Smith+Nephew announces new category I CPT® code for its CARTIHEAL™ AGILI-C™ Cartilage Repair Implant
Smith+Nephew (NYSE:SNN) announced that the AMA CPT Editorial Panel has established a Category I CPT code for procedures using the CARTIHEAL AGILI-C cartilage repair implant, effective January 1, 2027. The implant is described as a single‑stage, off‑the‑shelf aragonite-based scaffold, commercially available in the United States including Puerto Rico.
The company notes CARTIHEAL has FDA Breakthrough Device designation and is the only FDA‑approved device for this indication. A multicenter randomized trial reported an 87% relative risk reduction in progression to total knee arthroplasty or osteotomy at 4 years versus microfracture/debridement. The new code is expected to streamline reimbursement and broaden clinical access.
Smith+Nephew (NYSE:SNN) ha annunciato che il Panel Editoriale AMA CPT ha istituito un codice CPT di Categoria I per le procedure che utilizzano l'impianto CARTIHEAL AGILI-C per la riparazione della cartilagine, effettivo a partire dal 1 gennaio 2027. L'impianto è descritto come uno scaffold a base di aragonite in un'unica fase, pronto all'uso, disponibile sul mercato statunitense inclusi Porto Rico.
L'azienda osserva che CARTIHEAL ha la designazione FDA Breakthrough Device ed è l'unico dispositivo approvato dalla FDA per questa indicazione. Uno studio multicentrico randomizzato ha riportato una riduzione relativa del rischio dell'87% nella progressione verso artroplastica totale del ginocchio o osteotomia a 4 anni rispetto a microfrattura/desbridement. Si prevede che il nuovo codice snellirà i rimborsi e amplierà l'accesso clinico.
Smith+Nephew (NYSE:SNN) anunció que el Panel Editorial AMA CPT ha establecido un código CPT de Categoría I para los procedimientos que utilizan el implante CARTIHEAL AGILI-C para la reparación del cartílago, con vigencia a partir del 1 de enero de 2027. El implante se describe como un aspa de aragonita de una sola etapa, listo para usar, comercialmente disponible en Estados Unidos, incluyendo Puerto Rico.
La compañía señala que CARTIHEAL tiene la designación de Dispositivo Innovador (Breakthrough Device) de la FDA y es el único dispositivo aprobado por la FDA para esta indicación. Un ensayo multicéntrico aleatorizado reportó una reducción relativa del riesgo del 87% en la progresión hacia artroplastia total de rodilla u osteotomía a 4 años frente a microfractura/desbridamiento. Se espera que el nuevo código agilice el reembolso y amplíe el acceso clínico.
Smith+Nephew (NYSE:SNN) 는 AMA CPT 편집위원회가 CARTIHEAL AGILI-C 연골 재생 이식에 대한 카테고리 I CPT 코드를 제정했으며 2027년 1월 1일 부터 발효된다고 발표했습니다. 이 임플란트는 단일 단계의 현장 사용 가능한 aragonite 기반의 스캐폴드로, 포르토리코를 포함한 미국에서 상업적으로 이용 가능하다고 설명됩니다.
회사는 CARTIHEAL 가 FDA Breakthrough Device 지정 를 받았으며 이 적응증에 대해 FDA 승인을 받은 유일한 기기라고 밝힙니다. 다기관 무작위 시험에서 4년 동안 마이크로프랙처/제기된 제거와 비교하여 총 Knie 인공관절 치환술 또는 골절술로의 진행 위험이 상대 위험도 87% 감소했다고 보고했습니다. 새로운 코드는 보험 청구를 간소화하고 임상 접근성을 넓힐 것으로 기대됩니다.
Smith+Nephew (NYSE:SNN) a annoncé que le Panel éditorial AMA CPT a établi un code CPT de catégorie I pour les procédures utilisant l'implant CARTIHEAL AGILI-C de réparation du cartilage, et ce à compter du 1er janvier 2027. L'implant est décrit comme un échafaudage à base d'aragonite prêt à l'emploi en une seule étape, disponible commercialement aux États-Unis y compris Porto Rico.
L'entreprise indique que CARTIHEAL bénéficie d'une désignation FDA Breakthrough Device et est le seul dispositif approuvé par la FDA pour cette indication. Un essai multicentrique randomisé a rapporté une réduction relative du risque de 87% dans la progression vers une arthroplastie totale du genou ou une ostéotomie sur 4 ans par rapport à la microfracture/débridement. Le nouveau code devrait faciliter le remboursement et élargir l'accès clinique.
