Each year, the July/August issue of ODT focuses on the highest revenue-producing companies within the orthopedic device sector. These same companies also enjoy the most attention when it comes to news coverage throughout the remainder of the year. As such, the editorial team takes an opportunity to recognize several noteworthy organizations that are either just starting within the industry or chasing the leading firms. This showcase presents six companies that offer a unique innovation that has caught the eye.

Scalpel AI & Canary Medical

Sean Fenske • Editor-in-Chief

Orthopedics is still commonly thought of by the mainstream as solid metal implants and invasive surgeries that come with long recovery times. Fortunately, many manufacturers within the sector—both large and small, established and startup—are working to change this viewpoint. One of the ways the industry is transforming is with the influx of intelligence. Smart technologies, data, artificial intelligence (AI), additive manufacturing, and a variety of materials (e.g., metals, ceramics, and plastics) are all being leveraged for the new generation of innovations that will be used to treat issues with bones, muscles, and tissue. Following are two companies that have embraced advanced technologies to improve upon traditional orthopedic devices and processes. 

Second Set of Eyes

During a procedure is the worst time for the surgeon to discover an instrument is missing, broken, contaminated, or suffers from another problem. A nurse or assistant shouldn’t have to run to another tray to attempt to find a replacement. When the patient is on the table and the surgery is taking place, the focus should be solely on what’s happening in that sterile environment, not on replacing a necessary tool. 

Scalpel AI has developed technology to help eliminate this issue while also resolving other challenges associated with instrument sets. The sophisticated computer vision platform can be used at many steps along the journey of an instrument tray. For device companies, the system enhances the tray packing process and eliminates errors. Within sterilization centers and facilities, Scalpel AI can help ensure accuracy, increase speed, and verify safety in the validation and preparation of the tray. Finally, for the OR, the system can maintain inventory and usage of the instruments while also optimizing the tray. 

Also, since the system is vision-based, it does not require the use of third-party tags, labels, or some other method of identification. The computer vision system generates a digital twin of every instrument, which it leverages to verify surgical trays have the correct tools within.

Yeshwanth Pulijala, Ph.D., (in medical visualization) founded the company after having first-hand experience in seeing how instrument mismanagement could adversely impact patient safety. 

“At Scalpel AI, we work with leading medical device companies and healthcare organizations to transform their logistical supply chain and reduce costs by millions of dollars,” explained Dr. Pulijala. “Together, we are making surgery safer for patients while paving the way for personalized surgery, which we believe is the future of healthcare.”

In October 2024, the company successfully raised approximately $4.8 million in a funding round led by Mercia Ventures, with participation from Tensor Ventures and private investors. The company planned to scale its operations and roll out the technology to leading organizations within the healthcare supply chain.

Brain Stem

The concept of smart orthopedic implants goes back several decades as the future of orthopedics. However, that promise never seemed to materialize for a variety of reasons—the technology wasn’t available to make it possible, the benefits didn’t warrant it, and the reimbursement for the additional features wasn’t available. However, Canary Medical’s Dr. Bill Hunter thought differently. 

“After almost a decade of development and designation by FDA as a Breakthrough Device, we’re proud that our CANARY canturio te technology has enabled Zimmer Biomet to debut the world’s first smart knee implant. Persona IQ reflects our shared belief that automatic, reliable, and accurate data collection and analysis represents the future of orthopedic care,” Dr. Hunter, the company’s CEO, said in a 2021 announcement of the implant’s De Novo classification grant. “The launch of Persona IQ marks the start of an exciting, ongoing partnership with Zimmer Biomet designed to innovate smart implant technologies that help joint replacement patients regain and maintain their mobility with confidence.”

The innovation powering the Persona IQ implant is Canary’s canturio te, which leverages materials and technologies found in pacemakers. In 2021, the battery had a 10-year lifetime, but that’s been increased since, eliminating the need for replacement due to loss of power. The unit is tucked within the implant’s tibial extension, where it passively collects data without requiring action by the patient. 

The innovation was licensed to Zimmer Biomet for its implant via an exclusive agreement. The company is reported to be looking to add the intelligent solution to a shoulder and hip implant as well. 

Canary Medical, however, is also seeking to leverage the technology in other ways, outside of its agreement with Zimmer Biomet. One application area is to develop a version for the spine. It would involve the technology being leveraged as part of an interbody cage with a partner. 

Another project, outside of the orthopedics sector, has the organization innovating a cardiac monitor. For that mission, the company is embarking on its own and will examine the organ’s physiology. 

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restor3d & Spineology

Sam Brusco • Associate Editor

Who doesn’t love a bespoke fit? Wearing something tailored specifically to your body is comfortable, stylish, and well worth the extra money.

The same holds true for an orthopedic implant. If an artificial knee is customized to fit, chances are it will function more naturally than a “one-size-fits-all” option. Orthopedic implant makers are latching on to this notion more than ever, creating custom implants in the planning stages before surgery.

