The spine surgery technology market is in the midst of significant changes, with the main players adapting their strategies to respond to shifting industry dynamics.

One notable development arose from Stryker in April, when the company exited the market by selling its U.S. spinal implants business to Viscogliosi Brothers to form VB Spine. The new company will have exclusive access to Stryker’s robotic Mako Spine and Copilot portfolio for use with its implants.

The spine tech market is quite competitive, with innovation leading many companies’ strategies. The market is dominated by a few major players, with Medtronic, Globus Medical, and Johnson & Johnson MedTech controlling over half the market share. Unlike other orthopedic segments like the knee and hip replacement implants market, the spine sector witnesses influxes of new companies and products.

The market has become highly dynamic due to strong surgeon influence, low barriers to entry, and the need for constant innovation. To stay ahead, companies must continually innovate either through the development of new implants, improved surgical techniques, or advanced technologies.

Key spine technology trends include the growing use of robotics, artificial intelligence (AI), and advanced imaging for precision surgery. There is also movement toward minimally invasive techniques, personalized medicine, and new biomaterials for spinal implants.

Highridge Medical

Highridge Medical is a spine company with three strategic pillars: Motion Preservation, Complex Spine/Deformity, and Minimally Invasive Surgery (MIS). The company actively develops in these areas to improve current treatments and address unmet clinical needs. Highridge also explores enabling technologies to help surgeons enhance outcomes, improve safety, and gain procedural efficiency.

The company came to fruition when ZimVie sold its spine division to H.I.G. Capital in April 2024. ZimVie itself was spun out of orthopedic giant Zimmer Biomet, and thus has a rich history of spine solutions supported by clinical evidence and patient outcomes. The company also has a keen eye to notice trends within the industry.

“Artificial intelligence is becoming increasingly prominent in our everyday lives, and the medical device industry is no different,” said Ryan Watson, chief product officer at Highridge Medical. “There is a lot of discussion and groups looking to innovate and explore how spine surgery can benefit from AI. It is an exciting time with a lot of ideas. Seeing these ideas go from concept to reality is likely around the corner and just starting to scratch the surface of what will become possible. As the power of AI lies in the quality and quantity of data, the methods for capturing the data and the quality of the data collected will become increasingly valuable.”

Patient-specific medical devices—another trend in the orthopedic device industry—are custom-made for a patient’s unique anatomy and needs, which can significantly improve personalized treatment and outcomes. Technologies such as advanced imaging and additive manufacturing assist their design and manufacture, creating devices like custom orthopedic implants, dental prosthetics, and specialized surgical guides.

3D modeling and software are used to translate patient imaging data into device designs. Because devices are tailored to the body, they can lead to better comfort and effectiveness. 

“The technology exists to allow us to produce implants that have been tailored to the individual patient, and we see more activity in this space,” said Watson. “Surgical planning is integral in this segment. Equally intriguing as the custom implants are tools being developed to assist surgeons in efficiently creating a surgical plan, then using technology to precisely execute that plan.”

In July, the company revealed it had licensed the U.S. rights of the activL lumbar disc from B. Braun and will develop its own version of the disc for commercial launch later this year. The addition adds lumbar disc arthroplasty to Highridge’s portfolio—the activL disc earned FDA approval in 2015 and gained 510(k) clearance for next-generation instrumentation in 2023.

The company’s Mobi-C cervical disc was the first FDA approved tech for one and two levels in 2013. It’s a cobalt chromium alloy and polyethylene mobile-bearing prosthesis that’s inserted in a single step, without needing bone chiseling or other vertebral anchorage like screws or keels. Smaller, 4.5 mm height Mobi-C implants available in seven footprints to match patient anatomy became available in August 2023.

“We are actively enrolling patients in a clinical trial evaluating the hybrid use of our Mobi-C cervical disc (2-level study with Mobi-C implanted at a level adjacent to a level being treated with a Highridge fusion device),” said Watson. “We believe we have the responsibility to study this new clinical use. Similar to being the first cervical disc in the U.S. to study and receive 2-level indications, we are proud to be leading the charge with this study that may result in new treatment options for patients in need.”

Carlsmed

Traditionally, spinal fusion surgery has relied on “off-the-shelf” implants that aren’t tailored to patient anatomy. The lack of personalization can cause implant-bone mismatch, higher complication and revision rates, and less-than-ideal alignment outcomes. Surgeons are usually forced to choose from dozens of stock options while the patient lies on the operating table, which is inefficient and introduces variability.