Smith+Nephew (NYSE:SNN) kündigte an, dass das AMA CPT Editorial Panel einen Kategorie-I-CPT-Code für Verfahren mit dem CARTIHEAL AGILI-C Knorpelreparaturimplant festgelegt hat, gültig ab dem 1. Januar 2027. Das Implantat wird als einstufiger, sofort einsatzbereiter aragonitbasierter Scaffold beschrieben, der in den Vereinigten Staaten einschließlich Puerto Rico kommerziell erhältlich ist.
Das Unternehmen weist darauf hin, dass CARTIHEAL die FDA Breakthrough Device-Deklaration hat und das einzige von der FDA genehmigte Gerät für diese Indikation ist. Eine multizentrische randomisierte Studie meldete eine relative Risikoreduktion von 87% beim Fortschreiten zu einer totalen Knieendoprothese oder Osteotomie über 4 Jahre im Vergleich zu Mikrofraktur/Desbridement. Es wird erwartet, dass der neue Code die Erstattung erleichtert und den klinischen Zugang erweitert.
Smith+Nephew (NYSE:SNN) أعلنت أن لجنة تحرير AMA CPT قد أقرت رمز CPT من الفئة I للإجراءات التي تستخدم جهاز CARTIHEAL AGILI-C لإصلاح الغضروف، اعتباراً من 1 يناير 2027. يوصف الزرع كـ سقالة مبنية من الأراجونايت على مرحلة واحدة، ومتاحة تجارياً في الولايات المتحدة بما فيها بورتو ريكو.
وتلاحظ الشركة أن CARTIHEAL لديها تفويض FDA Breakthrough Device وهو الجهاز الوحيد المعتمد من FDA لهذه المؤشر. أبلغت تجربة عشوائية متعددة المراكز عن انخفاض مخاطر نسبى قدره 87% في التقدم نحو استبدال مفصل الركبة الكلي أو جراحة العظم خلال 4 سنوات مقارنة بـ microfracture/desbridement. من المتوقع أن يسهل الرمز الجديد التعويضات ويوسع الوصول الإكلينيكي.
Smith+Nephew (NYSE:SNN) 宣布 AMA CPT 编辑小组已为使用 CARTIHEAL AGILI-C 软骨修复植入物的程序设立了 类别 I CPT 码，自 2027 年 1 月 1 日起生效。该植入物被描述为单阶段、现货可用的以方解石基的支架，在美国（包括波多黎各）均有商业供应。
公司指出 CARTIHEAL 获得了 FDA Breakthrough Device 指定，是该适应症唯一获得 FDA 批准的设备。一个多中心随机试验显示，在 4 年时，与微创骨折/清创相比，向全膝关节置换术或截骨术的进展风险相对降低了 87%。预计新代码将简化报销并扩大临床获取。
- Category I CPT code effective Jan 1, 2027
- 87% relative risk reduction for TKA/osteotomy at 4 years
- Holds FDA Breakthrough Device status and is FDA‑approved for indication
- Commercially available in the United States including Puerto Rico
- None.
Insights
New Category I CPT code for Smith+Nephew\'s CARTIHEAL AGILI-C clears a major reimbursement and access hurdle effective
The CPT code formally recognizes procedures using the CARTIHEAL Implant and should simplify claims processing for providers and payers, which materially affects how hospitals and clinics bill for the procedure. The release explicitly links the code to demonstrated clinical outcomes, including an
Key dependencies and risks include actual payer coverage policies, coding adoption by hospitals, and documented utilization patterns despite the code\'s existence; the announcement states the code will "streamline reimbursement" but does not provide specific coverage decisions or pricing. Watch for formal payer coverage policies and hospital coding bulletins over the next 6–18 months and for uptake signals at conferences such as ICRS
Smith+Nephew (LSE:SN, NYSE:SNN), the global medical technology company, today announces that the American Medical Association (AMA) CPT Editorial Panel has established a Category I Current Procedural Terminology (CPT) code for procedures involving its CARTIHEAL AGILI-C Cartilage Repair Implant, effective January 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 defects in the knee, including in patients with mild to moderate osteoarthritis (OA). The implant received Breakthrough Device Designation from the U.S. Food and Drug Administration and is the only FDA-approved device for this indication.
