Orthopedic Innovations: FDA Clearance and New Frontiers in Surgical Devices

Toetal Solution’s Ziptoe Hammertoe System received FDA 510(k) clearance, offering a preloaded titanium–nitinol intramedullary implant and a single-use surgical kit designed to streamline implant handling, alignment control, and procedural setup for proximal interphalangeal joint (PIPJ) arthrodesis.

PIPJ arthrodesis typically involves resecting joint surfaces, preparing bone canals, and using intramedullary or small-plate fixation to achieve rigid fusion with correct toe length and alignment. Precise alignment and consistent fixation are essential to clinical success, yet surgeons commonly cite challenges in tight soft-tissue envelopes, reproducible alignment across cases, and intraoperative fixation consistency. The Ziptoe design directly targets these routine procedural hurdles by simplifying implant delivery and alignment control.

The system’s core features—reported by the company—are a pre-loaded intramedullary implant made of titanium and nitinol and a sterile, single-use surgical kit that integrates delivery instruments. That packaged workflow aims to reduce instrument handling and operating-room setup time while providing consistent implant placement.

FDA 510(k) clearance means the Ziptoe System has been reviewed as substantially equivalent to a legally marketed predicate device, enabling U.S. market entry and reducing regulatory uncertainty for hospitals and commercial partners. Clearance is not evidence of clinical superiority, but it lowers regulatory barriers, can accelerate commercialization timelines, and functions as a practical enabler for limited market activity, due diligence by potential acquirers or distributors, and early clinical familiarization.

With regulatory clearance and the system’s reported design features, surgeons gain an additional option that may streamline implant handling and alignment control for PIPJ arthrodesis. Practical uptake and comparative value in hammertoe correction will hinge on real-world experience, surgeon feedback, and postmarket data.

Key Takeaways:

• The Ziptoe System pairs a pre-loaded titanium–nitinol intramedullary implant with a disposable surgical kit and now has FDA 510(k) clearance, presenting a packaged workflow option for PIPJ arthrodesis that may simplify intraoperative handling.
• Foot and ankle surgeons who perform hammertoe correction—and the hospitals that support those procedures—are the primary audiences; operative teams may see fewer instrument-handling steps and more consistent implant delivery.
• Near-term activity will likely focus on limited commercial engagement, clinical familiarization, and targeted use; broader adoption depends on real-world experience and the vendor’s commercial rollout.