SKULL FIXATION PLATES

Restoring skull integrity after trauma or surgery requires precision, safety and reliability. That is why skull fixation plates today are manufactured using 3D printing — a technology that allows recreating a patient’s anatomy with micron-level accuracy.

Unlike standard products, a skull plate printed individually accounts for every curve and shape of the defect. This reduces surgical risks, shortens the procedure duration and delivers an aesthetic outcome.

When the surgeon has access to a ready-made model created for a specific patient, they receive not just a tool but an effective solution that integrates into the body with minimal adaptation. biodrook manufactures custom plates from biocompatible polymers that fully comply with implant material requirements. The entire process from diagnostics to a finished sterilised plate takes 5–7 business days.

Skull Fixation Plates — Biodrook

KEY ADVANTAGES:

Every skull fixation plate is manufactured from the patient’s CT scans, so it replicates the bone shape exactly. During surgery the surgeon does not need to spend time on adjustments — the product fits immediately and precisely, shortening the procedure duration and reducing the risk of complications.

Biocompatible polymers are used in production, combining strength and flexibility. They do not cause rejection, are safe for the body and promote natural tissue regeneration. These materials ensure reliable fixation and comfort for both the patient and the surgeon.

Manufacturing Speed

Manufacturing Speed

5–7 business days

Personalised Approach

Personalised Approach

No adjustment required during surgery

Biocompatible Materials

Biocompatible Materials

Safe and promotes natural tissue regeneration

Quality Control

Quality Control

Multilevel inspection before every surgery

ADDITIONAL ADVANTAGES:

Fast Manufacturing From 24 to 48 hours for production; the finished sterilised product reaches the surgeon in 5–7 business days.
Aesthetic Outcome High modelling precision guarantees natural head contours without deformities or asymmetry after surgery.
Simplified for the Surgeon A ready-made solution developed for a specific clinical case reduces unpredictable situations during surgery.
Quality Assurance Multilevel inspection of geometry, strength and sterility is performed before each product is handed over.

Thanks to 3D printing, all parameters are stable and the result is predictable: the product integrates smoothly into the tissues and ensures a long-lasting effect without complications.

STAGES OF 3D PRINTING A SKULL FIXATION PLATE

Manufacturing an individual skull fixation plate is a clear technological process in which every step matters. All stages sequentially combine medical diagnostics, digital modelling and additive manufacturing to deliver a safe and precise solution.

1. Diagnostics

Everything begins with scanning. The patient undergoes CT or MRI to obtain an accurate three-dimensional model of the damaged area. These data form the basis of the future implant — the quality of the scans determines the precision of every subsequent step.

2. Digital Modelling

At this stage, biodrook engineers and the neurosurgeon together create a precise 3D model of the skull restoration plate. It accounts for the defect shape, bone thickness, anatomical features and attachment zones. Every product is designed from scratch without pre-made templates.

3. 3D Printing

Once the model is approved, printing begins on high-precision equipment. The plate is formed layer by layer from biocompatible polymers, replicating bone contours with micron-level precision. This level of detail guarantees perfect seating in the bone opening and reliable fixation during surgery.

4. Quality Control and Sterilisation

After printing, the product undergoes multilevel inspection: geometry, strength and sterility are assessed. Processing is carried out in accordance with the SAL 10⁻⁶ standard, meaning absolute safety for the patient. Every product has an individual passport listing all production parameters.

5. Handover to the Surgeon

The finished skull plate is packaged in a sterile container and transferred to the operating room together with documentation. The surgeon receives a solution ready for immediate use — precise, safe and tested. This eliminates delays and allows reconstruction to be performed right after manufacturing.

The result is a product that seamlessly integrates into the patient’s anatomy, ensuring reliable skull protection and a predictable recovery.

INDICATIONS

3D printing is most commonly used after complex traumatic brain injuries when a portion of the skull is lost or requires temporary removal to reduce intracranial pressure. An individual skull fixation plate precisely replicates the defect shape, providing reliable protection and restoring the anatomy.

In oncological practice, personalised plates are used after tumour resections. The technology allows rapid production of a product that fills the defect and restores skull contours without delays in treatment.

Indications for skull fixation plates
Skull fixation plates — clinical cases

Another area is reconstruction for congenital or acquired deformities, as well as repeat surgeries where previous methods did not deliver the expected outcome. In clinical practice these situations may include:

  • traumatic brain injuries with loss or temporary removal of skull bone
  • oncological resection of skull tumours
  • reconstruction for congenital or acquired skull deformities
  • repeat surgeries where previous implants or methods failed
  • cases where standard solutions do not provide the required outcome

All these indications share a common goal — to restore the shape, protection and harmony of the skull as safely, quickly and individually as possible for each patient.

CONTRAINDICATIONS

Like any surgical procedure, the use of a skull fixation plate has its limitations. The procedure is not performed in the presence of active infections in the surgical area, severe systemic diseases or conditions that impair tissue healing.

Caution is also required in cases of allergy to the materials or the presence of soft tissue inflammation. In paediatric patients, 3D printing is used only when indicated, during periods when skull growth has stabilised.

Contraindications for skull fixation plates
Skull fixation plates — limitations

The main contraindications are as follows:

  • active infections or inflammatory processes in the surgical area
  • severe systemic diseases or conditions impairing tissue healing
  • allergy to implant materials or presence of soft tissue inflammation
  • paediatric age during active skull growth phases

The decision to manufacture an individual plate is made by the surgeon after a full diagnostic assessment and risk evaluation. This guarantees a safe outcome and correct restoration of the bone structure.

Analysis of the fit accuracy of a custom temporomandibular joint (TMJ) implant
Read the article and watch the surgical video.

Video — Biodrook 3D Printing

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ACCOMPANYING DOCUMENTS

ISO 13485 Сертифікат якості

ISO 13485:2018

Certificate of Conformity

Завантажити ↗
ISO 13485 Сертифікат якості

UA.TR.130.2703-25

Certificate of Conformity

Завантажити ↗
ISO 13485 Сертифікат якості

UA.TR.130.2704-25

Certificate of Conformity

Завантажити ↗

SCIENTIFIC SOURCES

Advances in 3D Printing of Surgical Guides

A detailed study of the accuracy and efficiency of 3D-printed guides in orthopaedic surgery.

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Advances in 3D Printing of Surgical Guides

A detailed study of the accuracy and efficiency of 3D-printed guides in orthopaedic surgery.

Learn more →

Advances in 3D Printing of Surgical Guides

A detailed study of the accuracy and efficiency of 3D-printed guides in orthopaedic surgery.

Learn more →

Advances in 3D Printing of Surgical Guides

A detailed study of the accuracy and efficiency of 3D-printed guides in orthopaedic surgery.

Learn more →
FAQ — Biodrook

FREQUENTLY ASKED QUESTIONS

It is a custom implant that replaces or reinforces a damaged area of the skull. The plate is created from CT scans and printed from a biocompatible polymer that replicates the exact shape of the defect.

They are used in neurosurgery, oncology, reconstructive and plastic medicine. The primary goal is to restore skull integrity after trauma, surgery or resections.

Such products undergo multilevel strength and sterility testing. The materials used comply with ISO 10993 standards: they are non-toxic, biocompatible and resistant to mechanical loads.

Yes, every plate is modelled individually from CT scans. This guarantees an exact match to the defect’s shape and dimensions and eliminates the need for intraoperative adjustments.

Yes. All materials undergo pre-clinical testing in accordance with international standards. Production is conducted under strict quality and sterility control, confirmed by ISO certificates.

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