The ankle fusion nail market size is expected to reach US$ 1,145.2 million by 2030, from US$ 630.5 million in 2023, at a CAGR of 8.9% during the forecast period. Ankle fusion nails are specialized implants used to fuse bones in the ankle joint to relieve chronic pain and improve stability. The surgery helps patients with severe ankle arthritis by eliminating motion and fusing the joint. Ankle fusion nails offer advantages like minimal soft tissue dissection, shorter operating time, and lower rates of nonunion. The rising cases of ankle arthritis and increasing road accidents are the key drivers for the market growth.

The ankle fusion nail market is segmented by product type, material, end-user, indication, fixation type, and region. By product type, the uniplanar nails segment accounts for the largest share of the market. Uniplanar nails provide compression across the tibiotalar joint and are commonly used for ankle arthrodesis procedures. Their simple design and ease of use are driving their adoption.

Ankle Fusion Nail Market Drivers

• Rising Incidence of Ankle Arthritis: Ankle arthritis is one of the leading causes of ankle fusion procedures. The growing incidence of ankle osteoarthritis and rheumatoid arthritis due to obesity, genetics, injuries, and other factors is expected to increase the demand for ankle fusion nails. According to the Arthritis Foundation, in 2021, around 1.3 million Americans suffered from ankle arthritis. The American Orthopedic Foot and Ankle Society estimates around 6,000 and 7,000 ankle fusion procedures were performed in the U.S in 2021, every year due to arthritis. As the burden of ankle arthritis rises globally, the number of ankle fusion surgeries will increase, in turn fueling the growth of the ankle fusion nail market.
• Technological Advancements in Implant Designs: Continuous advancements in implant designs and materials are driving the ankle fusion nail market growth. Companies are developing implants with anatomical shapes, improved locking mechanism, and coatings to enhance bone ingrowth. For instance, Acumed LLC, an orthopaedic medical device original equipment manufacturer; offers Ankle Fusion System featuring Agilon coated intramedullary nails for antibacterial protection. In 2021, Orthofix Medical Inc., a leading medical device company; launched VOS Ankle Fusion Nail with a fluted, tapered design, and four distal locking options. These product developments are improving fusion rates and surgical outcomes, thereby propelling market growth.
• Increasing Road Accidents and Sports Injuries: The rising number of road traffic accidents and sports injuries leading to post-traumatic arthritis is boosting the demand for ankle arthrodesis. According to the World Health Organization (WHO), around 1.3 million people die annually due to road traffic crashes. Sport injuries like fractures, dislocations, and sprains causing ankle instability also require fusion procedures. Growing cases of trauma requiring ankle fusion are expected to support the adoption of specialized fusion nails and screws.
• Rising Geriatric Population: The geriatric population is at a higher risk of degenerative bone disorders like osteoarthritis requiring ankle fusion surgery. According to the United Nation (UN), the global population aged 65 years and above is projected to reach 1.5 billion by 2050. The elderly are more prone to falls and injuries. With improving life expectancy, the growing aging population worldwide presents significant opportunities for market growth during the forecast period.

Ankle Fusion Nail Market Opportunities

• Emerging Markets in Developing Countries: Emerging economies like China, India, Brazil and South Korea present lucrative opportunities owing to improving healthcare infrastructure and rising disposable incomes. The expanding target patient population, rise in medical tourism and growing awareness regarding advanced treatments create prospects for ankle fusion devices in these markets. Local player like Double Medical and global companies are increasing focus on emerging markets to capitalize on the untapped potential and gain share.

Ankle Fusion Nail Market Restraint

• High Cost of Ankle Fusion Surgery: The high cost of ankle fusion surgery ranging between US$ 9,000 to US$ 28,000 in the U.S. depending on implants used and hospital charges is a major restraint limiting the adoption. Additionally, the cost of revision surgeries and expenses related to post-operative complications also add to the economic burden. Lack of favorable reimbursement and low awareness regarding treatable conditions in developing countries hamper uptake. Affordability concerns restrict access to a large patient pool, thereby hindering the market growth to some extent.
• Risk of Nonunion and Other Post-operative Complications: The risks of nonunion, delayed union, and malunion after ankle arthrodesis reduce its clinical desirability and adoption. Post-operative complications like infections, wound issues, nerve injuries, thrombosis, and implant failures may require additional surgeries and hospital stays. These concerns and the extensive 8-12 months recovery period hampers patient preference for the surgery, thereby challenging the market expansion.
• Limited Clinical Evidence Regarding Long-term Outcomes: There is limited high-quality clinical data comparing the long-term outcomes of ankle fusion using nails versus other surgical techniques. The lack of conclusive randomized controlled trials demonstrating clear benefits and disadvantages confuses surgeons regarding optimal implants and approaches. More research is warranted to establish strong clinical evidence and definitive best practice guidelines for ankle arthrodesis. The lack of robust clinical data can make surgeons apprehensive about adopting this technique, hindering the market growth.

