The American Medical Association (AMA) CPT Editorial Panel has established a Category I CPT (Current Procedural Terminology) code for Smith+Nephew’s CARTIHEAL AGILI-C Cartilage Repair Implant, effective Jan. 1, 2027. 

The new CPT code recognizes the clinical significance and growing adoption of the CARTIHEAL Implant, a single-stage, off-the-shelf solution for treating cartilage and osteochondral knee defects, including in patients with mild to moderate osteoarthritis (OA). The implant received U.S. Food and Drug Administration (FDA) Breakthrough Device Designation and reportedly is the only FDA-approved device for this indication.  

The Category I CPT code will streamline reimbursement processes for providers and payers, supporting the integration of Smith+Nephew’s CARTIHEAL Implant into standard clinical practice. It also reflects the AMA’s recognition of the procedure’s clinical efficacy, safety, and widespread physician adoption. 

“This code represents a critical milestone on our journey to enable access to patients that can benefit from the CARTIHEAL Implant,” stated Christie Van Geffen, senior vice president of Global Sports Medicine Marketing for Smith+Nephew. 

The CARTIHEAL Implant has demonstrated an 87% reduction in the relative risk of total knee arthroplasty or osteotomy at four years compared to microfracture or debridement, according to data published from a multicenter randomized controlled trial.¹ This positive data and broad knee indication, including OA, provides an additional treatment option for patients earlier in their treatment journey.

The CARTIHEAL Implant is commercially available in the United States and Puerto Rico. The implant is composed of aragonite, a naturally occurring calcium carbonate, and acts as a biphasic scaffold that allows it to repair cartilage and restore subchondral bone.^2-6 

“This new CPT code is a major milestone for physicians and patients alike,” said Dr. Ken Zaslav of Northwell Health. “It validates the clinical value of the CARTIHEAL Implant and facilitates broader access to a technology that fills a true unmet need in the world of cartilage repair.”

Smith+Nephew is focused on repairing, regenerating, and replacing soft and hard tissue. Its 17,000 employees make a difference to patients’ lives through the company’s product portfolio and the invention and application of new technologies across three global business units—Orthopaedics, Sports Medicine & ENT, and Advanced Wound Management. Founded in Hull, United Kingdom, in 1856, Smith+Nephew now operates in 100 countries, and generated $5.8 billion in 2024 sales. Smith+Nephew is a constituent of the FTSE100.

References
¹ Conte P, Anzillotti G, Crawford DC, et al. Differential analysis of the impact of lesions’ location on clinical and radiological outcomes after the implantation of a novel aragonite-based scaffold to treat knee cartilage defects. Int Orthop. 2024;48(12):3117-3126 
² Altschuler N, Zaslav KR, Di Matteo B, et al. Aragonite-Based Scaffold Versus Microfracture and Debridement for the Treatment of Knee Chondral and Osteochondral Lesions: Results of a Multicenter Randomized Controlled Trial. Am J Sports Med. 2023;51(4):957-967. doi:10.1177/03635465231151252
³ Kon E, Di Matteo B, Verdonk P, et al. Aragonite-Based Scaffold for the Treatment of Joint Surface Lesions in Mild to Moderate Osteoarthritic Knees: Results of a 2-Year Multicenter Prospective Study. Am J Sports Med. 2021;49(3):588-598. doi:10.1177/0363546520981750
⁴ Kon E, Filardo G, Shani J, et al. Osteochondral regeneration with a novel aragonite-hyaluronate biphasic scaffold: up to 12-month follow-up study in a goat model. J Orthop Surg Res. 2015;10:81. Published 2015 May 28. doi:10.1186/s13018-015-0211-y
⁵ Matta C, et al. Differentiation.2019;107:24-34.
⁶ Chubinskaya S, et al. Knee Surg Sports Traumatol Arthrosc. 2019;27(6):1953-1964.