Pace Surgical Receives FDA 510(k) Clearance for Screw System

Pace Surgical announced FDA has granted 510(k) clearance for its Ultra Compression Screw System, indicated for the internal fixation and stabilization of arthrodesis, osteotomies, fractures, and nonunion of the foot and ankle.

The Ultra Compression Screw System introduces a patent-pending approach to mechanical compression and fixation, addressing longstanding challenges in achieving consistent bone apposition and stable union across a variety of anatomic sites. Its design delivers predictable compression, high pull-out strength, and consistent torque upon insertion as a new standard for forefoot, midfoot, and hindfoot applications.

The Ultra Compression Screw System features a self-starting tip geometry and thread form that or optimizes bone engagement, and reduced stripping, and allows for consistent torque through varying bone quality and densities. The company plans a limited release of the Ultra Compression Screw System in select surgical centers, followed by a broader commercial rollout later in 2026 of Pace’s full reconstruction offering, to include anatomical locking plates and screws.

Pace Surgical operates within Runway Healthcare, a MedTech venture studio that develops and scales breakthrough technologies in Orthopedics, Trauma, and Spine through a focused, capital-efficient model.

“Surgeons know that reliable compression and ease of use determine success in foot and ankle reconstruction,” said Bill Rhoda, Chief Technology Officer of Pace Surgical and General Partner of Runway Healthcare. “The Ultra Compression Screw System was engineered in direct collaboration with surgeons to provide reproducible results and tactile feedback, and to restore anatomical constructs with purpose-built solutions. This clearance accelerates our plans to bring a differentiated solution to a growing procedural market.”

Source: Pace Surgical