Custom-made

Custom-made craniomaxillofacial implants in Titanium, PEEK, PMMA and porous PEEK with hydroxyapatite designed and manufactured under high quality standards (ISO 13485). 

We provide continuous support and communication with specialists, offering comprehensive assistance pre, during and post-operative. 

Features

*Anatomical, dimensional and geometric fit.
*Reduction of risks associated with surgery and its duration.
*It improves the patient's physical, emotional and mental recovery processes and decreases post-surgical recovery time.
*Improves the functional and esthetic appearance of the patient.
*Highly biocompatible materials.
*Support from the team of engineers and specialists.

*Baja tasa de infección y de rechazo.
*It allows to perform surgical procedures in an efficient time.

CRANIAL IMPLANTS

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Implant or medical device for the permanent replacement of the cranial structure or upper third of the face.

SMARTBONE® custom-made cranial implants are surgically invasive medical devices.

They are obtained one by one according to the needs of each patient, with the use of computer-aided engineering, design software and manufacturing (CAE/CAD/CAM).

Cuentan con un proceso de diseño de alta precisión, es verificado previamente por el especialista y garantiza el ajuste perfecto del implante. Todos los implantes se cotizan uno a uno de acuerdo a su tamaño (S-M-L-XL).

MAXILLOFACIAL IMPLANTS

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Implant or medical device for permanent replacement of the middle or lower third of the face.

SMARTBONE® custom-made maxillofacial implants are surgically invasive medical devices.
They are obtained one by one according to the needs of each patient, with the use of computer-aided engineering, design software and manufacturing (CAE/CAD/CAM).

Cuentan con un proceso de diseño de alta precisión, es verificado previamente por el especialista y garantiza el ajuste perfecto del implante.

All implants are quoted individually according to their complexity.

Material Specifications

Medical Grade Titanium

This material meets ASTM F136 – 13.

Features:
- High mechanical properties
- Osseointegrable (in rough finishes)
- 2 finishes: smooth and roughened
- High biocompatibility level
- Low infection rate (2%)
- Radiopaque material
- Sterilizable by all methods (steam, high energy, ethylene oxide and hydrogen peroxide)
- Resistant to multiple sterilization cycles
- Non-modifiable during surgery
- High mechanical resistance (wear and impact)

PMMA

Also known as “Bone Cement”

Complies with ISO NTC-ISO 13485:2003 standard for medical devices and ASTM F0451-08 standard.

Features:
- Easy postoperative follow-up

- High biocompatibility level (88%)
- Low infection rate (10-12%)
- Radiopaque material
- Sterilizable by all methods (steam, high energy, ethylene oxide and hydrogen peroxide)
- Resistant to multiple sterilization cycles
- Modifiable during surgery
- Avoids thermal conductivity
- High mechanical resistance (wear and impact)

PEEK

Complies with ASTM F2026 – 10.
Features:
- Mechanical properties similar to bone
- Easy postoperative follow-up
- High biocompatibility level
- Low infection rate
- Radiopaque material
- Sterilizable by all methods (steam, high energy, ethylene oxide and hydrogen peroxide)
- Resistant to multiple sterilization cycles
- Modifiable during surgery
- Avoids thermal conductivity
- High mechanical resistance (wear and impact)

Porous PEEK with HA

It is a porous composite of the biocompatible polymer Polyetherethercentone and the biocompatible ceramic hydroxyapatite. Unique in the market.

Complies with ASTM F2026 – 10

Features:
- Mechanical properties similar to bone
- Osseointegrable
- Induces bone bioactivity
- High biocompatibility level
- Low infection rate
- Radiopaque material
- Easy postoperative follow-up
- Sterilizable by all methods (steam, high energy, ethylene oxide and hydrogen peroxide)
- Resistant to multiple sterilization cycles
- Modifiable during surgery
- Can be used in children reducing the need for implant replacement over time.
- Avoids thermal conductivity

Registration no number required

Certification No. 2023019170
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