. Spinal Resources previously focused on spinal implant design and distribution, but this FDA clearance marks the company's transition into full product manufacturers.
2. The implant system is designed to reduce inventory and increase surgical procedure options.
3. Spinal Resources is known for systems that accommodate multiple rods in a single-screw tulip with single-locking cap to lock the tulip's angle in place. The system is cleared for 5.5 mm rods currently, while the 4.75 mm and 5 mm rods are pending clearance.
4. The system allows for greater versatility in preplanning and interoperative stages. Surgeons don't have to fiddle with the system because the rods and screws can easily transition between diameters and lengths. The company hopes the implant system will ultimately shorten operating room time and lower costs.
5. Spinal Resources is exploring full commercialization options of the Swedge system.