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INSTRUCTIONS FOR USE (IFU)

Custom-Made Subperiosteal Implant System


1. Device Identification

Device Name: Custom-Made Subperiosteal Implant

Type: Patient-specific, additively manufactured titanium implant

UDI: [To be assigned per device]

Manufacturer: Titania Surgical Ltd, United Kingdom

Device Classification: Custom-made medical device (in accordance with MDR)

2. Intended Purpose

The custom-made subperiosteal implant is intended for the rehabilitation of patients presenting with severe maxillary or mandibular atrophy, where conventional endosseous implant placement is not feasible or contraindicated.

The device is designed to provide structural support for fixed or removable prosthetic restorations.

3. Indications for Use

The device is indicated in:

  • Severe alveolar bone resorption
  • Insufficient bone volume for standard implant placement
  • Patients unsuitable for extensive bone grafting procedures
  • Full arch or partial edentulism requiring prosthetic rehabilitation

4. Contraindications

The device is contraindicated in patients presenting with:

  • Uncontrolled systemic diseases (e.g. uncontrolled diabetes)
  • Active infection at the surgical site
  • Severe parafunctional habits (e.g. uncontrolled bruxism)
  • Poor oral hygiene or lack of compliance
  • Inadequate soft tissue conditions preventing proper coverage

5. Device Description

The implant is a patient-specific titanium framework designed based on CBCT and intraoral scan data. It is manufactured using additive manufacturing technologies and adapted to the cortical bone surface.

The system may include:

  • Subperiosteal framework (titanium)
  • Fixation screws (titanium)
  • Surgical guides (if applicable)
  • Physical models (if applicable)

6. Materials

  • Implant: Medical-grade titanium alloy (e.g. Ti6Al4V ELI)
  • Screws: Titanium alloy
  • Guides (if applicable): Medical-grade polymer or metal

All materials comply with relevant biocompatibility standards.

7. Design and Manufacturing

The device is designed individually for each patient based on clinician prescription and imaging data.

The workflow includes:

  • CBCT acquisition
  • Digital planning and design
  • Additive manufacturing
  • Post-processing and finishing
  • Quality control and verification

8. Sterility and Handling

Unless otherwise specified, the device is supplied non-sterile.

Prior to use:

  • The device must be cleaned and sterilised according to validated protocols
  • Handling must be performed using sterile technique
  • Avoid contamination and mechanical damage

9. Surgical Procedure (General Guidance)

The surgical protocol should be performed by trained clinicians experienced in advanced implantology and maxillofacial surgery.

General steps include:

  1. Flap elevation and exposure of the bone surface
  2. Placement and adaptation of the implant
  3. Fixation using osteosynthesis screws
  4. Verification of stability and passive fit
  5. Soft tissue closure

Specific surgical details depend on the individual case.

10. Warnings and Precautions

  • The device must be used only by qualified professionals
  • Improper placement may lead to implant failure
  • Excessive loading must be avoided during healing
  • Strict aseptic technique is mandatory
  • Post-operative monitoring is essential

11. Possible Complications

Potential complications include:

  • Infection
  • Implant exposure
  • Soft tissue dehiscence
  • Mechanical failure or loosening
  • Patient discomfort or pain

12. Post-Operative Care

  • Antibiotic and analgesic protocols as prescribed
  • Oral hygiene instructions must be followed
  • Regular clinical follow-up is required
  • Gradual loading is recommended

13. Traceability

Each device is uniquely identified by a UDI code.

The UDI ensures full traceability, including:

  • Design data
  • Manufacturing records
  • Patient-specific prescription
  • Delivery and implantation details

14. Storage and Transport

  • Store in a clean, dry environment
  • Avoid mechanical damage
  • Maintain packaging integrity

15. Disposal

The device must be disposed of in accordance with local regulations for medical waste.

16. Legal Statement

This is a custom-made medical device, manufactured in accordance with the prescription of a qualified healthcare professional.

The device is intended for exclusive use by the specified patient.

17. Version Control

IFU Version: v1.0

Date of Issue: [Insert Date]

18. Contact Information

Titania Surgical Ltd

United Kingdom

For technical support or enquiries, contact: contact@titaniamedical.com