Knee implant

anatomicalcobalt-chromium

Overview
The Episealer® Knee – personalised implants and instruments for treatment of cartilage and bone defects. The individualised design of the Episealer implants and surgical instruments is based on MR imaging. By data processing, a virtual 3D model of the damaged femoral knee joint is recreated and the lesion is defined and displayed.

Design and Materials
The Episealer implants and instruments are designed to remove the damaged tissue and restore the area with a perfectly fitting implant. The Episealer is made of cobalt-chrome alloy. The part of the Episealer that is countersunk in the bone and cartilage is covered with a titanium undercoating and a hydroxyapatite outer coating to promote quick and lasting fixation to bone.

Intended Use / Indications
Individualised resurfacing implants intended to treat patients suffering from pain and reduced mobility due to focal cartilage lesions and underlying bone damage in the femoral knee. Episealer is available for the femoral condyles (medial and lateral), the trochlea area, or both.

Implant Variants and Sizes

• Episealer Condyle Solo – individualised resurfacing implant for medial or lateral femoral condyle. Available sizes:
  • 12 mm diameter (treats lesions up to 1.1 cm²)
  • 15 mm diameter (treats lesions up to 1.8 cm²)
  • 17 mm diameter (treats lesions up to 2.3 cm²)
  • 20 mm diameter (treats lesions up to 3.1 cm²)
• Episealer Trochlea Solo – individualised resurfacing implant for the trochlea area. Available sizes presented as table lines:
  20 mm diameter (treats lesions up to 3.1 cm²)
  25 mm diameter (treats lesions up to 4.9 cm²)
  29 mm diameter (treats lesions up to 6.6 cm²)
• Episealer Femoral Twin – for larger/elongated defects on condyles and trochlea. Available sizes:
  • 2 x 15 mm diameter (total length: 23 mm; treats lesions up to 2.9 cm²)
  • 2 x 17 mm diameter (total length: 26 mm; treats lesions up to 3.7 cm²)
  • 2 x 20 mm diameter (total length: 29 mm; treats lesions up to 4.8 cm²)
  • 2 x 25 mm diameter (total length: 35 mm; treats lesions up to 7.3 cm²)

Surgical Instruments and Kit
The Episealer procedure uses an individualised drill guide (Epiguide) and a set of associated single-use tools delivered together with the implant. The kit normally consists of 6 pieces (7 pieces for the Episealer Femoral Twin). Key instruments named on the procedure: Epiguide, Epidrill, Drilling socket and Adjustment socket. The combination of Epiguide and associated tools allows for 0.2 mm precision depth adjustment and precise insertion of the implant at the exact angle and depth relative to the patient’s joint anatomy. The guide is designed to attach to the knee surface around the cartilage lesion, providing a stable platform during drilling and implantation.

Clinical Goal
The treatment is designed to restore the damaged joint surface to alleviate pain and enable patients to recover joint mobility.

Availability Note
Episealer Knee is not available in the United States.

Technical characteristics / specifications

• Custom design based on patient MRI and virtual 3D modelling
• Implant material: cobalt-chrome alloy
• Bone-contact coatings: titanium undercoating + hydroxyapatite outer coating
• Intended anatomical locations: femoral condyles (medial/lateral) and trochlea
• Available implant sizes: see Condyle Solo, Trochlea Solo and Femoral Twin variants above
• Surgical kit: individualised Epiguide + associated single-use tools (6 pieces; 7 for Twin)
• Depth adjustment precision: 0.2 mm (via Epidrill / Drilling socket / Adjustment socket)
• Delivered as patient-specific implant and instrument kit prior to surgery (no hospital stock required)