“We address this unmet need with aprevo®, an AI-enabled technology platform to assist in surgical planning that ultimately allows the production of patient-specific interbody fusion devices, tailored to each individual’s anatomy, pathology, and a personalized surgical plan,” said Mike Cordonnier, Carlsmed’s chairman and CEO. “By aligning the implant design with the surgeon’s strategy and the patient’s unique spinal structure, aprevo® devices help reduce reoperations, improve alignment, and ultimately may reduce costs for patients and the healthcare system.”

As Highridge’s Watson mentioned, AI is becoming a valuable tool to optimize spine surgery. Carlsmed’s myaprevo app offers simple, engaging, and data-rich 3D plan visualizations. Every patient’s personalized plan and related patient-specific device are visualized, reviewed, and approved through the platform.

“The myaprevo® AI-powered software integrates multiple layers of data, including detailed 3D imaging, patient-specific anatomy and pathology, spinopelvic parameters, surgeon preferences, and real-world outcomes data. Leveraging these inputs, the AI generates a personalized digital plan that enables surgeons to visualize and refine their alignment strategy before entering the OR.”

“AI helps optimize implant fit and positioning, anticipate potential challenges and ensure that the surgical approach is patient-specific,” Cordonnier went on. “Post-operatively, each patient’s imaging is analyzed to generate an aprevo® Intelligence case report, which compares pre-op, planned, and post-op alignment. These reports give surgeons detailed analytics to evaluate patient outcomes against surgical goals, while feeding back into the AI engine to continuously refine and improve future planning.”

In January, the company launched a digital production line that allows it to deliver aprevo personalized spinal fusion implants to hospitals quite quickly. The fully digital production system connects its AI-powered surgical planning platform directly with manufacturing and logistics.

“Once a surgeon finalizes the plan, the device is 3D printed in titanium then packaged sterile, along with a single-use surgical kit,” said Cordonnier. This on-demand, streamlined workflow allows delivery within 10 days of surgical plan approval. The digital production system also ensures scalability, quality, and consistency across every personalized device produced, while simplifying logistics for hospitals and expanding access to personalized spinal fusion procedures.”

Building Blocks

Spine implant manufacturing relies on both subtractive (traditional machining) and additive processes to create implants from materials like titanium and PEEK, with additive methods enabling complex lattice structures for better osseointegration. The process includes design (CAD), printing or machining, post-processing like cleaning and etching, inserting locator pins, and specialized coatings to boost biocompatibility before sterile packaging.

While large OEMs manufacture a good amount of their products in-house, startups, small- and mid-size firms might outsource almost all of their products. Many OEMs have even sold manufacturing facilities to contract manufacturers.

As medical device companies launch technologies in the growing spine surgery market, they often seek manufacturing partners to help them expand production capacity and accelerate product launches. To gain more insights on spine surgery technology manufacturing, Orthopedic Design & Technology spoke to several industry experts over the past few weeks:

• Michel Caillibotte, business development director at Cousin Surgery, a Wervicq-Sud, France-based manufacturer of implants for visceral and spinal surgery with expertise in implantable textiles.
• Milos Dicic, general manager at Tegra Medical’s Hernando, Ms., location. Tegra Medical is a full-service contract manufacturer to the medical device industry.
• Stefan Leonhardt, director of Medical Devices at 3D Systems, a Rock Hill, S.C.-based additive manufacturing solutions partner.
• John Ruggieri, senior vice president, business development, at ARCH Medical Solutions, a Bloomfield Hills, Mich.-based manufacturing partner for precision machining, contract manufacturing, and supply chain integration for medical OEMs.
• Abraham Sayger, sales manager at Tegra Medical’s Hernando, Ms., location.
• Jim Schultz, vice president, sales & marketing, at ECA Medical, a Thousand Oaks, Calif.-based manufacturer of single-use instrumentation for torque-limiting and surgery-ready procedural kits.

Sam Brusco: What trends are you noticing in the spinal implant and instrument manufacturing market?

