Nextremity Solutions, Inc. Announces 510(k) Clearance of the StealthFix™ Intraosseous Fixation System
Improvements made to upcoming StealthFix System
WARSAW, IND. (PRWEB) APRIL 21, 2022
Nextremity Solutions, Inc., a Strategic Commercialization Organization (SCO) with a focus on the extremity musculoskeletal space, located in “The Orthopedic Capital of the World,” Warsaw, Ind., announced that it has received a new 510(k) FDA clearance of its StealthFix intraosseous fixation platform; a novel fixation platform for use in both upper and lower extremities.
The original technology, which had previously received 510(k) clearance was obtained by Nextremity through a technology acquisition. Once the technology was obtained by Nextremity, the product development team decided that improvements were necessary based on the feedback of the surgeon development team assigned to the project. The improvements made resulted in the need for a new submission.
Ryan Schlotterback, Chief Technology Officer for Nextremity Solutions, commented, “While no one likes to delay the launch of a product, we remain steadfast in our commitment to the development of surgeon-driven technologies. This can sometimes mean that, to commercialize a product that surgeons will use in the treatment of their patients, you must make necessary changes to the product line. We believe that the improvements we’ve made to this system will provide surgeons with an innovative solution that truly meets their needs.”
StealthFix is an intraosseous small bone fixation system for the treatment of arthrodesis, osteotomies, and bone fractures in the foot or hand. Devices that are currently used in the treatment of these indications are bone plates, staples, and screws. The majority of these treatment options are placed on bone. The prominence of these devices has been reported to cause soft tissue irritation, as well as pain in some patients. This can lead to removal of the hardware in a subsequent surgery. Intraosseous solutions, such as the StealthFix, are completely implanted within the bone, minimizing complications due to hardware prominence.
StealthFix is indicated for fixation of bone fractures, fusions, or for bone reconstructions, including arthrodesis in hand or foot surgery, mono or bi-cortical osteotomies in the foot or hand, fracture management in the foot or hand, distal or proximal metatarsal or metacarpal osteotomies, as well as fixation of osteotomies for hallux valgus treatment such as scarf, chevron, etc.
About Nextremity Solutions, Inc.
Nextremity Solutions, Inc. is a privately held Strategic Commercialization Organization (SCO) with a focus on lower and upper extremity, trauma, sports medicine, and joint preservation, offering innovative solutions and Revenue Ready® products for various extremity musculoskeletal applications and for the benefit of our industry partners. The Company’s procedure-ready, sterile implant systems include uniquely precise, proprietary technology designed to achieve repeatable and superior clinical outcomes.
