Tracking 5 Years of FDA 510(k) Clearances

FDA has cleared more than 2,500 devices between 2021 and 2025, with spine outpacing the other major segments in orthopedics for the most clearances over the five-year span, driven in recent years by advances made by smaller companies like SI-BONE, Centinel Spine and Carlsmed. Their successes show that niche spine subsegments, such as SI fusion solutions, carry significant upside.

Although foot and ankle continues to grow in the high single digits, procedure volumes remain stagnant. Case volumes began to decline in late 2023 and remained inconsistent throughout 2024 and into early 2025. Companies in the space are hopeful that foot and ankle will return to strong growth this year. In the meantime, companies are developing new solutions for core trauma, which is providing a runway for growth.

Joint replacement remains the biggest money-making segment in orthopedics with worldwide sales in 2025 of nearly $24 billion and garnered more than 500 clearances since 2021. Robotics hasn’t yet taken hold , but companies are focused on developing digital ecosystems and data feedback loops with the aim of improving patient care and implant designs. Additive manufacturing, cementless knee implants and shoulder replacement surgery continue to gain traction and will future drive innovations in the segment.
Product development efforts in sports medicine have evolved from new ways to treat torn ligaments to devices designed to preserve joint health and the damaging effects of osteoarthritis. Pediatrics has developed into a niche area of interest and growth potential.
What enabling technology lacks in numbers of clearances it more than makes up for in interest and investment throughout the industry. The biggest orthopedic players are developing integrated tech ecosystems to keep pace with the digitization of surgery and competition at the top of the spine and joint replacement markets. Navigation platforms, particularly augmented reality systems, and handheld robotic devices are serving as entry point to high-tech surgery by meeting surgeons where they are along the adoption curve.
Although orthobiologics continue to show tremendous promise in treating joint osteoarthritis, particularly in the knee, and could be introduced in combination with implants in spine and sports medicine procedures, a lack of clinical data backing the effectiveness of therapies and commercial challenges among some of the segment’s players have slowed widespread adoption of these therapies.
 Infographic proudly sponsored by Lincotek Medical.
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