Michel Caillibotte: We’re seeing implants compatible with endoscopic approaches or extra-minimally invasive surgery, aligned with the principles of spine medicine. These approaches offer benefits for surgical safety, performance, and accelerating recovery. Preserving soft tissue integrity plays a direct role in faster rehabilitation. This trend affects surgical procedures, but more importantly, it influences the sizing and shape of implants. Notable developments include implant downsizing, new artificial ligament solutions, expandable cages or new devices solutions, and alternative materials to pure metal—such as hybrid components combining metals with soft materials that can be deployed and perform locally.

We see implants designed as alternatives to fusion, aiming to maintain or restore the spine’s natural movement. Restoring sagittal balance is the key goal. The motion-preservation mindset is particularly evident in the significant growth of disc prostheses, both mono- and multi-segmented, especially in the cervical spine. Posterior lumbar stabilization also plays a critical role, with mono-segment products. The Vertebral Body Tethering solutions are taking robust ground in the field offering an alternative to multi-level fusions, particularly for young patients in pediatric complex cases.

We also see implants that complement multi-segment fusions, primarily to address Adjacent Segment Disease (ASD). Although fusion still dominates the market, the post-operative complications are driving demand for complementary solutions that improve outcomes. With nearly 40% of revision surgeries/post-surgical cases, there’s a strong push to develop new approaches and improve performance. Biomechanical solutions are being developed to provide stabilization and post-operative spinal support. Ligament augmentation using biotextiles creates a buffer during transitional stress phases and helps prevent non-physiological stress on adjacent discs and vertebrae.

Finally, we see implants integrated with navigation systems. Solutions now must be compatible with robotic and digital environments. The priority is to improve efficiency, enhance predictive capabilities during surgical planning, and gain greater control and confidence in every aspect of surgical practice. Artificial intelligence is a new element in this equation, along with the requirement for implant compliance with robotic systems and hardware to optimize surgical ergonomics.

Milos Dicic & Abraham Sayger: We’re observing a strong shift toward greater product customization and a significantly increased need for shorter lead times. We address these evolving demands through our Genesis Tech Center (GTC), which is entirely dedicated to prototype projects. By allocating dedicated capacity and offering advanced DFM (design for manufacturability) support, we enable fast and reliable turnaround—helping customers bring their innovations to market more quickly and successfully.

At the same time, supply chain resilience is under growing pressure. Recent geopolitical and logistical disruptions have led many OEMs to reassess their sourcing strategies, with increasing interest in nearshoring and dual sourcing. Thanks to our global footprint, we are well-positioned to support these approaches and serve as a key partner in local-for-local manufacturing. This combination of speed, engineering expertise, and supply chain agility is a key differentiator for us in today’s competitive environment.

Stefan Leonhardt: As advances in AM are made, we see additional materials such as PEEK playing more of a role. PEEK received FDA approval in the late 1990s for spinal implant manufacturing. It gained traction for its biocompatibility, radiolucency, and mechanical similarity to human bone. By the 2010s, several studies showcased its high fusion rates and positive patient outcomes, solidifying PEEK spinal cages as the gold standard by the 2010s.

By the mid-2010s, advancements in spinal implant design, including porous structures for enhanced osseointegration, challenged traditional PEEK manufacturing methods like machining and molding. These methods struggled with customization and producing complex geometries, which was becoming more apparent, especially with the rise of patient-specific care. Just like in many other industries, 3D printing has emerged to respond to these challenges. Due to the high temperatures and stringent conditions required for printing PEEK, it took time for 3D printing technology to mature to the point where it could reliably process such high-performance material in complex geometries. And it is not just the equipment, but the overall proprietary process to produce high-quality porous PEEK cages. 

PEEK continues to play a role in spinal implant surgeries, and some of the larger OEMs are exploring how to develop next-generation PEEK implants. With porous PEEK cages as the main driver, AM will be necessary to deliver the mechanical properties needed including the detailed porous structure to promote osseointegration. I believe modified PEEK materials (such as BCP or HA-enhanced) will close the gap, enabling OEMs to deliver more complex devices with improved efficiency.

John Ruggieri: The demand for MIS spinal procedures continues to rise. We see an increase in demand for precision-engineered, smaller and more complex implants and instruments. Titanium and PEEK 3D-printed spinal implants are increasingly favored for their porosity and ability to promote osteointegration. This is also providing us the opportunity to support OEMs with post-processing, finishing, and validation services required for the additive manufacturing process.