The two companies I selected have made it their specific missions to create the best fit in orthopedic and spine surgeries. This way, patients can benefit from implants that truly complement their bodies.

Personal Best

Restor3d’s mission is that every patient deserves personalized care, which the company accomplishes through patient-specific, 3D-printed musculoskeletal implants. The company has expertise in 3D printing of osseointegrative materials, AI-based planning and design automation tools, and digital health solutions.

All of the company’s design work is done in-house with the help of design automation, as well as most of its manufacturing. Its r3id personalized surgery platform is a digital tool to help surgeons create a patient-specific planning experience. 

At restor3d’s core is TIDAL technology, which is additively manufactured via laser powder bed fusion of medical grade titanium or cobalt-chrome alloys. It’s designed for repetitive load-bearing, boasting load distribution through gyroid lattices that exhibit higher strength than truss-based lattices. High surface area and microscopic surface roughness encourage wicking across the surface, and continuous curvature facilitates fusion in preclinical critical-sized bone defects.

In July 2021, the company merged with total ankle replacement company Kinos Medical, marking its expansion into the U.S. foot and ankle market. restor3d nabbed FDA clearance for its patient-specific resection system for the Axiom total ankle in April 2023—the product was the first FDA-cleared all-metal, patient-specific arthroplasty instrument system.

Two months later, the company revealed it was acquiring personalized orthopedic implant firm Conformis for $2.27 per share. The acquisition was completed in September 2023, adding personalized knee and hip implants to its portfolio. In August 2024, restor3d moved into the field of robotics and navigation by appointing a Senior VP of Robotics and Senior VP of Hip & Knee. The company hopes to integrate the enabling technologies with its existing 3D-printed, patient-specific implants and instruments.

An FDA nod for the Ossera AFX ankle fusion system followed in March 2025. The system features the company’s 3D printing and TIDAL technology and is engineered for optimized osseointegration and biomechanical stability. FDA clearance for the iTotal Identity CR 3DP porous total knee followed a month later—the cementless system combines patient-matched design with advanced 3D-printed porous technology. The company also raised $38 million in growth capital that month to launch four new product lines over the next two years: the Veritas shoulder, iTotal Identity knee, Kinos ankle, and Velora hip cup.

Personal Space

Serial entrepreneur Dr. Stephen Kuslich had already greatly impacted the spine market by co-developing the BAK spinal fusion cage. After thousands of discectomies and decompressions, he sought a solution to accomplish surgical goals and deliver a larger implant through a smaller incision. He resolved to find a solution to restoring disc height that would significantly decrease access to the spine. After various iterations, he was still challenged to contain the bone graft in this new implant form.

Over lunch, Dr. Kuslich noticed his development partner holding a hacky sack in his knit-gloved hand. As he watched the nature of this toy, he knew—the bone material alone, if contained properly, could provide the needed structural strength to support fusion. They went back to the lab and morselized a bone from the previous day’s lunch. They just needed a way to contain the bone graft. Dr. Kuslich cut off a finger of his partner’s glove and filled it with the bone material, and the rest was history.

Patent work on the flagship OptiMesh implant began in 1993, and Spineology was founded in 1997. The implant gained FDA clearance for vertebral body defects in 2003, and the first clinical cases commenced a year later.

OptiMesh’s “Conform and Expand” technology provides a custom anatomical fit for lumbar fusion surgical patients. Its powerful distraction forces and conformance to the endplates provide strength and stability to restore disc height, achieve alignment goals, and promote a robust fusion.

The company began efforts to obtain a De Novo and investigational device exemption (IDE) grant for OptiMesh in 2013. The De Novo approval was granted in 2020. OptiMesh expands in three dimensions, letting surgeons perform interbody fusions through the smallest access in the spine industry, the company claims.

The next-gen OptiMesh 2.0 launched in 2021, followed by the OptiLIF Endo procedure in 2023. The procedure integrates spine endoscopy into the OptiLIF procedure without adding further steps. Using it, surgeons can directly visualize the disc space, neural structures, and bony anatomy throughout the procedures.

A leadership change materialized at the end of 2023. John Booth retired from his role as CEO and former Alphatec Spine Executive VP Brian Snider took the helm.

OptiMesh Align hit the shelves in June of this year. The biologics-based solution is used for real-time, in-situ, independent anterior and posterior implant expansion that results in a customized, patient-specific lordotic shape up to 20 degrees.

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Polaris^AR & Surgical Planning Associates Inc. 

Michael Barbella • Managing Editor

There’s no turning back. 

In surgery, each incision is permanent. Every choice carries weight—and cannot be undone.

An atmosphere of finality looms over the operating room like an ominous storm cloud, waiting to unleash its fury. H. John Cooper, M.D., has felt the weight of that irrevocability during his countless hours in the OR, where every procedure is a one-way path without return. 