Clinical Impact
The CARTIHEAL Implant demonstrated an
“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.”
Reimbursement and Access
The Category I CPT code will streamline reimbursement processes for providers and payers, supporting the integration of the 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,” said Christie Van Geffen, SVP Global Sports Medicine Marketing for Smith+Nephew.
About the CARTIHEAL AGILI-C Cartilage Repair Implant
The CARTIHEAL Implant is commercially available in the United States, including 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 To learn more about Smith+Nephew’s CARTIHEAL AGILI-C Cartilage Repair Implant, please visit our booth at ICRS 2025 in Boston, MA October 11-13, or visit www.smith-nephew.com/cartiheal.
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Media Enquiries
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Smith+Nephew david.snyder@smith-nephew.com
CPT is a registered trademark of the American Medical Association (AMA). All rights reserved.
References
- 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
- 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
- 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
- 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
- Matta C, et al. Differentiation.2019;107:24-34.
- Chubinskaya S, et al. Knee Surg Sports Traumatol Arthrosc. 2019;27(6):1953-1964.
About Smith+Nephew
Smith+Nephew is a portfolio medical technology business focused on the repair, regeneration and replacement of soft and hard tissue. We exist to restore people’s bodies and their self-belief by using technology to take the limits off living. We call this purpose ‘Life Unlimited’. Our 17,000 employees deliver this mission every day, making a difference to patients’ lives through the excellence of our product portfolio, and the invention and application of new technologies across our three global business units of Orthopaedics, Sports Medicine & ENT and Advanced Wound Management.
Founded in Hull, UK, in 1856, we now operate in around 100 countries, and generated annual sales of
For more information about Smith+Nephew, please visit www.smith-nephew.com and follow us on X, LinkedIn, Instagram or Facebook.
Forward-looking Statements
This document may contain forward-looking statements that may or may not prove accurate. For example, statements regarding expected revenue growth and trading profit margins, market trends and our product pipeline are forward-looking statements. Phrases such as "aim", "plan", "intend", "anticipate", "well-placed", "believe", "estimate", "expect", "target", "consider" and similar expressions are generally intended to identify forward-looking statements. Forward-looking statements involve known and unknown risks, uncertainties and other important factors that could cause actual results to differ materially from what is expressed or implied by the statements. For Smith+Nephew, these factors include: conflicts in Europe and the Middle East, economic and financial conditions in the markets we serve, especially those affecting healthcare providers, payers and customers; price levels for established and innovative medical devices; developments in medical technology; regulatory approvals, reimbursement decisions or other government actions; product defects or recalls or other problems with quality management systems or failure to comply with related regulations; litigation relating to patent or other claims; legal and financial compliance risks and related investigative, remedial or enforcement actions; disruption to our supply chain or operations or those of our suppliers; competition for qualified personnel; strategic actions, including acquisitions and disposals, our success in performing due diligence, valuing and integrating acquired businesses; disruption that may result from transactions or other changes we make in our business plans or organisation to adapt to market developments; relationships with healthcare professionals; reliance on information technology and cybersecurity; disruptions due to natural disasters, weather and climate change related events; changes in customer and other stakeholder sustainability expectations; changes in taxation regulations; effects of foreign exchange volatility; and numerous other matters that affect us or our markets, including those of a political, economic, business, competitive or reputational nature. Please refer to the documents that Smith+Nephew has filed with the U.S. Securities and Exchange Commission under the U.S. Securities Exchange Act of 1934, as amended, including Smith+Nephew's most recent annual report on Form 20-F, which is available on the SEC’s website at www. sec.gov, for a discussion of certain of these factors. Any forward-looking statement is based on information available to Smith+Nephew as of the date of the statement. All written or oral forward-looking statements attributable to Smith+Nephew are qualified by this caution. Smith+Nephew does not undertake any obligation to update or revise any forward-looking statement to reflect any change in circumstances or in Smith+Nephew's expectations.
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FAQ
What change did Smith+Nephew (SNN) announce on October 9, 2025?
How does the CARTIHEAL implant perform versus microfracture for knee lesions?
Will the new CPT code affect reimbursement for CARTIHEAL (SNN)?
Is CARTIHEAL FDA‑designated or approved for its indication?
When will CARTIHEAL procedures be covered under the new CPT code?
Where is CARTIHEAL currently commercially available?
