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Maryland Orthopedic Specialists
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CARTIHEAL Agili-C — Aragonite Biphasic Scaffold

Fellowship-trained cartilage restoration surgeons Christopher Raffo, MD and John Christoforetti, MD offer the CARTIHEAL Agili-C implant — the only FDA-approved off-the-shelf cartilage repair device proven superior to microfracture in a multicenter randomized controlled trial.

Duration: 60–90 minutesAnesthesia: General or spinal
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What is cartiheal agili-c — aragonite biphasic scaffold?

CARTIHEAL Agili-C is an FDA-approved, off-the-shelf aragonite biphasic scaffold that repairs both articular cartilage and subchondral bone in a single arthroscopic procedure. It is indicated for ICRS Grade III–IV knee lesions (1–7 cm²) and uniquely approved for use in patients with mild to moderate knee osteoarthritis (KL Grade 0–3), making it available to a broader patient population than MACI. The landmark RCT demonstrated 87% reduction in risk of total knee replacement vs standard care at 4 years.

The procedure

What Is the CARTIHEAL Agili-C Implant?

The Science: A Biphasic Aragonite Scaffold

The CARTIHEAL Agili-C Implant (CartiHeal, acquired by Smith+Nephew) is an off-the-shelf, cell-free, biodegradable biphasic scaffold derived from purified, inorganic coral exoskeleton. Coral aragonite shares a three-dimensional microarchitecture strikingly similar to human cancellous bone — a structural resemblance that underpins the implant's regenerative capability.

The device is engineered in two distinct phases:

  • Chondral (upper) layer: Mechanically processed with a grid of micro-drilled channels that facilitate adhesion, migration, and differentiation of bone marrow-derived and synovial mesenchymal stem cells into chondrocytes, driving the formation of new articular cartilage at the joint surface.
  • Subchondral bone (lower) layer: Composed of inorganic aragonite with large interconnected macropores (100–200 µm) that support vascular ingrowth and the coordinated activity of osteoclasts and osteoblasts, leading to full remodeling into new subchondral bone.

Critically, the scaffold is cell-free and off-the-shelf. Rather than requiring the patient's own cells to be harvested and expanded in a laboratory, the Agili-C implant recruits the body's own mesenchymal stem cells from local bone marrow and synovial tissue, harnessing the knee's intrinsic regenerative biology. The scaffold progressively biodegrades as the newly regenerated tissue matures, leaving behind hyaline cartilage-like repair tissue and restored subchondral bone.

The current tapered implant design provides superior press-fit stability and self-centering during implantation, which has been associated with dramatically lower revision rates compared to earlier cylindrical designs.

FDA Approval and Regulatory Distinction

The FDA granted the Agili-C Implant Breakthrough Device Designation, an accelerated pathway reserved for technologies that may provide more effective treatment of serious conditions than currently available options. In 2022, the FDA approved the device under Premarket Approval (PMA) P210034 — making it the first and only FDA-approved device for the treatment of cartilage AND osteochondral defects in patients with or without mild to moderate osteoarthritis (Kellgren-Lawrence Grade 0–3).

This distinction is clinically meaningful. No other cartilage restoration device has been FDA-cleared for use in patients with documented arthritis at the treated compartment.

New Category I CPT Code: Effective January 1, 2027

In October 2025, the American Medical Association (AMA) CPT Editorial Panel established a new Category I CPT code specific to procedures involving the CARTIHEAL Agili-C Implant, effective January 1, 2027. Category I codes are the highest tier of CPT recognition — reserved for procedures that are consistent with contemporary medical practice and widely performed. The issuance of this code signals mainstream clinical adoption of the technology and will improve insurance coverage and reimbursement predictability for eligible patients.

How It Differs from MACI

  • Staging — Single-stage arthroscopic — Two-stage (biopsy + implant, 6–8 weeks apart)
  • Availability — Off-the-shelf, immediate — Custom manufactured per patient (~6-week wait)
  • OA patients — Approved through KL Grade 3 (mild-moderate OA) — Requires healthy surrounding cartilage; OA is generally a contraindication
  • Defect type — Osteochondral (bone + cartilage) and chondral — Primarily chondral (surface only)
  • Cells — Cell-free; recruits host MSCs — Patient's own chondrocytes, lab-expanded
  • Cost — Lower (single procedure, no cell processing) — Higher (two OR visits + manufacturing)

Frequently Asked Questions

Am I a candidate if I have arthritis?
Possibly yes — and this is what makes CARTIHEAL Agili-C unique. The implant is the only FDA-approved cartilage restoration device that is indicated through Kellgren-Lawrence Grade 3, meaning patients with mild to moderate osteoarthritis are eligible. If you have been told you have "too much arthritis" for cartilage repair but are not yet a candidate for total knee replacement, CARTIHEAL Agili-C may offer you a biological option that was not previously available. Five-year clinical trial data confirm that patients with OA achieve the same outcomes as those without OA.
How is it different from microfracture?
Microfracture punctures the subchondral bone to stimulate a fibrocartilage healing response — the resulting tissue is fibrocartilage, which is structurally inferior to native hyaline cartilage and frequently degrades over time. CARTIHEAL Agili-C, by contrast, provides a three-dimensional biphasic scaffold that directs the differentiation of mesenchymal stem cells into chondrocytes, producing repair tissue with hyaline cartilage-like characteristics. In the landmark RCT, CARTIHEAL Agili-C achieved a responder rate of 77.8% versus 33.6% for microfracture/debridement, and MRI-confirmed defect fill >75% in 88.5% of patients versus 30.9% with standard of care. The 87% reduction in the risk of TKA or osteotomy at 4 years reinforces the durability advantage.
How is it different from MACI?
The core differences are staging and eligibility. MACI requires two surgeries (a biopsy followed by implantation 6–8 weeks later), is not available off-the-shelf, and is generally contraindicated in patients with arthritis or osteochondral (bone-involving) defects. CARTIHEAL Agili-C is a single-stage procedure using an immediately available implant, approved for both chondral and osteochondral defects, and uniquely approved through mild-to-moderate OA. Both are biologics-based approaches but serve somewhat different patient populations and clinical scenarios.
How long does it last?
The 5-year data published in AJSM (2026) confirm sustained superiority of CARTIHEAL Agili-C over surgical standard of care at all time points through 60 months — the longest RCT data yet available for any scaffold-based cartilage restoration device. A 4-year analysis found that only 1.2% of Agili-C patients had progressed to total knee replacement versus 9.5% in the control group. Longer-term registry data are accumulating. The implant is fully biodegradable and is replaced by the patient's own regenerated tissue over the course of 12–24 months, so durability ultimately depends on the quality of the regenerated cartilage and subchondral bone — outcomes that the trial data support are durable.
When can I return to sport?
Most patients return to recreational sport between 9 and 12 months following surgery, with return to competitive or high-impact sport often at 12 months or beyond depending on individual progress, functional testing, and MRI findings. Protected weight-bearing is maintained for the first 6 weeks while the scaffold integrates into bone. Progressive rehabilitation advances through months 3–6 with low-impact activity and strengthening. Your MOS rehabilitation team will use objective functional benchmarks — not calendar dates alone — to guide safe return to sport.