Bone Flap Fixation Systems For Craniotomy Procedures

Bone Flap Fixation Systems For Craniotomy Procedures

Clinical investigation to compare the clinical safety and performance of a clamp-like device for craniotomy closure, with the standard of care system, titanium plates and screws.

Inclusion Criteria:

• The subject is 18 years or older.
• The subject can be implanted with the assigned craniotomy closure system according to its Instructions for Use.
• At least one post-operative medical image (CT scan or Magnetic Resonance image) is planned to be performed.
• Life expectancy higher than 6 months.
• The subject is willing to give his/her informed consent and to comply with the required follow-up.

Exclusion Criteria:

• The subject presents any of the contraindications of the assigned craniotomy closure system.
• Orbitozygomatic or mastoid craniotomies.
• Posterior fossa (skull base) surgeries.
• Combined used of craniotomy systems (plates and clamps).
• The subject is currently participating in an investigational drug or device study.