There’s the chance to partner in R&D phases, especially for instrumentation that interfaces with robotic platforms and implanted devices. Large OEMs continue to consolidate and streamline their supply chains to fewer, high-performing suppliers. Providing a scale capable of supporting growth and utilizing a multi-site model with redundant capabilities is proving to be a key attribute for developing strong strategic partnerships.

OEMs are seeking faster development cycles, especially for personalized or niche spinal products. Investment in quick-turn prototyping with flexible and agile manufacturing cells play an ever-increasing role with the supplier selection process. Demand for collaborative engineering and rapid iteration support is favored with vertically integrated capabilities such as machining, post-finishing, assembly, and sterile packaging. Patient-specific implants continue to increase with the adoption of tailored implants based on imaging and patient anatomy.

Jim Schultz: There’s a need for cost reduction and simplified instrument sets optimized and tailored for certain procedures. Sterile-pack single-use instruments are on the rise for various procedures including ACDF, interventional pain relief procedures such as SIJ fusions, one- and two-level lumbar fusions, and others.

Brusco: Which new manufacturing technologies are most impacting your spinal implant and instrument business, and how?

Caillibotte: One of the most impactful evolutions is the ability to propose additional patient benefit about biomechanical performance and biological new features (for fast and reliable regeneration).

We operate in a highly versatile and innovative biotextile environment. Our activity is reinforced by integration of advanced soft materials such as silicone, biotextiles, polyurethane (PU), and other soft materials that still are highly reliably performing over time.

Emerging technologies increasingly focus on offering alternatives to traditional metal implants, introducing conformable materials with 3D anatomical shaping and, in some cases, shape-memory properties. These advancements not only enhance surgical performance but also significantly improve ergonomics to ease surgical procedure.

We receive more requests related to enhancing bone growth and investing in spinal medicine, particularly for soft tissue management. This involves use of innovative materials as well as the functionalization of solutions. Our focus is on developing technologies that deliver optimal biomechanical performance while also restoring native function and introducing biological benefits.

Dicic & Sayger: In the manufacture of implants and instruments, the key differences typically lie in product complexity and production volumes. In today’s highly competitive industry, we had to identify technologies and strategies that set us apart. One crucial step was integration of automation technologies into our CNC machinery—addressing both the challenges of workforce shortages and the need for increased productivity.

By developing in-house automation solutions specifically tailored to our manufacturing processes, we’ve successfully bridged the gap between high complexity and variable batch sizes. 

Moreover, digital connectivity has accelerated and complemented these advancements, further strengthening our capabilities. Altogether, these developments reflect our commitment to our vision: to be the most trusted partner in bringing life-changing medical devices to the world.

Leonhardt: We have conducted extensive research and are monitoring clinical outcomes that help us understand the ideal profile of spine implants. 3D printing is paving the way for a new generation of spinal cages, allowing production without compromise on their design. The new cages will be defined by open porous structures that promote bone integration, osseointegrative PEEK variants (BCP/HA enhanced) that promote bone growth, and designs that represent tailored structural solutions with dense areas taking the load only where needed. 

For the first time, with the use of 3D printing, we can rethink implant design by choosing from various lattice structures that establish a baseline of mechanical properties for the cage. By strategically adding dense areas, the stiffness and strength of the cage can be precisely tailored to meet specific surgical and patient needs. This allows for unparalleled control over implant properties, ensuring each cage is optimized for load distribution and fusion outcomes. 3D printing is the only technology that enables production of porous PEEK spinal cages that aren’t only functionally superior but also more adaptable to evolving clinical requirements. With advanced materials such as HA PEEK, we might remove the need for additional coating technologies to help speed production of these devices.

Schultz: There is broader application of advanced polymers that are injection molded and can, in many procedures, meet the loads and stresses that traditionally require titanium and stainless-steel instruments. Pure or partial polymer instruments are often used for measuring devices, probes, stylus, and torque limiters for a wide range of traditional open, MIS, robotic, and high-resolution image and AI assisted surgeries. To achieve needed design margins when a high or wide range of force is likely,  the plastic instrumentation is often coupled with stainless steel or combined with a metal injection molding (MIM) process subcomponent to create a specific part. The MIM process is ideal for single step production of complex shaped components where strength is needed. Linear and nonlinear FEA modeling can help optimize instrument design to mimic the operating conditions and boundary conditions when the instrument is used. This simulation is a powerful productivity tool that can provide design to cost and design for manufacturability solutions and accelerate time to market.