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Overview

MaioRegen® is a cell-free, resorbable scaffold for the treatment of chondral and osteochondral lesions of the knee and ankle in a single-step procedure. It is intended to treat the subchondral bone as well as the cartilage surface.

It is made from type I collagen of equine origin and magnesium-enriched hydroxyapatite by a patented process, in layers that mirror the structure and chemistry of the osteochondral unit: a collagen layer for the cartilage, and composite collagen and hydroxyapatite layers for the calcified cartilage, subchondral bone and spongy bone.

Features

  • Ready to use, for a one-step procedure
  • Cell-free: colonised by the patient’s own cells
  • Resorbable as new tissue remodels
  • Supplied sterile, in single packs
  • Three thicknesses (Prime, Slim and Chondro+) in five sizes each

Indications

Cartilage and osteochondral lesions of the joint surface, whether traumatic, post-traumatic, degenerative or due to osteochondritis dissecans, in the knee and ankle.

  • MaioRegen Prime (0.6 cm): osteochondral lesions with severe subchondral involvement, including ICRS IVa/IVb, Outerbridge IV, early osteoarthritis (Kellgren-Lawrence I-II, no osteophytes) and osteochondritis dissecans.
  • MaioRegen Slim (0.4 cm): osteochondral lesions with moderate subchondral involvement, including ICRS IVa, Outerbridge IV and early osteoarthritis (Kellgren-Lawrence I-II, no osteophytes).
  • MaioRegen Chondro+ (0.2 cm): cartilage lesions with no or mild subchondral change, including ICRS III and Outerbridge III-IV.

Indications, contraindications, warnings and precautions are listed in the instructions for use (IFU).

How it works

  1. Prepare the site. Damaged tissue is removed, opening the lesion to blood flow from the subchondral bone.
  2. Implant. MaioRegen is fitted into the defect, restoring the anatomy of the joint surface.
  3. Colonise. Its porous structure and chemistry draw in bone-marrow-derived cells, which populate the scaffold.
  4. Regenerate. The cells form cartilage or bone according to each layer, while the scaffold is resorbed as new tissue remodels.

Clinical evidence

Published studies include a level 1 randomised controlled trial comparing MaioRegen with microfracture (Kon et al.), with IKDC subjective, Tegner, KOOS and VAS scores assessed at two years.

Recent publications include a 10-year follow-up in unicompartmental knee osteoarthritis (Solaro 2024); a case series of 100 patients with knee joint-surface lesions treated with the scaffold augmented with filtered bone-marrow aspirate, with a mean follow-up of 54 months and a graft failure rate of 4 % (Kolar et al., Am J Sports Med 2024); and a cohort of patients with knee articular-surface lesions analysed for patient and lesion factors affecting outcome (De Marziani et al., Knee Surg Sports Traumatol Arthrosc 2024). Clinical summaries are available above.

Sizes and ordering

For availability, kit contents or a quote, use Enquire above or call us.

MaioRegen Prime (0.6 cm)5 items
Ref.Description
01600288Rectangle 2.0 × 3.0 cm, 0.6 cm thick
01600286Rectangle 3.0 × 4.0 cm, 0.6 cm thick
01600285Disc Ø 1.2 cm, 0.6 cm thick
01600275Disc Ø 1.5 cm, 0.6 cm thick
01600291Disc Ø 1.8 cm, 0.6 cm thick
MaioRegen Slim (0.4 cm)5 items
Ref.Description
01600289Rectangle 2.0 × 3.0 cm, 0.4 cm thick
01600287Rectangle 3.0 × 4.0 cm, 0.4 cm thick
01600290Disc Ø 1.2 cm, 0.4 cm thick
01600282Disc Ø 1.5 cm, 0.4 cm thick
01600292Disc Ø 1.8 cm, 0.4 cm thick
MaioRegen Chondro+ (0.2 cm)5 items
Ref.Description
01600401Rectangle 2.0 × 3.0 cm, 0.2 cm thick
01600400Rectangle 3.0 × 4.0 cm, 0.2 cm thick
01600403Disc Ø 1.2 cm, 0.2 cm thick
01600405Disc Ø 1.5 cm, 0.2 cm thick
01600404Disc Ø 1.8 cm, 0.2 cm thick
Instruments1 item
Ref.Description
33109MaioRegen Mini-Arthro Kit, for arthroscopic implantation

Codes and sizes are taken from the manufacturer's marketing literature and may change. For current information, check the Fin-Ceramica website or the instructions for use before ordering.

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