The burden is especially heavy for procedures like total knee arthroplasty, as precise bone resections are critical to ensure proper implant alignment and fit. “In total knee arthroplasty, once an orthopedic surgeon has performed resections to the patient’s bone, turning back is not a viable option,” Dr. Cooper, an orthopedic surgeon and associate professor of orthopedic surgery at Columbia University Irving Medical Center, wrote in an exclusive ODT feature last year. “While resections can be modified by resecting additional bone, they cannot be undone. That sense of finality is always with me in the OR, and it has often made me wish I could peer at the patient’s individual anatomy prior to picking up the saw to confirm the accuracy of my planned resections.”

Dr. Cooper no longer has to wish for such peeping prowess. Cutting-edge medical innovations have turned his long-held wish into a tangible, living reality, thanks to mixed reality technology. 

Merging the real and virtual worlds, mixed reality (MR) superimposes virtual 3D images into real-world environments, providing participants with a truly immersive experience. Over the last decade, MR has become an increasingly popular surgical planning tool; studies suggest the technology can help improve visualization and collaboration for physicians, and improved surgical precision, which ultimately can foster better patient outcomes. As Dr. Cooper stated in his exclusive: “…the emergence of this technology [is] a milestone moment for orthopedic surgery one with the potential to shift the standard of care for experts across our field.”

Simply STELLAR 

Paul Mikus’ company is capitalizing on the robotic-assisted surgery trend in orthopedics—without a robot. Tapping into the industry’s shift toward simpler, smaller robotic systems compatible with any implant, the Miami startup is applying the same approach to its mixed reality technology. 

Mikus’ nearly five-year-old firm, Polaris^AR, claims to be pioneering a new era in surgical technology by “expanding the boundaries of traditional methods but also redefining the essence of surgical precision and patient care.” Its flagship product, the STELLAR Knee, delivers the same benefits as traditional total joint robotic systems, but through a mixed reality platform.

Approved by the U.S. Food and Drug Administration in November 2023, the STELLAR Knee leverages advanced visual display technology to combine real-time (physical) surgery and virtual surgical guidance to create a digital OR environment. STELLAR Knee acts as a spatial computer, according to the company, creating a continuous data exchange between surgeon and software. 

Contained within a highly portable MR headset, the software captures patient-specific anatomical data in real time, giving surgeons on-demand access to critical information throughout the entire total knee arthroplasty (TKA) procedure. The tool offers real-time adjustment capabilities without the footprint or more cumbersome aspects of predicate technologies. 

Surgeons rely on STELLAR Knee to measure, plan, and navigate the entire procedure using intuitive hand gestures and voice commands. The solution is simple to set up and integrate, and can be paired with any total knee replacement implant system.

Study data show STELLAR Knee achieves sub-millimeter, sub-degree average errors in bone resections, indicating high precision compared to modern robotic-assisted TKA systems

“Mixed reality is an opportunity to provide robotic-like accuracy agnostic to implant without the cost or footprint of that technology,” Mikus told LSI USA ’25 attendees earlier this year. “[It] makes [for] a compelling business case and really a limitless opportunity from a data-driven solution approach into the marketplace.”

Hips In Sight

Toni Clapp is a living testament to the marvels of modern medical ingenuity.

Born with severe Developmental Dysplasia of the Hip (neither joint in its socket), Clapp has undergone numerous replacement procedures throughout her lifetime. Accordingly, she’s experienced firsthand the evolving technology that has helped restore her hips to proper alignment.

Clapp sampled the latest advancement before her most recent surgery, catching a glimpse of her defective anatomy via 3D imaging and a better understanding of her doctors’ repair plan. “Because of the technology,” Clapp said in an online video, “I know that my outcome is going to be excellent.”

Clapp gained that insight from HipInsight, the world’s first mixed reality-based digital platform for total hip arthroplasty. Developed by Boston-based Surgical Planning Associates Inc., the HipInsight system provides surgeons with “X-ray vision,” enabling them to see three-dimensional images of a patient’s anatomy and planned hip component placement during the procedure. 

HipInsight has been used to repair more than 3,000 diseased and damaged hips since its FDA clearance in January 2021. Marketed by Zimmer Biomet for the last three years, the system’s second-generation version won FDA authorization last summer. 

HipInsight 2.0 enables a newly patented method of overlaying digital content onto the patient, making workflow more wide-ranging, seamless, and applicable to any surgical technique. Traditionally, surgeons must perform a 3D procedure based on two-dimensional X-ray planning and often intraoperative X-ray assessment. The HipInsight system projects three-dimensional data onto mixed-reality eyeglass lenses, giving surgeons more intuitive insight and allowing them to focus entirely on the patient.

Surgeons who prefer working with X-rays can now use the enhanced HipInsight system to create “future X-rays” that simulate the desired surgical outcome in advance. These projections can be overlaid onto real-time intraoperative X-rays using the mixed-reality device, enabling live comparison during the procedure. Additionally, the system now offers rapid assessment of changes in leg length and hip width.

“I’m grateful that there are physicians who are willing to put the time in and have the interest in figuring out a better way,” Clapp stated, “because it all benefits the patient.”

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