The Memo: CustomSurg Turning Scans Into Plans for Complex Fracture Care

Under the direction of Co-Founder and Co-CEO Valentin Christian Splett, CustomSurg is redefining orthopedic trauma care with a first-of-its-kind digital platform that turns complex fracture imaging into precise, personalized surgical plans. By combining AI, simulation, and clinical expertise, CustomSurg supports surgeons with objective, data-driven guidance to reduce variability, improve outcomes, and address a critical global shortage of experienced trauma specialists.

Origin Story

CustomSurg was born from a close friendship and a shared desire to solve a recurring problem in the OR. Splett, a serial entrepreneur, co-founded the company alongside trauma surgeon Dr. Arvind von Keudell MD PhD MPH and biomedical engineer Thomas Zumbrunn. “Arvind would meet us after work and talk about how in trauma surgery, he had really big challenges in the operating room,” said Splett. “He’d say, ‘It’s just so hard to piece these fractures back together…it’s like repairing a broken vase in the dark.’”

Zumbrunn, a biomechanics expert, envisioned a future where technology could “flip the light switch” for surgeons by offering an objective view of complex fractures. That idea eventually evolved into CustomSurg, incorporated in 2021 following foundational research and a successful clinical proof of concept. Today, the company blends their clinical, technical, and commercial expertise into a singular mission: make complex fracture surgery simpler, better, and faster.

The Current Landscape

Approximately 30 million patients a year suffer from a complex fracture, costing up to $100,000 each. Articular fractures represent one of the most technically demanding categories in orthopedics. These injuries require significant expertise, often 5+ years of additional training, and even then, complication rates exceed 30%. “Every fracture is different. Every patient is different,” said Splett. “We want to help surgeons perform at their best, even if they haven’t done 100 of these surgeries before.”

Despite the high unmet need, current solutions rely heavily on subjective experience and trial-and-error. Meanwhile, surgeon shortages are growing, and fracture incidence is rising. With a U.S.-first market strategy and traction among Tier 1 hospitals, CustomSurg is positioning itself as essential infrastructure for trauma centers navigating these dual pressures.

Inside the Innovation

CustomSurg takes imaging data from a CT scan and transforms it into a step-by-step surgical plan using AI and computational modeling. The CustomSurg platform guides trauma surgeons through a seamless “scan-to-plan” process that includes:

• Segmentation: Turning CT slices into volumetric meshes

• Alignment: Solving the fracture puzzle anatomically

• Calibration: Assigning material properties and planning hardware placement

• Simulation: Applying real-world load scenarios

• Output: Sending the optimal surgical plan to the surgeon’s smartphone

“We’re the first company in orthopedics to use simulation for treatment rather than just research,” said Splett. 

The solution, built on years of research and exclusively licensed IP from Harvard and ETH Zurich, has reached design freeze. The first 510(k) submission has completed third-party review and is now pending FDA approval. A second submission, covering CustomSurg’s patient-specific bone fracture reconstruction technology, recently received Breakthrough Device Designation.

Progress and Milestones

CustomSurg’s progress reflects its rapid advancement from concept to commercialization, with milestones that underscore both clinical validation and market readiness:

• $5M in funding to date, with a $15M Series A round in progress to support U.S. market entry

• FDA Breakthrough Device Designation for its patient-specific bone fracture reconstruction technology

• First 510(k) submission completed, with approval expected imminently

• Patent granted

• Two registered trademarks

• IRB approval for a first-in-human clinical trial at Massachusetts General Hospital and Brigham and Women’s Hospital

• Five signed industry partnerships, including agreements with implant manufacturers

• 100+ surgeons on the platform’s waitlist, with 25 Level 1 trauma centers in the sales pipeline

Feedback from the clinical community has been overwhelmingly positive. “We’ve heard it called the Holy Grail. Some say, ‘I want it tomorrow,’” said Splett. “The only pushback we get is from a small fraction of older surgeons who believe their experience is enough. But that’s the exception, not the rule.”

Join Us at LSI Europe ‘25

• Splett has been selected to present at LSI Europe ’25 (September 7–11) in front of hundreds of global medical technology companies. Join us in welcoming him to the event in London, where he will share the latest updates on CustomSurg’s technology and development.