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In our latest FDA 510(k) recap, we highlight companies that received their first orthopedic clearances this year in the spinal fixation and trauma segments. BoxSpine introduces a spinal stabilization solution, SpinePoint addresses the difference in stiffness between implant and bone, Chest Wall Innovations focuses on rib fracture fixation, and Reselute and Satori Orthopaedics offer new nails for tibial fractures.
Spine
BoxSpine | DUET Spinal Fixation System, K253169
Submitted September 2025, granted February 2026
Primary predicate: Benvenue Medical Trivergent Spinal Fixation System, K201427
FYI: DUET is a three-piece spinal stabilization system designed to eliminate the need for traditional rods. A halo device captures a spherical implant head, creating 360° contact and allowing 35° to 60° of articulation, depending on patient anatomy. The components are secured with a locking cap that engages directly with the implant. The DUET platform is streamlined, with minimal SKUs and a disposable, single-use sterile instrument kit.
Formed in 2021, BoxSpine works with technology providers to bring advanced tools, including spinal navigation systems, directly to ASCs. Leadership has held past roles at numerous distributorships, as well as PathKeeper, SpineCraft, SpineGuard and WishBone Medical.
SpinePoint | Flex-Z Cervical Cage, K252432
Submitted August 2025, granted March 2026
Primary predicate: NuVasive Modulus-C Interbody System, K223731
FYI: This cage is designed to address the stiffness mismatch between conventional interbody implants and vertebral bone. Through a 3D-printed porous titanium architecture and a patented Z shape to allow for cushioning, Flex-Z is engineered to provide ultra-low stiffness approaching that of cancellous bone, while maintaining the structural integrity and durability required for spinal surgery.
The Flex-Z Cervical Cage is the SpinePoint’s first cleared product in a planned platform of eight interbody devices spanning cervical, lumbar and lateral approaches.
This surgeon-founded company was established in 2017, and is located in Reno, Nevada.
Trauma
Chest Wall Innovations | PC Fix System, K260411
Submitted February 2026, granted April 2026
Primary predicate: Zimmer Biomet RibFix Advantage System, K203474
FYI: PC Fix comprises titanium and PEEK rib plates and a post-and-cap fixation construct, and is indicated for the fixation, stabilization and fusion of rib fractures and osteotomies of normal and osteoporotic bone. The system is reported to be the only of its kind to offer both PEEK and titanium implants capable of supporting intrathoracic and extrathoracic surgical approaches, giving surgeons versatility in treating patients with traumatic rib fractures.
Chest Wall Innovations was formed in 2024 in Hershey, Pennsylvania. The company’s leadership has served in roles at Mitek Sports Medical/Synthes, SIG Medical (acquired by Zimmer Biomet in 2019), Trice Medical and Zimmer Biomet.
Reselute | Reselute Tibial Nail, K253517
Submitted November 2025, granted March 2026
Primary predicate: GPC Medical Intramedullary Nailing Systems, K143245
FYI: The nail is intended to stabilize fractures of the proximal and distal tibia and the tibial shaft, open and closed tibial shaft fractures, certain pre- and post-isthmic fractures and tibial malunions and non-unions.
In 2025, the company was awarded a NIH FastTrack SBIR combined Phase I/II grant. The nondilutive funding will support ongoing R&D for the Reselution Intramedullary System in expanded indications for orthopedic infection solutions. Further, the Reselution Tibial Intramedullary Fixation System has received FDA’s Breakthrough Device Designation.
Established in 2022 and headquartered in Durham, North Carolina, Reselute is developing solutions for the treatment of orthopedic-related infections. Leadership brings experience from roles at MedShape Solutions, restor3d, Vertera Spine and service on numerous boards.
Satori Orthopaedics | Active Intramedullary (AIM) Tibial Nail, K252025
Submitted June 2025, granted March 2026
Primary predicate: Orthoxel Apex Tibial Nailing System, K170972
FYI: This tibial intramedullary fixation rod is designed to be implanted proximally and distally to a fracture line. The system comprises an intramedullary nail and interlocking screws. The intramedullary nail is made from titanium alloy and includes an internal compression spring for compression force/axial movement.
Satori was founded by a surgeon in 2022 and is based in Phoenix, Arizona.