• Increasing Adoption of External Fixation Devices: The growing use of external fixation devices for ankle arthrodesis is a key trend influencing market outlook. They offer advantages like earlier weight bearing, compression across joint, and no need for implant removal. Ring fixation systems are gaining popularity owing to the adjustable fixation capabilities and minimal hardware profile. Developing lighter radiolucent frames using advanced materials also boosts their adoption for complex cases.
• Rising Demand for Customized Patient-specific Implants: The demand for patient-matched 3D printed ankle fusion nails tailored to individual anatomy is rising supported by personalized healthcare trends. Custom nails prevent malpositioning and preserve bone stock during surgery. Companies like Stryker, Zimmer Biomet and Wright Medical provide patient-specific additive manufactured implants, bolstering the market growth. Surgeons are increasingly preferring customized nails for better anatomical fit and outcomes.
• Growing Popularity of Ankle Arthroplasty Procedures: The growing popularity of total ankle replacement procedures especially in younger patients is a crucial trend affecting market outlook. Technological enhancements have expanded the eligibility criteria for arthroplasty. The higher motion retention and avoidance of adjacent joint arthritis are increasing its preference over fusion. Market players are diversifying their portfolio by entering the TAA space to capitalize on this trend and compensate for slowing fusion nail sales.
• Increasing Number of Ambulatory Surgery Centers: The rising number of ASCs globally performing outpatient orthopedic procedures is creating opportunities for ankle fusion device manufacturers. Low cost care and greater convenience boosts ASC adoption. Market players are entering partnerships with ASCs to provide implants, instrument sets and on-site support during surgeries. The surging volume of ankle fusions at ASCs compared to hospitals is a significant trend bolstering market prospects.

Ankle Fusion Nail Market Regional Insights

• North America is expected to be the largest market for ankle fusion nail during the forecast period, accounting for over 45.1% of the market share in 2023. The growth of the market in North America is attributed to the high incidence of ankle arthritis, the rising geriatric population, and the presence of major market players in the region.
• Europe is expected to be the second-largest market for ankle fusion nail, accounting for over 25% of the market share in 2023. The growth of the market in Europe is attributed to the favorable reimbursement policies and advanced healthcare infrastructure in the region.
• Asia Pacific is expected to be the fastest-growing market for Ankle Fusion nail, with a CAGR of over 16% during the forecast period. The growth of the market in Asia Pacific is attributed to the improving healthcare expenditure and increasing awareness about ankle fusion procedures in the region.

Figure 1. Global Ankle Fusion Nail Market Share (%), by Region, 2023

Acumed LLC, Arthrex Inc., Stryker Corporation, Smith & Nephew plc, Wright Medical Group N.V., Zimmer Biomet Holdings Inc., Integra LifeSciences, and Orthofix Medical Inc.

New product launches

• In November 2022, Arthrex Inc., a global medical device company and leader in new product development and medical education in orthopedics; launched SpeedLock Ankle Fusion System for tibiotalocalcaneal arthrodesis procedures. It provides compression across joints using a low-profile plate and single-step locking screws.
• In June 2021, Orthofix Medical Inc., a leading medical device company and provider of spinal, orthopedic, bone growth, and motion preservation products; received U.S. FDA approval for the FIREBIRD SI Fusion System, an advanced ankle fusion nail designed for stability and reduced operating time.
• In October 2020, Smith & Nephew plc, a leading portfolio medical technology company across Orthopaedics, Sports Medicine, ENT and Advanced Wound Management; launched TULA Ankle Fusion Nail System, which enables predictable placement and stable ankle fixation. It features a tapered, fluted design for rotational stability.

Acquisition and partnerships

• In January 2022, Stryker Corporation, a medical device company; completed the acquisition of Vocera Communications, a provider of clinical communication and workflow solutions. This enhanced Stryker's products for the ambulatory surgery segment.
• In June 2021, Integra LifeSciences, a global medical device manufacturing company; acquired the assets of Phi Medical, it is a leading air ambulance provider; expanding its ankle fusion nail portfolio with MATRIx Osteoconductive Strip
• In May 2020, Acumed LLC, an orthopaedic medical device; partnered with Tech Mahindra, an Indian multinational Information technology services and consulting company; and A.T.O-matter, an Australian statutory agency and the principle revenue collection body for the Australian Government; to integrate Acumed's ankle fusion system with digital solutions for improved surgical planning and patient outcomes

• By Product Type
• • Uniplanar Nails
  • Multiplanar Nails
  • Others
• By Material
• • Stainless Steel
  • Titanium
  • Others
• By End User
• • Hospitals
  • Ambulatory Surgery Centers
  • Orthopedic Clinics
  • Others
• By Indication
• • Osteoarthritis
  • Rheumatoid Arthritis
  • Post-traumatic Arthritis
  • Others
• By Fixation Type
• • Tibiotalocalcaneal Fusion
  • Pantalar Fusion
  • Tibiotalar Fusion
  • Others
• By Region
• • North America
  • Europe
  • Asia Pacific
  • Latin America
  • Middle East
  • Africa